Approval Probability
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Also known as GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)
GSK Biologicals' Meningococcal vaccine GSK134612 · 2 trials · 1 indication
Vaccine response to MenC was defined as: -for initially seronegative subjects \[i.e. rSBA-MenC titer below (\<) 1:8\], antibody titer greater than or equal to (≥) 1:32; -for initially seropositive (i.e. rSBA-MenC titer ≥ 1:8), antibody titer post-vaccination ≥ 4-fold the pre-vaccination antibody titer.
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Antibody titers were expressed as Geometric mean titers (GMTs)
Antibody titers were expressed as Geometric mean titers (GMTs)
The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).
Antibody titers were expressed as Geometric mean titers (GMTs)
The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8
Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)
| Arm | Type | Description |
|---|---|---|
| Nimenrix Group | EXPERIMENTAL | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Nimenrix™ vaccine into the non-dominant deltoid region, at Day 0. |
| Menjugate Group | ACTIVE_COMPARATOR | Healthy male or female subjects between, and including 2 and 10 years of age, intramuscularly received 1 dose of Menjugate® vaccine into the non-dominant thigh region, at Day 0. |
| Menhibrix 1 Group | EXPERIMENTAL | Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) \[Nimenrix 1 Group\] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) \[Menhibrix 2 Group\], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) \[Nimenrix 2 Group\]. |
| ActHIB- Infanrix Group | ACTIVE_COMPARATOR | Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age and 1 booster dose of Infanrix vaccine at 15-18 months of age. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' meningococcal vaccine GSK134612 | BIOLOGICAL | Intramuscular administration, 1 dose |
| Menjugate | BIOLOGICAL | Intramuscular administration, 1 dose |
| GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix) | BIOLOGICAL | One dose in the booster phase as intramuscular injection |
| GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix) | BIOLOGICAL | Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection |
| Infanrix® | BIOLOGICAL | One dose as intramuscular injection |
| ActHIB® | BIOLOGICAL | Three doses in the priming phase as intramuscular injection |
| Pediarix® | BIOLOGICAL | Three doses in the priming phase as intramuscular injection |
Inclusion Criteria: * Subjects whose parents/guardians, the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including, 2 and 10 years of age at the time of the vaccination. * Written informed consent obtained from the parent(s) or gua...
GSK Biologicals' Meningococcal vaccine GSK134612 is an investigational vaccine developed by GSK plc for the prevention of meningococcal infections. It is a Phase 3 vaccine candidate studied in healthy children and infants. The program includes two completed Phase 3 trials with a combined enrollment of 1,972 participants.
GSK Biologicals' Meningococcal vaccine GSK134612 is being developed for the prevention of meningococcal infections. Its clinical program has evaluated the vaccine in healthy children and infants, including a study comparing it with a licensed MenC-CRM197 vaccine in children aged 2 years and older.
GSK Biologicals' Meningococcal vaccine GSK134612 is developed by GSK plc, which trades under the ticker GSK. GSK Biologicals is the vaccine unit associated with the program.
GSK Biologicals' Meningococcal vaccine GSK134612 is in Phase 3 development. Both of its Phase 3 trials are completed, and no trials are currently active. The vaccine is investigational and has not been established as approved for use.
GSK Biologicals' Meningococcal vaccine GSK134612 has been studied in two completed Phase 3 trials. NCT00674583 compared the vaccine with a licensed MenC-CRM197 vaccine in healthy children in France and Germany, enrolling 414 participants. NCT00614614 assessed immunogenicity and safety in 1,558 participants in the United States.
Yes. GSK Biologicals' Meningococcal vaccine GSK134612 is also known as Nimenrix. Searches for either name refer to the same GSK plc meningococcal vaccine candidate, which has been evaluated in two completed Phase 3 trials in healthy children and infants.