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GSK2036874A vaccine · 1 trial · 6 indications
Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
Antibody titers were presented as geometric mean titers (GMTs).
| Arm | Type | Description |
|---|---|---|
| GSK2036874A GROUP 1 | EXPERIMENTAL | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0. |
| GSK2036874A GROUP 2 | EXPERIMENTAL | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0. |
| GSK2036874A GROUP 3 | EXPERIMENTAL | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0. |
| ZILBRIX/HIB/POLIORIX GROUP | ACTIVE_COMPARATOR | Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively. |
| Name | Type | Description |
|---|---|---|
| GSK2036874A vaccine | BIOLOGICAL | Intramuscular, single dose |
| Zilbrix™/Hib vaccine | BIOLOGICAL | Intramuscular, single dose |
| Poliorix™ | BIOLOGICAL | Intramuscular, single dose |
Inclusion Criteria: * A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination. * Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life. * Subjects ...
The GSK2036874A vaccine is an investigational vaccine developed by GSK plc for Haemophilus Influenzae Type b. It is a Phase 2 candidate studied as a booster dose in healthy toddlers. The vaccine falls within the infectious disease therapeutic area and has been evaluated in a single completed clinical trial.
The GSK2036874A vaccine is being studied for Haemophilus Influenzae Type b, with the completed trial also listing tetanus, hepatitis B, whole cell pertussis, diphtheria, and poliomyelitis vaccines among its conditions. It was tested as a booster dose in healthy toddlers aged 12 months and older in the Philippines.
GSK plc, which trades under the ticker GSK, is the developer of the GSK2036874A vaccine. The company sponsored the Phase 2 study evaluating the candidate as a booster dose in healthy toddlers.
The GSK2036874A vaccine is in Phase 2 development. It is an investigational vaccine and is not approved. One Phase 2 trial has been completed, and no trials are currently active.
The GSK2036874A vaccine has been studied in one clinical trial, NCT01106092, titled a study to evaluate the immunogenicity and reactogenicity of a booster dose in healthy toddlers. The Phase 2 trial was completed, enrolled 312 participants, was randomized, double blind, and active controlled.