Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MenACYW conjugate vaccine, Meningococcal Polysaccharide Tetanus Toxoid Conjugate
MenQuadfi · 25 trials · 11 indications
30 days post-2nd vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-2nd vaccination for participants with pre-vaccination rSBA titer ≥1:8
30 days (+10 days) post-2nd vaccination with MenACYW conjugate vaccine or MenACYW135, CanSino conjugated vaccine
30 days post-2nd vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-2nd vaccination for participants with pre-vaccination rSBA titer ≥1:8
30 days (+10 days) post-2nd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugated vaccine
30 days post-3rd vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-3rd vaccination for participants with pre-vaccination rSBA titer ≥1:8
30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine or MenACYW135, CanSino conjugate vaccine
30 days post-3rd vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-3rd vaccination for participants with pre-vaccination rSBA titer ≥1:8
30 days (+10 days) post-3rd vaccination of the primary series with MenACYW conjugate vaccine (Group 7) or MenACYW135, CanSino conjugate vaccine (Group 6)
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Antibodies titers are expressed as geometric mean titers
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8
Antibody titers are expressed as geometric mean titers
30 days post-vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30◦days post-vaccination for participants with pre vaccination rSBA titer ≥1:8
Geometric mean titers after a 2-dose serie measured by serum bactericidal assays using human complement (hSBA)
Vaccine seroresponse after a 2-dose serie measured by hSBA
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay utilizing the human complement (hSBA).
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. Percentages are rounded off to the tenth decimal place.
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. Percentages are rounded off to the tenth decimal place.
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. hSBA vaccine seroresponse was defined as follows: for a participant with a pre-vaccination titer \<1:8, the post-vaccination titer must be \>=1:16, and for a participant with a pre-vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre-vaccination titer. Percentages are rounded off to the tenth decimal place.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the study vaccine administered) which occurred within the first 30 minutes after vaccination.
A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site considered to be related to the study vaccine administered and were commonly inflammatory reactions. Systemic ARs were all ARs that were not injection site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An SAE was any AE that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was other medically important event. An AESI (serious or non-serious) was one of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor was appropriate.
Antibody (Ab) titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 16 months of age (\[Group 1 + Group 3\] versus \[Group 2 + Group 4\]) The following threshold values will be considered: ≥ 1:8
Ab titers against meningococcal serogroups A, C, Y, and W will be measured in infants and toddlers 6 months to 15 months of age (Group 5 + Group 7) The following threshold values will be considered: ≥ 1:8
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse for serogroups A, C, W, and Y is defined as: percentage of participants with a pre-vaccination titer \< 1:8, who had achieved a post-vaccination titer \>= 1:16 or participants with a pre-vaccination titer \>= 1:8, who had achieved a post-vaccination titer at least 4-fold greater than the pre-vaccination titer. The seroresponse sufficiency was demonstrated if the lower limit of 1-sided 97.5% confidence interval (CI) is \> 75%.
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority data analysis for this outcome measure was planned to be conducted only for Groups 1 and 2, not for Group 3. Group 3 data is reported separately.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Percentages are rounded off to the tenth decimal place. As pre-specified in protocol, the endpoint was assessed in children and adolescents aged 2 to 17 years in India and RSA as combined groups: Group 5 + Group 7 and Group 6 + Group 8 as they received the same dose of MenACYW conjugate vaccine and Menactra® respectively.
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
GMT titers against Meningococcal Serogroup C were measured by hSBA. Titers were expressed in terms of 1/dilution.
Antibody titers against Meningococcal Serogroup C were measured by hSBA.
Antibody titers against Meningococcal Serogroup C were measured by rSBA.
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
GMT titers against Meningococcal Serogroup C were measured by rSBA. Titers were expressed in terms of 1/dilution.
Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the serum bactericidal assay using human complement (hSBA).
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Group 3 data were presented separately.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Percentage of participants with antibody titers \>=1:8 for meningococcal serogroups A, C, Y, and W were reported in this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Group 3.
