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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01777308 | Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination | PHASE3 | COMPLETED | 156 | — | — | May 3, 2013 | Apr 20, 2016 | Jan 25, 2019 | 8 | Australia |
Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
| Arm | Type | Description |
|---|---|---|
| Menitorix Group | EXPERIMENTAL | Subjects who were primed with Menitorix™ (Hib-MenC-TT) + Priorix™ (MMR) vaccines in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1). The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| Meningitec + Hiberix Group | EXPERIMENTAL | Subjects who were primed with Meningitec™ (MCC) + Hiberix™ (Hib) + Priorix™ (MMR) vaccine in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1). The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm. |
| Name | Type | Description |
|---|---|---|
| Meningococcal conjugate vaccine GSK134612 | BIOLOGICAL | Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm |
Inclusion Criteria: * Subjects' parent(s)/Legally Acceptable Representative(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * A male or female between, and including, 84 and 95 months of age at the time of the booster vaccination. * Written in...