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Infanrix/Hib · 1 trial · 3 indications
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...
Infanrix is a vaccine used for the prevention of infections caused by acellular pertussis, tetanus, diphtheria, Haemophilus influenzae type b, meningococcal infections, and rotavirus infections. It is being studied in children as young as 6 weeks old, with clinical trials conducted in the United States and China.
Infanrix is a vaccine that targets bacterial and viral pathogens, specifically acellular pertussis, tetanus, diphtheria, Haemophilus influenzae type b, meningococcal infections, and rotavirus. It works by stimulating the immune system to produce a protective response against these infectious agents.
Infanrix is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the vaccine's immunogenicity, safety, and efficacy in pediatric populations.
Infanrix is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. All four clinical trials listed for Infanrix are Phase 3 studies that have been completed, with a total enrollment of 3,340 participants.
Infanrix has been studied in four completed Phase 3 clinical trials. These include NCT00614614, NCT00696423, NCT01171963, and NCT01449812. The trials evaluated the vaccine's immunogenicity and safety in children, with studies conducted in the United States and China, covering conditions such as meningococcal infections, acellular pertussis, and rotavirus infections.
Infanrix is not the same as GSK Vaccine 134612. In clinical trial NCT00614614, Infanrix is compared to GSK Vaccine 134612, which is a separate investigational vaccine. The study evaluates the immune response and safety of GSK Vaccine 134612 when given at 12-15 months or 15-18 months after priming with GSK Vaccine 792014.