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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00422292 | Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers | PHASE3 | COMPLETED | 1,664 | — | — | Dec 1, 2006 | Apr 1, 2009 | Apr 14, 2016 | 88 | United States, Puerto Rico |
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...