Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Zilbrix-Hib · 1 trial · 5 indications
A seroprotected subject was defined as a subject with anti-PRP concentrations greater than or equal to (≥) 0.15 microgram per milliliter (µg/mL).
| Arm | Type | Description |
|---|---|---|
| TRITANRIX-HEPB/HIBERIX KFT. GROUP | EXPERIMENTAL | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ Kft. vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
| TRITANRIX-HEPB/HIBERIX LD GROUP | ACTIVE_COMPARATOR | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ low-dose (LD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
| TRITANRIX-HEPB/HIBERIX HD GROUP | ACTIVE_COMPARATOR | Subjects, male or female, aged 6 to 8 weeks received 3 doses of Tritanrix™-HepB/Hiberix™ high-dose (HD) formulation vaccine, administered intramuscularly in the anterolateral thigh at 6, 10 and 14 weeks of age. |
| Name | Type | Description |
|---|---|---|
| Zilbrix-Hib | BIOLOGICAL | Intramuscular injection, 1 dose |
| Tritanrix™-HepB/ Hiberix™ | BIOLOGICAL | Intramuscular injection, 1 dose |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination. * Written inform...
Zilbrix-Hib is an investigational vaccine being studied for the prevention of Whole Cell Pertussis, along with Haemophilus influenzae type b, tetanus, diphtheria, and hepatitis B. It is in Phase 3 clinical development for use in infectious disease.
Zilbrix-Hib is being developed by GSK plc, a biopharmaceutical company traded on the stock exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy.
Zilbrix-Hib is currently in Phase 3 clinical development. It is an investigational vaccine, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness.
Zilbrix-Hib has one completed Phase 3 clinical trial registered under NCT00473668. This trial was a non-inferiority study comparing Zilbrix-Hib to two formulations of GSK's DTPw-HBV/Hib vaccine, enrolling 300 participants in India.
No, Zilbrix-Hib is classified as a vaccine, not a monoclonal antibody. It is being developed for the prevention of infectious diseases including Whole Cell Pertussis, Haemophilus influenzae type b, tetanus, diphtheria, and hepatitis B.