Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01049035 | A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers | PHASE2 | COMPLETED | 580 | — | — | Dec 16, 2009 | Feb 13, 2012 | Mar 28, 2022 | 25 | United States |
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. The PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not receive the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provide a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-vaccination titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was \<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with pre-vaccination titer \<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post vaccination) were reported.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer at the age of Month 13 (i.e. 30-days post vaccination at Month 12) were reported.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was \<1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-vaccination titer was defined as titer value reported before the age of 12 months. Percentage of participants with pre-vaccination titer \<1:8 and who achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP which was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.
Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with GMFR in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis \[pertussis toxoid \[PT\], pertactin \[PRN\], filamentous hemagglutinin \[FHA\], and fimbriae \[FIM\]\], Anti-poliovirus \[anti-poliovirus Type 1, Type 2 and Type 3\] and anti-tetanus) were reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis \[PT, PRN, FHA, and FIM\], Anti-poliovirus \[anti-poliovirus Type 1, Type 2, and Type 3\], and Anti-tetanus) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F, and 23F is reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.
Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported.
Antibodies responses were measured by ELISA. Antigens contained in M-M-RII: Measles, Mumps, and Rubella and in Varivax®: Varicella. Percentage of participants with anti-measles, anti-mumps, anti-rubella, and anti-varicella antibody concentration that met the respective mentioned criterion were reported: Measles: ≥255 milli-International Units per milliliter (mIU/mL); Mumps: ≥10 Antibody units per milliliter (AbU/mL); Rubella: ≥10 International Units per milliliter (IU/mL); Varicella: ≥5 glycoprotein based enzyme-linked immunosorbent assay (gpELISA) unit/mL. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.
Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.
Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.
Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC.
Solicited injection site reactions: tenderness/pain, erythema, and swelling and were planned to be collected and reported for each vaccine separately and not planned to be collected for Rotavirus vaccine. Here, '0' in number analyzed field for MenACYW categories signifies no participant were evaluable because in Groups 6 and 7 MenACYW vaccine was not administered; for Group 5, '0' in number analyzed field signifies safety data collection was not planned for Pentacel and Hepatitis-B vaccines; for Groups 2 and 7, '0' in number analyzed field signifies safety data collection was not planned for M-M-RII and VARIVAX vaccines, as pre-specified.
An solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). Systemic AEs were all AEs that were not injection site reactions. They, therefore, include systemic manifestations as well as localized or topical manifestations that were not associated with the vaccination site. Solicited systemic reactions included Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events.
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events. Immediate Unsolicited AE were AEs reported within 30 minutes of vaccine administration.
| Arm | Type | Description |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein (MenACYW) Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months. |
| Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15. |
| Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months | EXPERIMENTAL | Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12. |
| Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months | EXPERIMENTAL | Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2. |
| Group 5: MenACYW Conjugate Vaccine: Month 12 | EXPERIMENTAL | Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6. |
| Group 6: Control: 2, 4, 6, and 12 Months | OTHER | Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months. |
| Group 7: Control: 2, 4, 6, 12, and 15 Months | OTHER | Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15. |
| Name | Type | Description |
|---|---|---|
| Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate | BIOLOGICAL | 0.5 milliliter (mL), Intramuscular (IM) injection |
| Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined) | BIOLOGICAL | 0.5 mL, IM injection |
| M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live | BIOLOGICAL | 0.5 mL, Subcutaneous (SC) injection |
| Varicella Virus Vaccine Live | BIOLOGICAL | 0.5 mL, SC injection |
| Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) | BIOLOGICAL | 0.5 mL, IM injection |
| Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) | BIOLOGICAL | 0.5 mL, IM injection |
| Rotavirus Vaccine | BIOLOGICAL | oral |
| Hepatitis B Vaccine | BIOLOGICAL | 0.5 mL, IM injection |
Inclusion Criteria: * Groups 1, 2, 3, 6, and 7: Aged 42 to 89 days on the day of inclusion; Group 4: Aged 6 months (180 days ± 14 days) on the day of inclusion; Group 5: Aged 12 months (365 days + 14 days) on the day of inclusion. * Born at full term of pregnancy (greater than or equal to \[≥\] 37 ...