A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included Injection site tenderness, Injection site erythema, and Injection site swelling and were planned to be collected and reported for each vaccine separately; and not planned to be collected for Rotavirus vaccine as the vaccine was administered orally, and no injection site reactions were expected to occur. Reported AEs for each arm were presented as pre-specified in protocol.
A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.
An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious adverse events (SAEs) and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. Reported AEs for each arm were presented as pre-specified in protocol.
A MAAE was defined as a new onset of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a health care provider's office or Emergency Department. Reported AEs for each arm were presented as pre-specified in protocol.
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Vaccine seroresponse was defined as a post 4th dose (Day 30 after 12-month) hSBA titer \>=1:16 for participants with pre 1st dose (Day 0 before 2-month) hSBA titer less than (\<) 1:8, or at least a 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Percentages are rounded off to the tenth decimal place.
Functional meningococcal antibody activity against serogroups A, C, Y, and W were measured in a serum bactericidal assay utilizing the hSBA. Percentages are rounded off to the tenth decimal place.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay.
Anti-tetanus antibodies were measured by ECL assay.
Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia.
An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event.
Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were planned to be analyzed for the pooled population of MenACYW Conjugate vaccine and Nimenrix® reporting groups.
Antibody titers against Meningococcal Serogroups A, C, Y, and W were measured by hSBA.
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA) assay. Data for this outcome measure was planned to reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by hSBA assay. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination titers \<1:8 or at least a 4-fold increase in post-vaccination hSBA titers from pre- to post-vaccination, for participants with pre-vaccination titers \>=1:8. Data for this outcome measure was planned to be reported for the combined population of Groups 1 and 10, Groups 2 and 11.
Vaccine seroresponse for serogroups A, C, Y, and W was measured by serum bactericidal assay using human complement (hSBA). It was defined as post-vaccination hSBA titers ≥1:16 for participants with pre-vaccination hSBA titers less than (\<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.
Antibody titers of Meningococcal Serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). Data for this outcome measure were not planned to be collected and analyzed for the Menactra® reporting group.
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8.
The serum bactericidal assay using human complement (hSBA) vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8.
A solicited reaction was defined as an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the case report form (CRF) and considered as related to vaccination. Solicited injection site reactions: Tenderness, Erythema, and Swelling. Solicited systemic reactions: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. Grade 3 solicited injection site reactions: Tenderness: cries when injected limb was moved or the movement of the injected limb was reduced; Erythema and Swelling: greater than or equal to (≥) 50 millimeter (mm). Grade 3 solicited systemic reactions: Fever: greater than \[\>\] 39.5 degree Celsius (°C); Vomiting: ≥6 episodes per 24 hours or requiring parenteral hydration; crying abnormal: \>3 hours; Drowsiness: sleeping most of the time or difficult to wake up; Appetite lost: refuses ≥3 feeds or refuses most feeds; Irritability: inconsolable.
Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post vaccination for participants with pre-vaccination hSBA titers \>= 1:8. Data for this outcome measure was not planned to be collected and analyzed for Group 4:Tdap+HPV.
