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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01340898 | Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers | PHASE3 | COMPLETED | 753 | — | — | Jan 27, 2012 | Oct 19, 2015 | Aug 6, 2019 | 2 | Lebanon, Mexico |
The cut-off value for the rSBA titers was ≥ 1:8. Neisseria meningitidis serogroups A, C, W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) antibodies were assessed.
| Arm | Type | Description |
|---|---|---|
| Nimenrix 3+1 Group | EXPERIMENTAL | Subjects, male and female, received 4 doses of Nimenrix™ vaccine (3 doses at 2, 4 and 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
| Nimenrix 1+1 Group | EXPERIMENTAL | Subjects, male and female, received 2 doses of Nimenrix™ vaccine (1 dose at 6 months of age followed by a booster dose at 15-18 months of age) and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
| Nimenrix Control Group | EXPERIMENTAL | Subjects, male and female, received 1 dose of Nimenrix™ at 15-18 months of age and 4 doses of Synflorix™ and Infanrix-IPV/Hiberix™ vaccines (at 2, 4, 6 and 15-18 months of age). All vaccines were administered intramuscularly (IM) in the anterolateral region of the thigh. |
| Name | Type | Description |
|---|---|---|
| Meningococcal vaccine GSK 134612 | BIOLOGICAL | Intramuscular injection |
| SynflorixTM | BIOLOGICAL | Intramuscular injection |
| Infanrix-IPV/HiberixTM | BIOLOGICAL | Intramuscular injection |
Inclusion Criteria: * Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. * Written informed conse...