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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00483574 | Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers | PHASE3 | COMPLETED | 1,378 | — | — | May 1, 2007 | Apr 1, 2009 | May 16, 2016 | 79 | United States, Chile |
Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability
| Arm | Type | Description |
|---|---|---|
| Group 1: Menactra® and Routine Pediatric Vaccines | EXPERIMENTAL | Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate \[PCV\], and hepatitis A \[HepA\]) at age 12 months. |
| Group 2: Routine Pediatric Vaccines | OTHER | Participants received routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate\[PCV\], and hepatitis A \[HepA\]) at age 12 months. |
| Name | Type | Description |
|---|---|---|
| Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate | BIOLOGICAL | 0.5 mL, IM at age 9 and 12 months |
| Measles-mumps-rubella-varicella vaccine | BIOLOGICAL | 0.5 mL, intramuscular at 12 months of age |
| Routine paediatric vaccine - Pneumococcal conjugate (PCV) | BIOLOGICAL | 0.5 mL, Intramuscular at age 12 months |
| Routine paediatric vaccine - Hepatitis A | BIOLOGICAL | 0.5 mL, Intramuscular at age 12 months |
Inclusion Criteria : * Healthy, as determined by medical history and physical examination * Aged 9 months (249 to 305 days) or 12 months (365 to 400 days) at the time of enrollment * The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/Institutional Review Board...