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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00586612 | Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants | PHASE3 | COMPLETED | 313 | — | — | Dec 1, 2007 | Dec 30, 2008 | Aug 27, 2018 | 8 | Spain |
Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.
rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.
| Arm | Type | Description |
|---|---|---|
| Preterm group | EXPERIMENTAL | Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. |
| Full-term group | ACTIVE_COMPARATOR | Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age. |
| Name | Type | Description |
|---|---|---|
| Menitorix™ | BIOLOGICAL | Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study. |
| Infanrix™ penta | BIOLOGICAL | Intramuscular injection, 3 doses in the primary study |
| Prevenar™ | BIOLOGICAL | Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study. |
| Infanrix™ IPV | BIOLOGICAL | Intramuscular injection, 1 dose in the Booster study. |
Inclusion Criteria: All subjects must satisfy the following criteria at study entry: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 8 and 12 weeks of age at the time of the ...