Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Modified Process Hepatitis B Vaccine · 2 trials · 1 indication
A seroresponder was a participant with an anti-hepatitis B surface antibody titer \>=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.
Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
| Arm | Type | Description |
|---|---|---|
| Modified Process Hepatitis B Vaccine in Base Study | EXPERIMENTAL | Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
| ENGERIX-B™ Vaccine in Base Study | EXPERIMENTAL | Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
| 5 µg Modified Process Hepatitis B Vaccine Booster (Group 1) | ACTIVE_COMPARATOR | Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine (Booster Dose). |
| 10 µg ENGERIX-B™ Booster (Group 2) | ACTIVE_COMPARATOR | Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a dose of 10µg/per 0.5 ml ENGERIX-B™ (Booster Dose) |
| 5 µg Modified Process Hepatitis B Vaccine Booster (Group 3) | ACTIVE_COMPARATOR | Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine, (Booster Dose). |
| 10 µg ENGERIX-B™ Booster (Group 4) | ACTIVE_COMPARATOR | Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 10µg/0.5 ml dose of ENGERIX-B™ (Booster Dose). |
| 5 µg Modified Process Hepatitis B Vaccine (Group 5) | EXPERIMENTAL | Participants did not receive a prior vaccination with a hepatitis B vaccine. During the study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine. |
| Name | Type | Description |
|---|---|---|
| Modified Process Hepatitis B Vaccine | BIOLOGICAL | Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study |
| Comparator: Modified Process Hepatitis B Vaccine | BIOLOGICAL | Single dose 5 µg/0.5ml modified process hepatitis B vaccine |
| Comparator: Comparator: ENGERIX-B | BIOLOGICAL | Single dose 10 µg/0.5ml ENGERIX-B |
Inclusion Criteria: * In general good health based on a medical history. * Received 3 doses of an Hepatitis B vaccine in Base Study V232-059, NCT00440531 at least 2 years prior to enrollment in this study. Exclusion Criteria: * Known history of previous Hepatitis B infection. * History of vaccina...
The modified process hepatitis B vaccine is used for the prevention of hepatitis B virus infection and hepatitis B. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 3 clinical development as an investigational vaccine.
The modified process hepatitis B vaccine targets the hepatitis B virus. It is designed to elicit an immune response against the virus to prevent hepatitis B infection. The vaccine is being studied in healthy volunteers and in patients with hepatitis B virus infection.
The modified process hepatitis B vaccine is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The vaccine is currently in Phase 3 clinical trials for the prevention of hepatitis B.
The modified process hepatitis B vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Three Phase 3 trials have been completed, with a total enrollment of 1,682 participants.
The modified process hepatitis B vaccine has been studied in three completed Phase 3 trials: NCT00393523, a booster study in healthy volunteers aged 4 years and older; NCT00440297, a study in predialysis and dialysis patients aged 18 years and older; and NCT01251276, a challenge dose study in healthy adults aged 50 years and older.
The modified process hepatitis B vaccine is a distinct vaccine being developed by Merck & Company, Inc. It is not identified as being the same as other marketed hepatitis B vaccines. The vaccine is being evaluated in clinical trials for its safety and immunogenicity in different populations.