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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00412854 | Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib. | PHASE3 | COMPLETED | 660 | — | — | Jan 3, 2007 | Jun 25, 2007 | Jun 6, 2018 | 2 | China |
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).
A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).
The vaccine response was defined as it follows: * for PT and FHA, an antibody concentration higher than or equal to (≥) 20 EL.U/mL at post-vaccination; * for PRN, at least a 4-fold increase in antibody concentration from pre-vaccination to post-vaccination time points.
| Name | Type | Description |
|---|---|---|
| Infanrix™/Hib | BIOLOGICAL | - |
| Infanrix | BIOLOGICAL | - |
| Hiberix | BIOLOGICAL | - |
Inclusion Criteria: * A male or female between, and including, 90 and 120 days of age at the time of the first vaccination, * written informed consent obtained from the parent or guardian of the subject Exclusion Criteria: * Subjects with known exposure to diphtheria, tetanus, pertussis and/or Ha...