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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00258856 | Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune® | PHASE2 | COMPLETED | 234 | — | — | Jan 1, 2006 | Nov 1, 2007 | Feb 14, 2014 | 11 | United States |
Groups 1 and 2 received booster vaccination; Groups 3 and 4 received primary vaccination. Serum bactericidal activity for the Menactra® meningococcal serogroups A, C, Y, and W-135 were at pre-vaccination for all Groups, and at 7 days (Groups 1 and 3), and 14 days (Groups 2 and 4) post-vaccination.
| Arm | Type | Description |
|---|---|---|
| Menactra® Group 1 | EXPERIMENTAL | Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 3 and Day 7 after booster vaccination. |
| Menactra® Group 2 | EXPERIMENTAL | Participants who had received Menactra® in Study 603-02. They will provide serum sample before vaccination and on Day 5 and Day 14 after booster vaccination. |
| Meningococcal Vaccine-naïve Group 3 | EXPERIMENTAL | Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination. |
| Meningococcal Vaccine-naïve Group 4 | EXPERIMENTAL | Participants who have never received a Meningococcal vaccine in the past. They will provide serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination. |
| Name | Type | Description |
|---|---|---|
| Polysaccharide Diphtheria Conjugate Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: * Subject is healthy, as determined by medical history. * Subject is between the ages of 7 and 15 years (not yet 16 years). * For subjects who participated in Study 603-02, subject previously received one dose of Menactra® vaccine or Menomune®-A/C/Y/W-135 vaccine. * The date of ...