Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PedvaxHIB · 1 trial · 2 indications
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...
PedvaxHIB is used for the prevention of Haemophilus influenzae type b disease, a serious bacterial infection. It is an investigational monoclonal antibody being developed by GSK plc for this infectious disease indication. The drug is currently in Phase 3 clinical development.
PedvaxHIB targets Haemophilus influenzae type b, the bacterium that causes invasive diseases such as meningitis and pneumonia. As a monoclonal antibody, it is designed to neutralize this pathogen. The drug is being studied for its safety and efficacy in preventing Hib disease.
PedvaxHIB is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the drug's safety and effectiveness in preventing Haemophilus influenzae type b infection.
PedvaxHIB is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is being evaluated for its safety and efficacy in preventing Haemophilus influenzae type b disease.
PedvaxHIB has one completed Phase 3 clinical trial, NCT00345683, which evaluated the safety of a Hib-MenCY-TT vaccine versus a licensed Hib conjugate vaccine in children aged 12 to 15 months. The trial enrolled 4,021 participants in the United States and Mexico.
PedvaxHIB is not the same as Hib-MenCY-TT. The clinical trial NCT00345683 compared a Hib-MenCY-TT vaccine against a licensed Hib conjugate vaccine, which may include PedvaxHIB as a comparator. PedvaxHIB is a separate investigational monoclonal antibody for Haemophilus influenzae type b.