Immunogenicity and safety of high-dose versus standard-dose quadrivalent inactivated influenza vaccine in patients living with HIV: A randomized control trial

Phase 3

Completed

• Conditions: Patients living with HIV; HIV, immunocompromised, CD4 count

• Registration Number: TCTR20230501002
• Lead Sponsor: Faculty of Medicine Ramathibodi Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study Completion: 2023-10-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients living with HIV (age > 15 years old) who have been on antiretroviral therapy for 3 months regardless of their CD4 count

Exclusion Criteria

Patients living with HIV (age > 15 years old) who receive influenza vaccination within 6 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity 4 weeks Haeagglutination inhibition titer

Secondary Outcome Measures

Name	Time	Method
Safety 3 and 7 days Adverse reactions both local and systemic