| Arm | Type | Description |
|---|---|---|
| Cohort I: Group 1MenACYW 2-dose schedule | EXPERIMENTAL | 2 doses of MenACYW conjugate vaccine to participants aged 12 through 23 MoA |
| Cohort I: Group 2 MenACYW135, CanSino 2-dose schedule | ACTIVE_COMPARATOR | 2 doses of MenACYW135, CanSino conjugate vaccine to participants aged 12 through 23 MoA |
| Cohort II: Group 3MenACYW 2-dose primary vaccination + 1-dose booster schedule | EXPERIMENTAL | 2-dose primary vaccination and 1-dose booster of MenACYW conjugate vaccine to participants aged 6 through 11 MoA |
| Cohort II: Group 4 MenACYW135, CanSino 2-dose schedule | ACTIVE_COMPARATOR | 2-dose primary vaccination and 1-dose booster of MenACYW135, CanSino conjugate vaccine to participants aged 6 through 11 MoA |
| Cohort III: Group 5 MenACYW 3-dose primary vaccination + 1-dose booster schedule | EXPERIMENTAL | 3-dose primary vaccination and 1-dose booster of MenACYW conjugate vaccine to participants aged 3 through 5 MoA |
| Cohort III: Group 6 MenACYW135, CanSino 3-dose primary vaccination + 1-dose booster schedule | ACTIVE_COMPARATOR | 3-dose primary vaccination and 1-dose booster of MenACYW135, CanSino conjugate vaccine to participants aged 3 through 5 MoA |
| Cohort III: Group 7 MenACYW 3-dose primary vaccination + 1-dose booster schedule | EXPERIMENTAL | 3-dose primary vaccination and 1-dose booster of MenACYW conjugate vaccine to participants aged 2 MoA |
| Group 1 MenACYW1-dose schedule | EXPERIMENTAL | 1 dose of MenACYW conjugate vaccine to participants aged 7 through 17 years of age |
| Group 2 MenACYW135 Ps 1-dose schedule | ACTIVE_COMPARATOR | 1 dose of MenACYW135 polysaccharide vaccine to participants aged 7 through 17 years of age |
| Group 3 MenACYW1-dose schedule | EXPERIMENTAL | 1 dose of MenACYW conjugate vaccine to participants aged 2 through 6 years of age |
| Group 4 Royal MenAC1-dose schedule | ACTIVE_COMPARATOR | 1 dose of Royal's MenAC conjugate vaccine to participants aged 2 through 6 years of age |
| Group 1: MenACYW conjugate vaccine | EXPERIMENTAL | Participants will receive MenACYW Conjugate Vaccine (MenQuadfi®): 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age (MenQuadfi®) |
| Group 2: Nimenrix® | ACTIVE_COMPARATOR | Participants will receive Nimenrix®: 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age |
| MenACYW conjugate vaccine | EXPERIMENTAL | MenACYW conjugate vaccine single injection on Day 01 |
| Groups 1a, 1b and 1c Cohort Ia (India) | EXPERIMENTAL | 2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose at 12 months of age (group 1a) or at 15 months of age (group 1b) or at 16 months of age (group 1c) + co-administered routine pediatric vaccines |
| Group 2 Cohort Ia (India) | ACTIVE_COMPARATOR | 2 injections of Menactra vaccine: at 9 months of age and second dose at 16 months of age + co-administered routine pediatric vaccines |
| Groups 3 Cohort Ib (RSA) | EXPERIMENTAL | 2 injections of MenACYW conjugate vaccine: at 6 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines |
| Group 4 Cohort Ib (RSA) | ACTIVE_COMPARATOR | 2 injections of Menactra vaccine: at 9 months of age and second dose between 12 and 16 months of age + co-administered routine pediatric vaccines |
| Groups 5a and 5b Cohort IIa (India) | EXPERIMENTAL | 3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered at 12 months of age (group 5a) or at 15 months of age (group 5b) + co-administered routine pediatric vaccines |
| Group 6 Cohort IIa (India) | OTHER | routine pediatric vaccines only |
| Group 7 Cohort IIb (RSA) | EXPERIMENTAL | 3 injections of MenACYW conjugate vaccine: at 6-8 weeks of age and second dose at 14-16 weeks of age with a booster dose administered between 12 and 15 months of age + co-administered routine pediatric vaccines |
| Group 8 Cohort IIb (RSA) | OTHER | routine pediatric vaccines only |
| Group 1 | EXPERIMENTAL | Participants will receive a first booster dose of MenACYW conjugate vaccine at Day 1 and a second booster dose at year 5 of study MEQ00073 |
| Group 2 | EXPERIMENTAL | Participants will receive a single booster dose of MenACYW conjugate vaccine at year 5 of study MEQ00073 |
| Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | EXPERIMENTAL | Participants received 0.5-milliliter (mL) intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31. |
| Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration) | ACTIVE_COMPARATOR | Participants received 0.5-mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31. |
| Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration) | EXPERIMENTAL | Participants received 0.5-mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01. |
| Group 2: Menactra® vaccine | ACTIVE_COMPARATOR | Participants received a single IM dose of Menactra® vaccine on Day 0. |
| Group 3 | EXPERIMENTAL | MenACYW conjugate vaccine, 1 vaccination, adults in India aged ≥ 56 years |
| Group 4 | ACTIVE_COMPARATOR | Quadri Meningo™, 1 vaccination, adults in India aged ≥ 56 years |
| Group 5 | EXPERIMENTAL | MenACYW conjugate vaccine, 1 vaccination, children and adolescents in India aged 2 to 17 years |
| Group 6 | ACTIVE_COMPARATOR | Menactra®, 1 vaccination, children and adolescents in India aged 2 to 17 years |
| Group 7 | EXPERIMENTAL | MenACYW conjugate vaccine, 1 vaccination, children and adolescents in RSA aged 2 to 17 years |
| Group 8 | ACTIVE_COMPARATOR | Menactra®, 1 vaccination, children and adolescents in RSA aged 2 to 17 years |
| Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants) | EXPERIMENTAL | Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066). |
| Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants) | EXPERIMENTAL | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066). |
| Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants) | EXPERIMENTAL | Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066). |
| Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants) | EXPERIMENTAL | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066). |
| Group 5: Menomune-primed Participants (MET44) | OTHER | Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066). |
| Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44) | OTHER | Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066). |
| Group 2: Nimenrix® Vaccine | ACTIVE_COMPARATOR | Healthy, toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0. |
| Group 3: NeisVac-C® Vaccine | ACTIVE_COMPARATOR | Healthy, toddlers aged 12 to 23 months received a single dose of NeisVac-C® vaccine on Day 0. |
| Group 1: MenACYW | EXPERIMENTAL | Participants received 3 doses of meningococcal polysaccharide (serogroups A, C, Y and W) tetanus toxoid \[MenACYW conjugate vaccine\] 0.5 milliliter (mL) as an intramuscular (IM) injection at dose 1: 2 months of age (MoA), dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and haemophilus influenzae type b conjugate vaccine \[DTaP-IPV-HB-Hib\], the pneumococcal vaccine (pneumococcal conjugate vaccine \[10-valent, adsorbed\] {PCV10} were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the measles, mumps, rubella (MMR) vaccine was administered at 12 to 18 MoA. |
| Group 2: Nimenrix | ACTIVE_COMPARATOR | Participants received 3 doses of Nimenrix® 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV10 were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. |
| Group 3: MenACYW | EXPERIMENTAL | Participants received 3 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the pneumococcal conjugate vaccine (13-valent, adsorbed) \[PCV13\] were administered in a 2+1 regimen (ie, 2 doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and 1 final dose in the second year of life \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. |
| Group 4: MenACYW | EXPERIMENTAL | Participants received 4 doses of MenACYW conjugate vaccine 0.5 mL as an IM injection at dose 1: 2 MoA, dose 2: 4 MoA, and dose 3: 6 MoA and dose 4: 12 to 18 MoA along with routine pediatric vaccines. The routine pediatric vaccines: hexavalent vaccine (DTaP-IPV-HB-Hib), the PCV13 were administered in a 2+1 regimen (concomitantly with the first and second doses in infancy \[first between 6 and 12 weeks of age and second between 4 to 5 MoA\] and the toddler dose of MenACYW conjugate vaccine \[12 to 18 MoA\]); and the MMR vaccine was administered at 12 to 18 MoA. The third dose of MenACYW conjugate vaccine was administered alone, without any other routine pediatric vaccines. |
| Group 1: MenACYW Conjugate Vaccine (Mexico) | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus toxoid (MenACYW) Conjugate vaccine at the age of Months 2, 6, and 12 along with Prevnar 13®, Hexacima®, vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6 and measles, mumps, rubella (MMR®II) vaccine at the age of Month 12. |
