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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01948193 | Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth | PHASE3 | COMPLETED | 177 | — | — | Feb 1, 2014 | Jun 1, 2015 | Oct 20, 2015 | 2 | India |
Diphtheria antibodies were measured by a toxin neutralization test, tetanus antibodies by an enzyme-linked immunosorbent assay (ELISA), Haemophilus influenzae type b polysaccharide (PRP) antibodies by Farr type radioimmunoassay, poliovirus 1, 2, and 3 antibodies by a neutralization assay, and Hepatitis B (Hep B) antibodies were measured by VITROS ECi/ECiQ Immunodiagnostic System. Description of seroprotection: Diphtheria and Tetanus antibody concentrations ≥0.01 International Units (IU)/mL; Poliovirus 1, 2, and 3 titers ≥8 (1/dilution); Hep B concentrations ≥10 mIU/mL, and PRP ≥0.15 µg/mL.
Anti-pertussis toxin (PT) and anti-filamentous hemagglutinin (FHA) antibodies were measured with an ELISA. Vaccine response was defined as percentage of participants with post-dose 3 anti-PT and anti-FHA antibody concentrations in ELISA units (EU)/mL ≥ 4 x Lower Limit of Quantification (LLOQ) if pre-vaccination concentration was \< 4 x LLOQ or ≥ pre-vaccination concentration if pre-vaccination concentrations ≥ 4 x LLOQ.
| Arm | Type | Description |
|---|---|---|
| Study Group | EXPERIMENTAL | Participants will receive Sanofi Pasteur's DTaP-IPV-Hep B-PRP\~T combined vaccine (investigational vaccine) at 6, 10 and 14 weeks of age. |
| Name | Type | Description |
|---|---|---|
| Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged between 42-56 days (6 to 8 weeks) on the day of inclusion * Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * Informed consent form signed by the parent(s) or any other legally acceptable representative * Subject and parent/legally acceptable re...