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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00772928 | Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™ | PHASE3 | COMPLETED | 1,167 | — | — | Oct 1, 2003 | Nov 1, 2006 | Feb 1, 2012 | 23 | United States |
Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses.
Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.
| Arm | Type | Description |
|---|---|---|
| Pentacel™ concurrently with Prevnar® | EXPERIMENTAL | Participants had Pentacel™ concurrently administered with Prevnar® |
| Pentacel™ staggered schedule with Prevnar® | EXPERIMENTAL | Participants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule). |
| Name | Type | Description |
|---|---|---|
| Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria : * Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age. * Infants with at least 36 weeks of gestation at delivery. * Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines). * Able to attend the schedul...