| Group 2: Menveo® (Mexico) | ACTIVE_COMPARATOR | Participants aged 2 months (at the time of enrollment) received Menveo® vaccine at the age of Months 2, 4, 6, and 12 along with Prevnar 13®, Hexacima® vaccines at the age of Months 2, 4, 6 and 12; RotaTeq® vaccine at the age of Months 2, 4 and 6, and MMR®II vaccine at the age of Month 12. |
| Group 3: MenACYW Conjugate Vaccine (Russian Federation) | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 3, 6, and 12 along with Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12. |
| Group 4: Routine Pediatric Vaccines (Russian Federation) | OTHER | Participants aged 2 months (at the time of enrollment) received Prevnar 13® vaccine at the age of Months 2, and 4.5; Pentaxim® vaccine at the age of Months 3, 4.5, and 6; ENGERIX-B® vaccine at the age of Month 6 and MMR vaccine at the age of Month 12. |
| Group 1: MenACYW Conjugate Vaccine + Bexsero® (2, 4, and 12 to 13 Months) | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age. |
| Group 2: MenACYW Conjugate Vaccine + Bexsero® (2 and 4 Months) | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at 3 months and at 12 to 13 months of age, Bexsero® at 2 and 4 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age. |
| Group 3: Bexsero® (2, 4, and 12 to 13 Months) | ACTIVE_COMPARATOR | Participants aged 2 months (at the time of enrollment) received Bexsero® at 2, 4, and 12 to 13 months of age along with Infanrix hexa® vaccine at 2, 3, and 4 months of age; Rotarix® vaccine at 2 and 3 months of age; and Prevenar 13® vaccine at 2 and 4 months of age. |
| Group 2: MENVEO® | ACTIVE_COMPARATOR | Healthy infants aged \>= 42 to \<= 89 days (at the time of enrollment) received MENVEO® Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age. |
| Group 1a | EXPERIMENTAL | MenACYW conjugate vaccine and routine vaccines at 2, 4, 6, and 12 to 15 months of age |
| Group 1b | EXPERIMENTAL | MenACYW conjugate vaccine at 2, 4, 6, and 15 to 18 months of age and routine vaccines at 2, 4, 6, 12 to 15 months of age, and 15 to 18 months of age |
| Group 2a | ACTIVE_COMPARATOR | MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age |
| Group 2b | ACTIVE_COMPARATOR | MENVEO® at 2, 4, 6, and 12 months of age and routine vaccines at 2, 4, 6, 12, and 15 to 18 months of age |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | EXPERIMENTAL | Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | EXPERIMENTAL | Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). |
| Group 1(Meningococcal Vaccine-Naive):MenACYW Conjugate Vaccine | EXPERIMENTAL | Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0. |
| Group 2 (Meningococcal Vaccine-Naive): Nimenrix® | EXPERIMENTAL | Healthy, meningococcal vaccine naive toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0. |
| Group 3 (MenC-Primed): MenACYW Conjugate Vaccine | EXPERIMENTAL | Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of MenACYW Conjugate vaccine on Day 0. |
| Group 4 (MenC-Primed): Nimenrix® | EXPERIMENTAL | Healthy, meningococcal C vaccine primed toddlers aged 12 to 23 months received a single dose of Nimenrix® vaccine on Day 0. |
| Group 2: MENVEO® Vaccine | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0. |
| South Korea(Group1):MenACYW Conjugate + MMR+ Varicella Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0. |
| South Korea (Group 2): MenACYW Conjugate Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. |
| South Korea (Group 3): MMR + Varicella Vaccine | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0. |
| Thailand (Group 10):MenACYW Conjugate +MMR+Varicella Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine, MMR vaccine, and varicella vaccine on Day 0. |
| Thailand (Group 11):MenACYW Conjugate Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. |
| Thailand (Group 12): MMR + Varicella Vaccine | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MMR vaccine and varicella vaccine on Day 0. |
| Mexico (Group 4): MenACYW Conjugate + DTaP-IPV-HB-Hib Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine and diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type-b (DTaP-IPV-HB-Hib) vaccine on Day 0. |
| Mexico (Group 5): MenACYW Conjugate Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. |
| Mexico (Group 6): DTaP-IPV-HB-Hib Vaccine | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 23 months) received single dose of DTaP-IPV-HB-Hib vaccine on Day 0. |
| Russian Federation (Group7): MenACYW Conjugate + PCV13 Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of MenACYW Conjugate vaccine and pneumococcal Conjugate vaccine (PCV13) on Day 0. |
