Two-site Intradermal Influenza Vaccination in Elderly

Not Applicable

Completed

• Conditions: Influenza
• Interventions: Biological: seasonal influenza vaccine

• Registration Number: NCT01202552
• Lead Sponsor: Queen Saovabha Memorial Institute

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

Study Timeline

• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Study Start: 2010-10
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	seasonal influenza vaccine	receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site
group 1	seasonal influenza vaccine	receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain
group 3	seasonal influenza vaccine	receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
safety	4 months	evaluate for number of participants with adverse effects: * systemic effects such as fever, headache, myalgia; * local effects such as redness, swelling, induration and pain by giving diary card for each participant to record the data once daily for 1 week. (the investigators explain how to grade the redness (no/yes), swelling by measure, induration by measure, pain (no/yes))
comparison of the immunogenicity	4 months	comparison of the immunogenicity of the two-site influenza vaccine administered intradermally as the above reduced dose with those of the reference influenza vaccine administered intramuscularly at the standard dose

Trial Locations

Locations (1)

Queen Saovabha Memorial Institute; 🇹🇭 Bangkok, Thailand