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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02428491 | Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth | PHASE3 | COMPLETED | 354 | — | — | Apr 20, 2015 | Jan 11, 2017 | Apr 5, 2022 | 1 | Vietnam |
Solicited injection site reactions: tenderness, erythema, and swelling (and extensive limb swelling for booster dose). Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite loss, and irritability
| Arm | Type | Description |
|---|---|---|
| DTaP-IPV-HB-PRP~T Vaccine | EXPERIMENTAL | All participants will receive 3 doses of 0.5 mL DTaP-IPV-HB-PRP\~T combined vaccine, intramuscularly, at 2, 3 and 4 months of age (primary series), followed by a booster dose approximately 12 months after the completion of the primary series (at 16 to 17 months of age). |
| Name | Type | Description |
|---|---|---|
| Hexaxim® | BIOLOGICAL | DTaP-IPV-Hep B-PRP-T combined vaccine, 0.5 mL, Intramuscular |
Inclusion Criteria: * Aged 61 to 91 days on the day of the first study visit * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥2.5 kg * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if ...