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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00414050 | A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057) | PHASE3 | COMPLETED | 1,718 | — | — | Oct 6, 2006 | Oct 24, 2007 | May 23, 2017 | - | — |
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 * ...