Randomized Controlled Trial to Compare the Immunogenicity of Intramuscular Versus Intradermal Trivalent Inactivated Split Virion Influenza Vaccine in HIV-infected Men Who Have Sex With Men in Bangkok, Thailand

NCT01538940 Phase 4 COMPLETED

This study will assess the efficacy of a new intradermal formulation of the trivalent inactivated influenza vaccine compared to the standard intramuscular vaccine in HIV-infected men who have sex with men in Bangkok, Thailand. Relative efficacy of the two different formulations of influenza vaccine will be assessed by comparing immunologic responses to vaccine between the two study arms.

Details

Lead sponsor	Centers for Disease Control and Prevention
Phase	Phase 4
Status	COMPLETED
Enrolment	415
Start date	2011-11-01
Completion	2015-10

Conditions

• Influenza

Interventions

• Intradermal vaccine
• Intramuscular vaccine

Primary outcomes

• Antibody titers — 30 days
  Frequency of 4-fold or greater increase in serum hemagglutination inhibition antibody titers against each viral strain in the vaccine

Countries

Thailand