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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02106390 | Safety and Immunogenicity of GlaxoSmithKline Biologicals Meningococcal Group B Vaccine When Administered Concomitantly With GlaxoSmithKline Biologicals MenACWY Conjugate Vaccine to Healthy Infants | PHASE3 | COMPLETED | 750 | — | — | Jun 5, 2014 | Oct 14, 2016 | Aug 22, 2018 | 7 | Argentina, Mexico |
Human serum bactericidal activity (hSBA) titers against each of the serogroup B indicator strains-H44/76,5/99,NZ98/254 \& M10713 after receiving 4 doses of rMenB+OMV NZ / MenACWY vaccines, concomitantly administered, versus corresponding response in subjects who received rMenB+OMV NZ administered alone, were presented in terms of vaccine group specific geometric mean titers (GMTs). This outcome measure applies to only rMenB+ACWY and rMenB groups as the serogroup B indicator strains were assessed only for these two groups.
hSBA titers against N. meningitidis serogroups A, C, W-135 and Y after receiving four doses of either rMenB+OMV NZ / MenACWY concomitantly administered versus corresponding response in subjects who received MenACWY administered alone were presented in terms of vaccine group specific GMTs. This outcome measure applies to only rMenB+ACWY and MenACWY groups as the serogroups A,C,W-135 \& Y were assessed only for these two groups.
| Arm | Type | Description |
|---|---|---|
| rMenB+ACWY | EXPERIMENTAL | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
| rMENB | ACTIVE_COMPARATOR | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
| MenACWY | ACTIVE_COMPARATOR | Approximately 250 healthy infants who will be vaccinated at 3, 5, 7 and 13 months of age. |
| Name | Type | Description |
|---|---|---|
| Meningococcal group B Vaccine, rMenB+OMV NZ | BIOLOGICAL | 4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251. |
| Meningococcal ACWY Conjugate Vaccine, MenACWY | BIOLOGICAL | 4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251. |
Inclusion Criteria: 1. Healthy 3-month old infants (85-119 days, inclusive) at time of Visit 1 whose parents/legal guardians have given written informed consent after the nature of the study has been explained. 2. Available for all the visits scheduled in the study. 3. In good health as determined ...