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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 used for the prevention of diphtheria, tetanus, whooping cough, hepatitis B, poliomyelitis, and invasive Haemophilus influenzae type b infections. It is being studied in infants, with one completed Phase 3 clinical trial evaluating its use in this population.
Hexaxim is developed by Sanofi, a company traded under the ticker symbol SNY. The vaccine is currently in clinical development and has completed a Phase 3 trial.
Hexaxim is in Phase 3 clinical development. It is an investigational vaccine and has not been approved for use. One Phase 3 trial has been completed, and it remains under investigation for its intended indications.
Hexaxim has one completed Phase 3 clinical trial, identified as NCT01948193. This study evaluated the vaccine in 177 Indian infants who had received a dose of hepatitis B vaccine at birth, assessing its use against diphtheria, tetanus, whooping cough, hepatitis B, poliomyelitis, and invasive Hib infections.
Yes, Hexaxim is also known as DTaP-IPV-Hep B-PRP~T combined vaccine. This name reflects its components: diphtheria, tetanus, acellular pertussis, inactivated poliovirus, hepatitis B, and Haemophilus influenzae type b.