NCT01202552

Two-site Intradermal Influenza Vaccination in Elderly

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Queen Saovabha Memorial Institute · Academic / Other
• Sex: All
• Age: 60 Years – 100 Years
• Healthy volunteers: Accepted

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

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	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
BIOLOGICAL	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 and group
BIOLOGICAL	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

Timeline

• Start date: 2010-10-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2010-09-16
• Last updated: 2018-04-06

Locations

1 site across 1 country: Thailand