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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00441012 | Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED) | PHASE3 | COMPLETED | 546 | — | — | Dec 1, 2006 | Jun 1, 2008 | Mar 19, 2015 | - | — |
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Modified process Hib/Hep B vaccine |
| 2 | ACTIVE_COMPARATOR | COMVAX™ |
| Name | Type | Description |
|---|---|---|
| Comparator: Modified Process Vaccine | BIOLOGICAL | Modified process vaccine HBsAg 5 ug/0.5 mL and PRP \[OMPC\] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 \& 12 months of age. Duration of treatment is 11 months. |
| Comparator: COMVAX™ | BIOLOGICAL | COMVAX™ HBsAg 5 ug/0.5 mL and PRP \[OMPC\] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months. |
Inclusion Criteria: * Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier mothers Exclusion Criteria: * Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or known carriers ever living in close contact with the subject * History of previous hepatitis...