Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children
Summary
A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.
Timeline
- Start
- 2009-10
- Primary completion
- 2010-01
- Completion
- 2010-01
Outcome
Mixed primary results
registry analysis (non-inferiority or equivalence test); Inflexal V 0.5 mL vs Agrippal 0.25 mL; p = 0.0036; Difference in seroconversion rates 4.5 (95% CI 1.4 to 7.5) NCT01310400 ↗
registry analysis (non-inferiority or equivalence test); Inflexal V 0.25 mL vs Agrippal 0.25 mL; p = 0.1465; Difference in seroconversion rates -3.0 (95% CI -7.0 to 1.0) NCT01310400 ↗
registry analysis (non-inferiority or equivalence test); Inflexal V 0.25 mL vs Agrippal 0.25 mL; p = 0.0029; Difference in seroconversion rates 10.7 (95% CI 3.7 to 17.6) NCT01310400 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Agrippal | Vaccine | 0.25 ml | Intramuscular |
| Subject | Inflexal V | Vaccine | 0.25 ml | Intramuscular |
| Subject | Inflexal V | Vaccine | 0.5 ml | Intramuscular |