Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01251276 | Hepatitis B Challenge Dose in Adults (V232-059-10) | PHASE3 | COMPLETED | 204 | — | — | Nov 30, 2010 | Apr 12, 2011 | Sep 13, 2022 | - | — |
| NCT00393523 | Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED) | PHASE3 | COMPLETED | 1,478 | — | — | Sep 1, 2006 | Jun 1, 2008 | Apr 12, 2017 | - | — |
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...