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Also known as Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine
Hexaxim: DTaP-IPV-Hep B-PRP~T combined vaccine · 1 trial · 6 indications
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...
Hexaxim is a combined vaccine studied for protection against diphtheria, tetanus, whooping cough, hepatitis B, poliomyelitis, and invasive Hib infections. It is given to infants, with the studied population starting at six weeks of age. The Phase 3 trial enrolled healthy infants in India who had already received a hepatitis B vaccine dose at birth.
Hexaxim is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor behind the clinical program for this combined DTaP-IPV-Hep B-PRP~T vaccine.
Hexaxim has been studied in a Phase 3 clinical trial. That trial is listed as completed, and no active trials for this vaccine are currently recorded. It is an investigational combined vaccine rather than a product described here as approved.
Hexaxim was evaluated in the Phase 3 trial NCT01948193, titled Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth. The completed study enrolled 177 healthy infants in India, from six weeks of age, and included both sexes.
Yes. Hexaxim is also written as Hexaxim: DTaP-IPV-Hep B-PRP~T combined vaccine, so the two names refer to the same Sanofi vaccine candidate. The DTaP-IPV-Hep B-PRP~T label describes the combination of diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B, and Hib components.