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Two-site Intradermal Influenza Vaccination in Elderly
One-site dose sparing intradermal influenza vaccination in elderly had been studied but resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age. An influenza vaccine administered intramuscularly at the standard dose is used as the reference vaccine.
Details
| Lead sponsor | Queen Saovabha Memorial Institute |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 180 |
| Start date | 2010-10 |
| Completion | 2018-04 |
Conditions
- Influenza
Interventions
- seasonal influenza vaccine
- seasonal influenza vaccine
- seasonal influenza vaccine
Primary outcomes
- immunogenicity — 4 months
evaluate the immunogenicity of the two-site intradermal influenza vaccination containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age , as measured by the titer of hemagglutination inhibition (HAI) antibodies, in order to determine whether it would meet the guidelines of the European Committee for Proprietary Medicinal Products (CPMP) for the annual relicensure of influenza vaccines
Countries
Thailand