Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK2197870A · 1 trial · 2 indications
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
A seropositive subject was defined as a vaccinated subject who had rSBA-MenC ≥ 1:8.
| Arm | Type | Description |
|---|---|---|
| GSK2197870A Group | EXPERIMENTAL | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh. |
| Pediacel Group | ACTIVE_COMPARATOR | Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh. |
| Name | Type | Description |
|---|---|---|
| GSK2197870A | BIOLOGICAL | 3 doses given at 2, 3 and 4 months of age |
| Prevenar™ | BIOLOGICAL | 3 co-administered doses, intramuscular into right thigh |
| Menitorix™ | BIOLOGICAL | 1 booster dose at 12 months of age |
| Pediacel™ | BIOLOGICAL | 3 doses given at 2, 3 and 4 months of age |
| Menjugate™ | BIOLOGICAL | 2 doses given at 3 and 4 months of age |
Inclusion Criteria: All subjects must satisfy the following criteria at study entry: * A male or female infant between, and including, 6 and 12 weeks of age at the time of the first vaccination. * Born after 36 to 42 weeks of gestation. * Subjects who the investigator believes that their parents/ ...
GSK2197870A is an investigational monoclonal antibody being studied for use against Neisseria meningitidis, the bacterium that causes meningococcal disease. It is being evaluated in a Phase 2 clinical trial as a vaccine given as a primary course in infants. The drug is being developed by GSK plc.
GSK2197870A is a monoclonal antibody that targets Neisseria meningitidis, the bacterium responsible for meningococcal infections. As a vaccine, it is designed to elicit an immune response against this pathogen. The drug is being studied for its ability to protect against meningococcal disease in infants.
GSK2197870A is being developed by GSK plc, a global biopharmaceutical company. GSK is conducting clinical trials to evaluate the safety and efficacy of this investigational vaccine. The company's stock is traded under the ticker symbol GSK.
GSK2197870A is currently in Phase 2 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug is being studied for its potential use as a vaccine against Neisseria meningitidis.
GSK2197870A has been studied in one clinical trial, identified as NCT00871338. This Phase 2 study evaluated the vaccine given as a primary course in infants, with 284 participants enrolled. The trial was conducted in the United Kingdom and has been completed.
GSK2197870A is an investigational vaccine being developed to protect against Neisseria meningitidis, the bacterium that causes meningococcal disease. It is a monoclonal antibody-based vaccine, and it is being studied for use in infants. It is not yet approved and is still in clinical development.