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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00551629 | A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002) | PHASE2 | COMPLETED | 708 | — | — | May 1, 2001 | Mar 1, 2003 | Oct 30, 2015 | - | — |
| NCT00551915 | A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003) | PHASE2 | COMPLETED | 756 | — | — | May 1, 2001 | Jan 1, 2003 | Oct 30, 2015 | - | — |
| Arm | Type | Description |
|---|---|---|
| AR51 (12, 10) | EXPERIMENTAL | Participants were vaccinated with 0.5 ml of AR51 (12, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age. |
| PR51 (3, 10) | EXPERIMENTAL | Participants were vaccinated with 0.5 ml of PR51 (3, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age. |
| PR51 (6, 10) | EXPERIMENTAL | Participants were vaccinated with 0.5 ml of PR51 (6, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age. |
| PR51 (6, 15) | EXPERIMENTAL | Participants were vaccinated with 0.5 ml of PR51 (6, 15) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age. |
| PENTACEL™ + RECOMBIVAX HB™ | ACTIVE_COMPARATOR | Participants were vaccinated with 0.5 ml each of PENTACEL™ + RECOMBIVAX HB™ via intramuscular injection as a primary series at 2, 4, and 6 months of age, and with 0.5 ml PENTACEL™ as a booster at 12 to 14 months of age. |
| Name | Type | Description |
|---|---|---|
| AR51 (12, 10) | BIOLOGICAL | vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg |
| PR51 (3, 10) | BIOLOGICAL | vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg |
| PR51 (6, 10) | BIOLOGICAL | vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg |
| PR51 (6, 15) | BIOLOGICAL | vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg |
| PENTACEL™ | BIOLOGICAL | licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label |
| RECOMBIVAX HB™ | BIOLOGICAL | licensed vaccine for hepatitis, administered open-label |
Inclusion Criteria: * Healthy infants 2 months of age who have not received prior vaccinations for Haemophilus influenzae type b (Hib), hepatitis B, Diptheria/Pertussis/Tetanus (DPT), or Polio Exclusion Criteria : * Documented HIV infection (child or mother) * Documented HBsAg-seropositivity (chi...