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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00242424 | Safety and Immunogenicity of Inactivated Influenza Virus Vaccine Among Healthy Children 6-12 Weeks of Age | PHASE2 | COMPLETED | 1,375 | — | — | Sep 1, 2005 | Sep 1, 2007 | Jan 28, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | 0.25 ml normal saline placebo given as injection to infants at 2 and 3 months of age |
| 2 | EXPERIMENTAL | 2005-6 Fluzone, pediatric formulation of trivalent inactivated influenza vaccine (sanofi pasteur) administered to infants at 2 and 3 months of age |
| Name | Type | Description |
|---|---|---|
| 2005-2006 trivalent inactivated influenza vaccine | BIOLOGICAL | Children enrolled at 6-12 weeks to receive first dose, 0.25 ml of trivalent inactivated influenza vaccine, 2005-6 pediatric Fluzone formulation (sanofi pastuer), with concomitant routine pediatric vaccines. Second dose administered 4 weeks later. |
Inclusion Criteria: * Age 42 to 84 days on the day of inclusion * Full term (born at \>=36 weeks with birth weight \>=2.5 kg * Considered to be in good health * Parental consent obtained and available * Available for the study duration (6 months) Exclusion Criteria: * Reported allergy to egg prot...