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Meningococcal conjugate vaccine GSK134612 · 1 trial · 1 indication
Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
| Arm | Type | Description |
|---|---|---|
| Menitorix Group | EXPERIMENTAL | Subjects who were primed with Menitorix™ (Hib-MenC-TT) + Priorix™ (MMR) vaccines in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1). The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| Meningitec + Hiberix Group | EXPERIMENTAL | Subjects who were primed with Meningitec™ (MCC) + Hiberix™ (Hib) + Priorix™ (MMR) vaccine in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1). The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Meningococcal conjugate vaccine GSK134612 | BIOLOGICAL | Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm |
Inclusion Criteria: * Subjects' parent(s)/Legally Acceptable Representative(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * A male or female between, and including, 84 and 95 months of age at the time of the booster vaccination. * Written in...
Meningococcal conjugate vaccine GSK134612 is an investigational vaccine developed by GSK plc for the prevention of meningococcal infections. It is designed to protect against meningococcal disease and is being studied in healthy volunteers. The vaccine is in Phase 3 clinical development and has been evaluated in a completed trial.
Meningococcal conjugate vaccine GSK134612 is intended for the prevention of meningococcal infections. It targets meningococcal disease, a serious bacterial infection. The vaccine is being developed for use in healthy individuals, with clinical evaluation focused on immunogenicity, reactogenicity, and safety in subjects who received a primary meningococcal C vaccination.
Meningococcal conjugate vaccine GSK134612 is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this meningococcal conjugate vaccine candidate.
Meningococcal conjugate vaccine GSK134612 is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by the FDA. One Phase 3 trial has been completed, and no active trials are currently listed for this candidate.
Meningococcal conjugate vaccine GSK134612 has been studied in one completed Phase 3 trial, NCT01777308. The trial evaluated the immunogenicity, reactogenicity, and safety of the MenACWY-TT vaccine administered six years after MenC primary vaccination in healthy subjects who were 12 to 18 months old at primary vaccination. It enrolled 156 participants in Australia.