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GSK2202083A vaccine · 3 trials · 8 indications
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (μg/mL).
A seroprotected subject was defined as a subject with anti-rSBA-MenC titers greater than or equal to (≥) 1:8.
The anti-PRP antibody concentration cut-off for this assay was greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL).
The rSBA-MenC antibody titers cut-off for this assay was ≥ 1:8.
A seroprotected subject was defined as a subject with rSBA-MenC titers greater than or equal to (≥) 1:8.
| Arm | Type | Description |
|---|---|---|
| GSK2202083A + SYNFLORIX GROUP | EXPERIMENTAL | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
| INFANRIX HEXA/MENJUGATE GROUP | ACTIVE_COMPARATOR | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
| INFANRIX HEXA/NEISVAC-C + SYNFLORIX GROUP | ACTIVE_COMPARATOR | Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh. |
| GSK2202083A Group | EXPERIMENTAL | Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age. |
| Infanrix hexa Group | ACTIVE_COMPARATOR | Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age. |
| INFANRIX HEXA + MENJUGATE GROUP | ACTIVE_COMPARATOR | Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. |
| INFANRIX HEXA + SYNFLORIX GROUP | ACTIVE_COMPARATOR | Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally. |
| Name | Type | Description |
|---|---|---|
| GSK2202083A vaccine | BIOLOGICAL | Intramuscular, one dose. |
| Infanrix hexa™ | BIOLOGICAL | Intramuscular, one dose. |
| Menjugate™ | BIOLOGICAL | Intramuscular, one dose. |
| NeisVac-C™ | BIOLOGICAL | Intramuscular, one dose. |
| Synflorix™ | BIOLOGICAL | Intramuscular, one dose. |
| Prevenar 13® | BIOLOGICAL | 3 co-administered doses |
| Menjugate® | BIOLOGICAL | 3 co-administered doses |
| Rotarix™ | BIOLOGICAL | Oral, two doses |
| 10-valent pneumococcal vaccine (GSK 1024850A) | BIOLOGICAL | Intramuscular, three doses |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol. * Subjects who have completed the full three-dose primary vaccination course according to their group allocation in the primar...
GSK2202083A vaccine is an investigational vaccine being studied for the prevention of tetanus, along with other diseases including diphtheria, Haemophilus influenzae type b, poliomyelitis, acellular pertussis, hepatitis B, and Neisseria meningitidis. It is currently in Phase 2 clinical development for use in healthy infants and as a booster dose.
GSK2202083A vaccine is being developed by GSK plc, a global biopharma company listed on the London Stock Exchange under the ticker GSK. The vaccine is part of GSK's infectious disease portfolio and is currently in Phase 2 clinical trials.
GSK2202083A vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Three Phase 2 trials have been completed, with a total of 1,292 participants enrolled across studies in Poland, Canada, France, and Germany.
GSK2202083A vaccine has completed three Phase 2 clinical trials: NCT00970307, a study in healthy infants at 2, 3, and 4 months of age in Poland; NCT01090453, a study in healthy infants in Canada, France, and Germany; and NCT01171989, a booster dose study in Poland. All trials are completed.
GSK2202083A vaccine is classified as a monoclonal antibody modality, though it is being studied as a vaccine. It is administered to healthy infants and as a booster dose to prevent tetanus and other infectious diseases. The vaccine is in Phase 2 clinical development.