drugset / Trial / NCT01215669
Study of Sanofi Pasteur's Intradermal Influenza Vaccine (IDflu™) in Adults and Elderly in Korea
RandomizedParallel-groupOpen-labelPrevention
Summary
This study is designed to assess the immunogenicity and safety of the 2010-2011 NH season formulation of intradermal (ID) influenza vaccine as part of a post registration commitment. Objectives: * For all groups, to evaluate compliance, in terms of immunogenicity, of the corresponding strength of the intradermal (ID) or intramuscular (IM) influenza vaccine Northern Hemisphere (NH) 2010 2011 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 * For all groups, to describe the safety
Timeline
- Start
- 2010-10
- Primary completion
- 2011-02
- Completion
- 2011-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IDflu | Vaccine | 0.1 ml | Intravenous |
| Comparator | Influenza Virus Vaccine | Vaccine | 0.5 ml | Intramuscular |