Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Meningococcal vaccine GSK134612 · 3 trials · 1 indication
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY).
Serogroups included MenA, MenC, MenW-135 and MenY.
Serogroups included MenA, MenC, MenW-135 and MenY.
Serogroups included MenA, MenC, MenW-135 and MenY.
Serogroups included MenA, MenC, MenW-135 and MenY.
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units.
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present with a medical condition or received product leading to exclusion or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \>=1:8 and \>=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.
GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per milliliter (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2 (Month 1), and had available blood sample at Visit 2 (Month 1) for PCV13 group.
Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY).
Serogroups included MenA, MenC, MenW-135 and MenY.
Serogroups included MenA, MenC, MenW-135 and MenY.
Serogroups included MenA, MenC, MenW-135 and MenY.
Serogroups included MenA, MenC, MenW-135 and MenY.
Serogroups included MenA, MenC, MenW-135 and MenY.
| Arm | Type | Description |
|---|---|---|
| ACWY-TT group | EXPERIMENTAL | All subjects vaccinated with MenACWY-TT in study MENACWY-TT-015 will be assigned to this group. At Month 120 after primary vaccination, these subjects will be vaccinated with a booster dose of MenACWY-TT in this study. |
| MenPS group | ACTIVE_COMPARATOR | All subjects vaccinated with Mencevax ACWY in study MENACWY-TT-015 will be assigned to this group. At Month 120 after primary vaccination, these subjects will be vaccinated with a dose of MenACWY-TT in this study. |
| ACWY1d group | EXPERIMENTAL | Subjects will receive 1 dose of the MenACWY-TT vaccine |
| ACWY2d group | EXPERIMENTAL | Subjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart |
| Co-ad group | EXPERIMENTAL | Subjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13™ |
| PCV-13 group | ACTIVE_COMPARATOR | Subjects will receive 1 dose of Prevenar 13™ and 1 dose of the MenACWY-TT vaccine 2 months later |
| ACWY<2 Group | EXPERIMENTAL | Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT. |
| ACWY≥2 Group | EXPERIMENTAL | Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT. |
| MenCCRM Group | EXPERIMENTAL | Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Meningitec. |
| Name | Type | Description |
|---|---|---|
| Meningococcal vaccine GSK134612 | BIOLOGICAL | 1 dose administered intramuscularly in the non-dominant deltoid region. |
| Prevenar 13™ | BIOLOGICAL | 1 dose administered intramuscularly in the right anterolateral thigh or deltoid region |
Inclusion Criteria: All subjects must satisfy the following criteria at study entry to the persistence phase: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Or /and subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] w...
Meningococcal vaccine GSK134612 is a vaccine being developed for the prevention of meningococcal infections. It is designed to protect against Neisseria meningitidis, the bacterium that causes meningococcal disease, including meningitis and bloodstream infections. The vaccine is in Phase 3 clinical development.
Meningococcal vaccine GSK134612 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The vaccine originated from GlaxoSmithKline Biologicals, as indicated by the GSK identifier in its name, and is now part of Pfizer's meningococcal vaccine program.
Meningococcal vaccine GSK134612 is in Phase 3 clinical development. Three Phase 3 trials have been completed, and no active trials are currently listed. The vaccine has not been approved by the FDA and remains investigational.
Meningococcal vaccine GSK134612 has been evaluated in three completed Phase 3 trials: NCT01962207 in Finland, NCT01939158 in Australia, Canada, Czechia, Panama, South Africa, and Turkey, and NCT01934140 in the Philippines. These trials enrolled a total of 1,357 participants.
Yes, Meningococcal vaccine GSK134612 is also known as MenACWY-TT and PF-06866681. These names refer to the same vaccine candidate developed for protection against meningococcal serogroups A, C, W, and Y.