Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Meningococcal Polysaccharide Diphtheria Conjugate Vaccine · 1 trial · 5 indications
Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.
| Arm | Type | Description |
|---|---|---|
| Menactra® at 9 and 12 Months | EXPERIMENTAL | Participants will received Menactra® vaccination at 9 and 12 months of age. |
| Menactra® at 9 Months and Menactra® + MMRV at 12 Months | EXPERIMENTAL | Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age |
| Menactra® at 9 Months and Menactra® + PCV at 12 Months | EXPERIMENTAL | Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
| MMRV + PCV at 12 Months | ACTIVE_COMPARATOR | Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age |
| Name | Type | Description |
|---|---|---|
| Meningococcal Polysaccharide Diphtheria Conjugate Vaccine | BIOLOGICAL | 0.5 mL dose, intramuscular (IM) |
| Measles, Mumps, Rubella and Varicella | BIOLOGICAL | 0.5 mL dose, SC |
Inclusion Criteria : * Healthy, as determined by medical history and physical examination * Aged 9 months (249 to 291 days) for Groups 1, 2, and 3 or aged 12 months (365 to 386 days) for Group 4 at the time of enrollment * The parent or legal guardian has signed and dated the Institutional Review B...