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 an investigational vaccine used for the prevention of meningococcal infections. It is being developed for use in healthy adolescents, adults, and toddlers to provide protection against meningococcal disease. The vaccine is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
Meningococcal vaccine GSK134612 is being developed by Pfizer, Inc. (NYSE: PFE). The vaccine was originally developed by GlaxoSmithKline (GSK) Biologicals, as indicated in the clinical trial titles, but Pfizer is listed as the developer of the asset.
Meningococcal vaccine GSK134612 is in Phase 3 clinical development. All three clinical trials for the vaccine have been completed, with a total enrollment of 1,357 participants. The vaccine is investigational and has not been approved by the FDA or other regulatory agencies.
Meningococcal vaccine GSK134612 has been studied in three completed Phase 3 clinical trials: NCT01934140, NCT01939158, and NCT01962207. These trials evaluated the vaccine's immunogenicity, safety, and long-term antibody persistence in healthy adolescents, adults, and toddlers across multiple countries including the Philippines, Australia, Canada, Czechia, Panama, South Africa, Turkey, and Finland.
Yes, Meningococcal vaccine GSK134612 is also known as PF-06866681. In the clinical trial NCT01962207, the vaccine is referred to as MenACWY-TT Vaccine (PF-06866681), confirming that these names refer to the same investigational meningococcal vaccine.