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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 combination vaccine developed by GSK plc for immunization against tetanus and several other infectious diseases. It is a Phase 2 candidate studied in healthy infants and young children. The program includes three completed Phase 2 trials with a combined enrollment of 1,292 participants.
GSK2202083A vaccine is being studied for protection against tetanus, along with diphtheria, Haemophilus influenzae type b, hepatitis B, poliomyelitis, acellular pertussis, and Neisseria meningitidis. Trials enrolled healthy infants from 8 weeks of age and children from 12 months of age, evaluating it as a primary series and as a booster dose.
GSK2202083A vaccine is developed by GSK plc, which trades under the ticker GSK. The vaccine is manufactured by GlaxoSmithKline Biologicals, the company's vaccine division, and all three Phase 2 trials were sponsored under that biologicals unit.
GSK2202083A vaccine is in Phase 2 clinical development. It is an investigational vaccine and has not been approved by the FDA. Three Phase 2 trials have been completed, and no trials are currently active.
Three completed Phase 2 trials studied GSK2202083A vaccine: NCT01171989 evaluated a booster dose in 391 participants in Poland, NCT01090453 studied healthy infants across Canada, France, and Germany with 480 participants, and NCT00970307 tested a primary series at 2, 3, and 4 months of age in 421 infants in Poland.
The Phase 2 trials were randomized and active-controlled, comparing GSK2202083A vaccine against an active comparator rather than a placebo. They enrolled healthy volunteers, including infants from 8 weeks of age and children from 12 months of age, and assessed immunogenicity and safety. The trials were not double-blind.