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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00345683 | Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age. | PHASE3 | COMPLETED | 4,021 | — | — | Jul 1, 2007 | Nov 1, 2008 | Nov 29, 2016 | 57 | United States, Mexico |
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
| Arm | Type | Description |
|---|---|---|
| Menhibrix Group | EXPERIMENTAL | Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. |
| ActHIB Group | ACTIVE_COMPARATOR | Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014) | BIOLOGICAL | Booster dose by intramuscular injection |
| PedvaxHIB | BIOLOGICAL | Booster dose by intramuscular injection |
| Prevnar | BIOLOGICAL | Booster dose by intramuscular injection |
| M-M-R II | BIOLOGICAL | Single dose by subcutaneous injection |
| Varivax | BIOLOGICAL | Single dose by subcutaneous injection |
Inclusion Criteria: * Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study Exclusion Criteria: Subjects should not be administered M-M-R II and Varivax if any of these criteria apply: * History of measles, mumps, rubella or varicella. * Previou...