Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Hepatitis B Vaccine · 1 trial · 1 indication
The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.
| Arm | Type | Description |
|---|---|---|
| Modified Process Hepatitis B vaccine 5 μg | EXPERIMENTAL | Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| RECOMBIVAX HB™ Hepatitis B Vaccine | ACTIVE_COMPARATOR | Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| Modified Process Hepatitis B vaccine 10 μg | EXPERIMENTAL | Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
| ENGERIX-B® | ACTIVE_COMPARATOR | Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
| Name | Type | Description |
|---|---|---|
| Modified Process Hepatitis B Vaccine (Experimental) | BIOLOGICAL | Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm). |
| Hepatitis B Vaccine (Recombinant) | BIOLOGICAL | RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months. |
Inclusion Criteria: * Participant is a healthy infant approximately 2 months of age Exclusion Criteria: * Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant * Participant's birth mother did not receive any prenatal care * ...
Hepatitis B Vaccine is used for the prevention of Hepatitis B, a viral infection that affects the liver. It is being studied in healthy infants as young as 2 months old. The vaccine is designed to trigger an immune response against the Hepatitis B virus, providing protection against the disease.
Hepatitis B Vaccine is developed by Merck & Company, Inc., a pharmaceutical company listed on the stock exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing Hepatitis B.
Hepatitis B Vaccine is in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is designed to assess the vaccine's effectiveness and safety in a larger population of healthy infants.
Hepatitis B Vaccine is being studied in a Phase 3 clinical trial with the identifier NCT00414050. This trial, titled 'A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)', enrolled 1,718 participants and has been completed. The study was randomized, double-blind, and active-controlled.
Yes, Hepatitis B Vaccine is also known as RECOMBIVAX HB, as indicated by the clinical trial title. The trial evaluated two doses of the vaccine, referred to as V232 RECOMBIVAX HB, in healthy infants. This alternative name helps identify the specific vaccine formulation being tested.