drugset / Trial / NCT01407978
Tolerability and Immunogenicity Study of FLUVAL P H1N1 Flu Vaccine of Omninvest in Children and Adolescents
RandomizedParallel-groupSingle-blindPrevention
Summary
This is a single-blind, reference drug controlled study to assess safety and tolerability of FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children and adolescents. To assess, as secondary objective, the efficacy (immunogenicity) of the vaccine by serology testing.
Timeline
- Start
- 2009-08
- Primary completion
- 2010-03
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluval AB | Vaccine | 0.25 ml | — |
| Comparator | Fluval AB | Vaccine | 0.5 ml | — |
| Comparator | Fluval AB Novo | Vaccine | 0.25 ml | — |
| Comparator | Fluval AB Novo | Vaccine | 0.5 ml | — |
| Subject | Fluval P | Vaccine | 0.25 ml | — |
| Subject | Fluval P | Vaccine | 0.5 ml | — |