Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MenACYW conjugate vaccine · 6 trials · 6 indications
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, W, and Y were measured in a serum bactericidal assay utilizing the serum bactericidal assay using human complement (hSBA).
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 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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 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). |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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 group A, C, W-135, and Y conjugate vaccine | BIOLOGICAL | Meningococcal group A, C, W-135, and Y conjugate vaccine, 0.5 mL, 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 |
| 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 |
| Pneumococcal 13-valent conjugate vaccine | BIOLOGICAL | Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular |
| Pentavalent rotavirus vaccine | BIOLOGICAL | Rotavirus vaccine at 2, 4, and 6 months of age, oral solution |
| Hepatitis B vaccine | BIOLOGICAL | Hepatitis B vaccine at 2 and 6 months of age, Intramuscular |
| Measles, mumps, rubella (MMR) vaccine | BIOLOGICAL | MMR vaccine at 12 months of age, Subcutaneous |
| Varicella vaccine | BIOLOGICAL | Varicella vaccine at 12 months of age |
| Hepatitis A vaccine | BIOLOGICAL | Hepatitis A vaccine at 15 to 18 months of age |
| 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 |
Inclusion Criteria: * For Cohort I: Aged 7 to 17 years on the day of inclusion ("7 to 17 years" means from the day of the 7th birthday to the day before the 18th birthday.). For Cohort II: Aged 2 to 6 years on the day of inclusion (2 to 6 years" means from the day of the 2nd birthday to the day bef...
MenACYW conjugate vaccine is an investigational quadrivalent meningococcal conjugate vaccine being developed to protect against meningitis and meningococcal infections caused by serogroups A, C, W, and Y. It is being studied in healthy infants, toddlers, and children, including as a booster dose and when given alongside routine pediatric vaccines.
MenACYW conjugate vaccine is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting Phase 3 clinical trials to evaluate the vaccine's immunogenicity and safety in pediatric populations.
MenACYW conjugate vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Multiple Phase 3 trials have been completed, evaluating the vaccine's safety and immunogenicity in infants, toddlers, and children.
MenACYW conjugate vaccine has been studied in several Phase 3 trials, including NCT03205371 in toddlers, NCT03476135 as a booster in children, NCT03537508 in US infants and toddlers, and NCT03547271 in European infants and toddlers. These trials assessed immunogenicity and safety when given alone or with routine pediatric vaccines.
MenACYW conjugate vaccine is designed to elicit an immune response against Neisseria meningitidis serogroups A, C, W, and Y. By conjugating the bacterial polysaccharides to a carrier protein, the vaccine aims to produce protective antibodies that prevent meningococcal disease, including meningitis.
MenACYW conjugate vaccine is also known as MenQuadfi, a quadrivalent meningococcal conjugate vaccine developed by Sanofi. It is designed to protect against meningococcal serogroups A, C, W, and Y and is being evaluated in pediatric populations through Phase 3 clinical trials.