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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...
GSK134612 is an investigational meningococcal vaccine being developed by GSK plc for the prevention of meningococcal infections. It is currently in Phase 3 clinical development. The vaccine is designed for use in healthy children, with a completed trial evaluating it in children aged 2 years and older.
GSK134612 is a meningococcal vaccine, meaning it is designed to elicit an immune response against Neisseria meningitidis, the bacterium that causes meningococcal disease. It is being studied for its ability to protect against meningococcal infections, which can cause meningitis and septicemia.
GSK134612 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 3 clinical development for the prevention of meningococcal infections.
GSK134612 is in Phase 3 clinical development. It is an investigational meningococcal vaccine, meaning it has not yet been approved by regulatory authorities. A Phase 3 trial has been completed, evaluating the vaccine in healthy children aged 2 years and older.
GSK134612 has one completed Phase 3 clinical trial, registered as NCT00674583. This trial, titled 'Comparison of GSK Biologicals' Meningococcal Vaccine (GSK134612) and Licensed MenC-CRM197 Vaccine in Healthy Children,' enrolled 414 participants in France and Germany. The study was active-controlled and randomized, comparing GSK134612 to a licensed meningococcal vaccine.
No, GSK134612 is not the same as the MenC-CRM197 vaccine. In the Phase 3 clinical trial NCT00674583, GSK134612 was compared against a licensed MenC-CRM197 vaccine as an active control. GSK134612 is an investigational meningococcal vaccine being developed by GSK plc, while MenC-CRM197 is a licensed comparator vaccine.