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DTwP-HepB-Hib Vaccine · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| DTwP-HepB-Hib Vaccine | BIOLOGICAL | Open label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age. |
Inclusion Criteria: 1. Male and female subjects ≥ 42 days to ≤ 64 days of age. 2. Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements Exclusion Criteria: 1. Subjects whose parents or lega...
DTwP-HepB-Hib Vaccine is a fully liquid pentavalent vaccine designed to protect infants against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type B. It is given to infants starting at 6 to 8 weeks of age. The vaccine combines multiple antigens in one injection to simplify infant immunization schedules.
DTwP-HepB-Hib Vaccine is being developed by Novartis AG, which trades under the ticker NVS. Novartis conducted the clinical development of this pentavalent vaccine candidate.
DTwP-HepB-Hib Vaccine is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The vaccine remains investigational and has not been approved by the FDA.
DTwP-HepB-Hib Vaccine has been studied in one completed Phase 3 trial, NCT01470287, titled "Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age." The trial enrolled 175 infants in India and evaluated protection against diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae B.
DTwP-HepB-Hib Vaccine is not FDA approved. It is an investigational vaccine that has completed Phase 3 clinical development. The only listed trial, NCT01470287, was conducted in India and has been completed.