Approval Probability
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ML Risk
Meningococcal vaccine GSK 134612 · 1 trial · 1 indication
The cut-off value for the rSBA titers was ≥ 1:8. Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed.
| Arm | Type | Description |
|---|---|---|
| Nimenrix 3+1 Group | EXPERIMENTAL | Subjects, male and female, received 4 doses of Nimenrix™ vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
| Nimenrix 1+1 Group | EXPERIMENTAL | Subjects, male and female, received 2 doses of Nimenrix™ vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
| Nimenrix Control Group | EXPERIMENTAL | Subjects, male and female, received 1 dose of Nimenrix™ at 15-18 months of age and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
| Name | Type | Description |
|---|---|---|
| Meningococcal vaccine GSK 134612 | BIOLOGICAL | Intramuscular injection |
| SynflorixTM | BIOLOGICAL | Intramuscular injection |
| Infanrix-IPV/HiberixTM | BIOLOGICAL | Intramuscular injection |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. * Written informed conse...
Meningococcal vaccine GSK 134612 is an investigational vaccine being developed for the prevention of meningococcal infections. It is intended for use in healthy individuals, including toddlers, children, adolescents, and adults, to protect against diseases caused by Neisseria meningitidis bacteria.
Meningococcal vaccine GSK 134612 is being developed by GSK plc, a global biopharma company traded on the London Stock Exchange under the ticker GSK. The company has conducted multiple clinical trials to evaluate the vaccine's immunogenicity and safety across various age groups.
Meningococcal vaccine GSK 134612 is currently in Phase 3 clinical development. It remains an investigational vaccine and has not been approved by regulatory authorities. The development program includes completed Phase 2 trials that have informed the design of later-stage studies.
Meningococcal vaccine GSK 134612 has been studied in 14 completed clinical trials with a total enrollment of 9,409 participants. Notable trials include NCT00471081 in toddlers, NCT00661557 in previously vaccinated subjects, NCT00718666 for long-term antibody persistence, and NCT01165242 comparing it to Menactra in adolescents and adults.
No, Meningococcal vaccine GSK 134612 is not the same as Menactra. Menactra is a licensed meningococcal conjugate vaccine used as an active comparator in clinical trials. In study NCT01165242, GSK 134612 was directly compared against Menactra to evaluate its immunogenicity and safety profile.