Two-site Intradermal Influenza Vaccination in Elderly
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Queen Saovabha Memorial Institute
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- immunogenicity
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
The subjects would be randomly divided into three groups of 60 subjects each. Group1 receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain, Group II receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group III receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site. Check for HA Antibody
Investigators
Suda Sibunruang
Principal investigator
Queen Saovabha Memorial Institute
Eligibility Criteria
Inclusion Criteria
- •healthy male or female volunteer aged at least 60 years old
- •willing to participate in this study
Exclusion Criteria
- •previous influenza vaccination within 6 months
- •systemic ypersensitivity to egg or chicken proteins or any of the vaccine components
- •history of a life-threatening reaction to the study vaccine or a vaccine containing the same constituents.
- •ongoing acute febrile illness (oral temperature, ≥37.5 c )
- •congenital or acquired immunodeficiency
- •treatment with immunosuppressive or other immune- modifying drugs or cancer therapy within previous 6 months
- •long-term treatment with systemic corticosteroids
- •receipt of blood or blood-derived products in the previous 3 months
- •history of thrombocytopenia or a bleeding disorder contraindicating for intramuscular vaccination.
Outcomes
Primary Outcomes
immunogenicity
Time Frame: 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
Secondary Outcomes
- safety(4 months)
- comparison of the immunogenicity(4 months)