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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00443846 | RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016) | PHASE3 | COMPLETED | 247 | — | — | Feb 13, 2007 | Oct 23, 2007 | Jun 20, 2018 | - | — |
Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer \>=1:8.
| Arm | Type | Description |
|---|---|---|
| Group 1: Concomitant Administration | EXPERIMENTAL | Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age). |
| Group 2: Sequential Administration | ACTIVE_COMPARATOR | Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age. |
| Name | Type | Description |
|---|---|---|
| RotaTeq® | BIOLOGICAL | Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration. |
| NeisVac-C® | BIOLOGICAL | Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection. |
Inclusion Criteria: * Healthy infants, aged from 6 weeks through full 7 weeks, * Consent form signed by at least one parent or by the legal representative properly informed about the study, * Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card...