| Russian Federation (Group 8): MenACYW Conjugate Vaccine | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve toddlers (aged 12 to 14 months or 16 to 23 months) received single dose of MenACYW Conjugate vaccine on Day 0. |
| Russian Federation (Group 9): PCV13 Vaccine | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naïve toddlers (aged 15 to 23 months) received single dose of PCV13 vaccine on Day 0. |
| Group 2: Menomune® Vaccine | ACTIVE_COMPARATOR | Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0. |
| MenACYW Conjugate Vaccine Lot 1 | EXPERIMENTAL | Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW conjugate vaccine from lot 1 on Day 0. |
| MenACYW Conjugate Vaccine Lot 2 | EXPERIMENTAL | Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW conjugate vaccine from lot 2 on Day 0. |
| MenACYW Conjugate Vaccine Lot 3 | EXPERIMENTAL | Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW conjugate vaccine from lot 3 on Day 0. |
| Menactra® | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® on Day 0. |
| Group 3: MenACYW Conjugate Vaccine+Tdap+HPV | EXPERIMENTAL | Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of MenACYW Conjugate vaccine, Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap), and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0. |
| Group 4: Tdap+HPV | ACTIVE_COMPARATOR | Healthy, meningococcal-vaccine naïve participants aged 10 to 17 years received a single dose of Tdap and Dose 1 of HPV Vaccine on Day 0. HPV Vaccine Dose 2 and Dose 3 were given at 2 and 6 months, respectively, after Dose 1 given on Day 0. |
| Name | Type | Description |
|---|---|---|
| MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA) | BIOLOGICAL | Pharmaceutical form:Liquid solution-Route of administration:IM injection |
| Menhycia® (ACYW135 Meningococcal Conjugate Vaccine [CRM197]) (CanSino Biologics Inc., China) | BIOLOGICAL | Pharmaceutical form:Lyophilized powder (MenAC conjugate vaccine) and liquid solution (MenYW135 conjugate vaccine)-Route of administration:IM injection |
| MenACYW conjugate vaccine | BIOLOGICAL | Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection |
| MenACYW135 polysaccharide vaccine | BIOLOGICAL | Pharmaceutical form: Lyophilized powder-Route of administration:IM injection |
| MenAC conjugate vaccine | BIOLOGICAL | Pharmaceutical form:Lyophilized powder-Route of administration:IM injection |
| Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form:Liquid solution-Route of administration:Intramuscular injection |
| Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine | BIOLOGICAL | Liquid solution - intramuscular |
| Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | BIOLOGICAL | Liquid solution - intramuscular |
| Oral bivalent types 1 and 3; Poliomyelitis Vaccine (OPV) | BIOLOGICAL | Oral suspension - oral |
| Pneumoccocal Vaccine | BIOLOGICAL | Suspension for injection - intramuscular |
| Measles, Mumps, and Rubella Vaccine live (MMR) | BIOLOGICAL | Lyophilized powder for injection - subcutaneous |
| DTwP-HepB-Hib-IPV vaccine | BIOLOGICAL | Suspension - intramuscular |
| DTaP-IPV-Hib-HepB vaccine | BIOLOGICAL | Liquid solution - intramuscular |
| Hepatitis A vaccine | BIOLOGICAL | Lyophilized powder for injection - subcutaneous |
| Rotavirus vaccine | BIOLOGICAL | Oral solution - oral |
| Typhoid conjugate vaccine (TCV) | BIOLOGICAL | Suspension for injection - intramuscular |
| Measles vaccine | BIOLOGICAL | Freeze-dried powder for reconstitution and injection - subcutaneous |
| Varicella vaccine live | BIOLOGICAL | Sterile powder and diluent for injection - subcutaneous |
| Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) | BIOLOGICAL | Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular |
| Meningococcal group A, C, W-135, and Y conjugate vaccine | BIOLOGICAL | Pharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular |
| Human Papillomavirus 9-valent Vaccine (9vHPV) | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV) | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine | BIOLOGICAL | Pharmaceutical form: solution for injection; Route of administration: intramuscular, 0.5 mL |
| Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine | BIOLOGICAL | Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL |
| Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine | BIOLOGICAL | Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL |
| Blood sample | OTHER | Blood sample for assessment of antibody persistence. |
| Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine | BIOLOGICAL | Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Intramuscular |
| Meningococcal group C polysaccharide Conjugate vaccine adsorbed | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| DTaP-IPV-HB-Hib vaccine | BIOLOGICAL | Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine |
| Pneumococcal vaccine (13-valent) | BIOLOGICAL | Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) |
| Pneumococcal vaccine (10-valent) | BIOLOGICAL | Pneumococcal polysaccharide conjugate vaccine (10-valent, adsorbed) |
| MMR vaccine | BIOLOGICAL | Measles, mumps, and rubella vaccine |
| Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular |
| Measles, Mumps, and Rubella Virus Vaccine Live | BIOLOGICAL | Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous |
| Pneumococcal 13-valent Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine | BIOLOGICAL | Pharmaceutical form: Powder and suspension for injection Route of administration: Intramuscular |
| Hepatitis B Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
| Rotavirus Vaccine, Live, Pentavalent | BIOLOGICAL | Pharmaceutical form: Oral solution Route of administration: Oral |
| Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine | BIOLOGICAL | Pharmaceutical form:Suspension for injection Route of administration: Intramuscular |
| Meningococcal group B vaccine | BIOLOGICAL | Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL |
| Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine | BIOLOGICAL | Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL |
| Human rotavirus RIX4414 strain vaccine | BIOLOGICAL | Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL |
| Pneumococcal 13-valent polysaccharide conjugate vaccine | BIOLOGICAL | Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL |
| Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine) | BIOLOGICAL | Pharmaceutical form: Liquid solution. Route of administration: Intramuscular |
| Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®) | BIOLOGICAL | Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular |
| Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine | BIOLOGICAL | Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular |
| Measles, Mumps, and Rubella Virus Vaccine | BIOLOGICAL | Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous |
| Varicella Virus Vaccine | BIOLOGICAL | Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous |
| MenACYW-135 conjugate vaccine | BIOLOGICAL | Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular |
| DTaP-IPV//Hib vaccine | BIOLOGICAL | DTaP-IPV//Hib vaccine at 2, 4, 6 and 12 to 15 (Group 1a)/15-18 (Group 1b and Group 2) months of age Intramuscular |
| Pentavalent rotavirus vaccine | BIOLOGICAL | Rotavirus vaccine at 2, 4, and 6 months of age, oral solution |
| Measles, mumps, rubella (MMR) vaccine | BIOLOGICAL | MMR vaccine at 12 months of age, Subcutaneous |
| Varicella vaccine | BIOLOGICAL | Varicella vaccine at 12 months of age |
| Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate | BIOLOGICAL | 0.5 milliliter (mL), Intramuscular |
| MMR | BIOLOGICAL | Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous |
| Varicella | BIOLOGICAL | Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous |
| DTaP-IPV-HB-Hib | BIOLOGICAL | Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular |
| PCV13 | BIOLOGICAL | Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular |
| Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined | BIOLOGICAL | 0.5 mL, Subcutaneous (SC), single dose on Day 0. |
| Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine | BIOLOGICAL | 0.5 milliliter (mL), Intramuscular (IM) |
| Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine | BIOLOGICAL | 0.5 mL, IM |
| Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed | BIOLOGICAL | 0.5 mL, IM |
| GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant | BIOLOGICAL | 0.5 mL, IM |
Inclusion Criteria: * For Cohort I: Aged 12 months through 23 months on the day of inclusion. For Cohort II: Aged 6 months through 11 months on the day of inclusion. For Cohort III: Aged 2 months through 5 months on the day of inclusion * Born at full term of pregnancy (≥37 weeks) or born after a g...