Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HBVaxPRO 5 µg · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| HBVaxPRO® 5 µg / 0.5 mL | BIOLOGICAL | 5 µg / 0.5 mL |
| Engerix B® 10 µg / 0.5 mL | BIOLOGICAL | 10 µg |
Inclusion Criteria: * Healthy child of 4 to 7 years of age of either gender, * Child vaccinated with 2 doses of HEXAVAC® during the first 6 months of life and with a 3rd dose of HEXAVAC® before the end of the second year of life or Child vaccinated with 2 doses of INFANRIX®-HEXA during the first 6 ...
HBVAXPRO 5µg is a vaccine used for Hepatitis B and virus diseases. It is being developed by Sanofi for the prevention of Hepatitis B infection. The vaccine is currently in Phase 3 clinical development and is intended for use in healthy children to assess immune response after primary vaccination.
HBVAXPRO 5µg is developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's immunogenicity and safety in pediatric populations.
HBVAXPRO 5µg is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 3 trials are completed and focused on assessing immune responses in healthy children.
HBVAXPRO 5µg has been studied in two completed Phase 3 trials. NCT00693186 assessed anamnestic immune response in children aged 4 to 7 years after primary vaccination with HEXAVAC or INFANRIX-HEXA. NCT02012998 evaluated immunogenicity and safety of a challenge dose in children vaccinated 10 years earlier.
No, HBVAXPRO 5µg is not the same as HEXAVAC or INFANRIX-HEXA. HBVAXPRO is a separate vaccine developed by Sanofi. The clinical trials compare immune responses in children who received primary vaccination with HEXAVAC or INFANRIX-HEXA, followed by a challenge dose of HBVAXPRO.