Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03189745 | A Study To Evaluate A Booster Dose Of Menacwy-tt Vaccine Administered 10 Years After Healthy Subjects Aged 11-17 Years Received Either Menacwy-tt Vaccine (Nimenrix(Registered)) Or Mencevax Acwy(Registered). | PHASE3 | COMPLETED | 229 | — | — | Aug 1, 2017 | Apr 11, 2018 | Oct 12, 2020 | 1 | Philippines |
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). The rSBA titer levels greater than or equal to (\>=) 1:32 for initially seronegative participants and at least four-fold increase in rSBA titer levels for initially seropositive participants, 1 month after booster vaccination were defined as booster response to meningococcal antigens and reported in this outcome measure. Initially seronegative participants were defined as participants with pre-vaccination rSBA titer levels below 1:8 and initially seropositive participants were defined as participants with pre-vaccination rSBA titer \>=1:8. Data reported below is including both seropositive and seronegative participants.
| Arm | Type | Description |
|---|---|---|
| MenACWY-TT Booster | EXPERIMENTAL | 10 year booster dose of MenACWY |
| Name | Type | Description |
|---|---|---|
| MenACWY-TT | BIOLOGICAL | Single dose of MenACWY-TT given 10 years after first vaccine with either MenACWY-TT or Mencevax ACWY |
Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits). * Written informed consent obtained from the subject prior to performing any study specific procedure...