Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hexaxim: DTaP-IPV-HB-PRP-T Combined Vaccine · 1 trial · 6 indications
Anti-PT and anti-FHA Ab concentrations are determined in terms of endotoxin units per millilitre (EU/mL).
Anti-PT and anti-FHA Ab levels are measured by electrochemiluminescence immunoassay (ECL) and anti-PT and anti-FHA Ab concentrations are determined in terms of EU/mL.
Anti-diphtheria, anti-tetanus, anti-PT and anti-FHA Ab levels are measured by ECL. Anti-poliovirus types 1, 2, and 3 Ab levels are measured by neutralisation assay. Anti-Hep B Ab levels are measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-polyribosylribitol phosphate (PRP) Ab levels are measured using a Farr-type radioimmunoassay (RIA). Ab concentrations are determined as: anti-diphtheria \>=0.01 international units (IU)/mL, \>=0.1 IU/mL, 1.0 IU/mL, anti-tetanus \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-PT and anti-FHA EU/mL, anti-PRP \>=0.15 microgram (mcg)/mL, \>=1.0 mcg/mL, anti-Poliovirus types 1, 2, and 3 Ab titers \>=8 (1/dilution \[dil\]), Anti-Hep B \>=10 milli (m) IU/mL, and \>=100 mIU/mL.
Seroprotection is determined as: anti-diptheria Ab concentrations \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-tetanus Ab concentrations \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-PT and anti-FHA Ab concentrations EU/mL (\>=LLOQ and \>=4\*LLOQ), anti-PRP Ab concentrations \>=0.15 mcg/mL and \>=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers \>=8 (1/dil), anti-Hep B Ab concentrations \>=10 mIU/mL and \>=100 mIU/mL.
Vaccine response is defined for anti-PT and anti-FHA as Ab post-Dose 3 concentrations \>=4\*LLOQ, if pre-Dose (Day 0) Ab concentration is \<4\*LLOQ or 1 month after third dose (Day 90) concentrations \>= pre-Dose Ab concentrations if pre-Dose (Day 0) concentrations \>=4\*LLOQ. Seroconversion for anti-PT and anti-FHA is defined as \>=4-fold Ab concentrations increase from pre-Dose (Day 0) to 1 month after third dose (Day 90).
Anti-diphtheria, anti-tetanus, anti-PT, and anti-FHA Ab levels are measured by ECL. Anti-poliovirus types 1, 2, and 3 Ab levels are measured by neutralisation assay. Anti-Hep B Ab levels are measured by VITROS ECi/ECiQ Immunodiagnostic system using chemiluminescence detection technology. Anti-PRP Ab levels are measured using a Farr-type RIA. Ab concentrations: anti-diphtheria \>=0.01 IU/mL, \>=0.1 IU/mL, \>=1.0 IU/mL, anti-tetanus \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-PT and anti-FHA EU/mL, anti-PRP \>=0.15 mcg/mL, \>=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers \>=8 (1/dil), anti-Hep B \>=10 mIU/mL, and \>=100 mIU/mL.
Seroprotection: anti-diphtheria Ab concentrations \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-tetanus Ab concentrations \>=0.01 IU/mL, \>=0.1 IU/mL, and \>=1.0 IU/mL, anti-PT and anti-FHA Ab concentrations EU/mL (\>=LLOQ and \>=4\*LLOQ), anti-PRP Ab concentrations \>=0.15 mcg/mL and \>=1.0 mcg/mL, anti-poliovirus 1, 2, and 3 Ab titers \>=8 (1/dil), and anti-Hep B Ab concentrations \>=10 mIU/mL and \>=100 mIU/mL.
Vaccine response is defined for anti-PT and anti-FHA as \>=4 fold Ab concentrations increase from pre-dose (Day 0) to 1 month after booster dose (Day 420), if pre-Dose (Day 0) Ab concentrations \<4\*LLOQ; or \>=2 fold Ab concentrations increase from pre- dose (Day 0) to 1 month after booster dose (Day 420), if pre-dose (Day 0) Ab concentrations \>=4\*LLOQ. Seroconversion is defined for anti-PT and anti-FHA as \>=4 fold Ab concentrations increase from pre-dose (Day 0) to 1 month after booster dose.
Booster response is defined for anti-PT and anti-FHA as \>=4 fold Ab concentrations increase from pre-booster (Day 390) to 1 month after booster dose (Day 420), if pre-booster Ab concentrations \<4\*LLOQ; or \>=2 fold Ab concentrations increase from pre-booster (Day 390) to 1 month after booster dose (Day 390) if pre-Booster Ab concentrations \>=4\*LLOQ.
| Arm | Type | Description |
|---|---|---|
| Study Group A | EXPERIMENTAL | HIV exposed and infected infants |
| Study Group B | EXPERIMENTAL | HIV exposed and uninfected infants |
| Name | Type | Description |
|---|---|---|
| Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months |
Inclusion Criteria: (Screening Criteria for the participants mother) * At least 18 years of age at the time of the Screening blood sample draw * Self-reported or maternity-reported HIV infection in the mother Inclusion Criteria: * Born to an adult mother and aged 35 to 56 days (between 5 and 8 w...
Hexaxim is a DTaP-IPV-HB-PRP-T combined vaccine used for immunization against diphtheria, tetanus, pertussis, hepatitis B, and polio. It is being studied in infants, including those exposed to HIV, as a primary series and booster in the second year of life.
Hexaxim is developed by Sanofi, a company traded under the ticker SNY. The vaccine is currently in Phase 3 clinical development for infectious disease indications.
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 to evaluate its safety and immunogenicity.
Hexaxim has one completed Phase 3 trial, NCT02817451, which studied the DTaP-IPV-HB-PRP-T combined vaccine as a primary series and booster in HIV-exposed infected and uninfected infants in South Africa. The trial enrolled 53 participants aged 5 weeks and older.
Yes, Hexaxim is a DTaP-IPV-HB-PRP-T combined vaccine. This combination vaccine includes components for diphtheria, tetanus, pertussis, hepatitis B, and polio, and is being evaluated for use in infants.