NCT01812980

Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV-infected Women

Immunogenicity and Safety of Trivalent Influenza Vaccine in Non-pregnant HIV- Infected Women: An Open Label Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: University of Witwatersrand, South Africa · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this project is to evaluate the immunogenicity of TIV vaccination in HIV-infected non-pregnant women in 2013. Safety data including solicited local and systemic reactions to the vaccine will also be assessed.

Detailed description

Schedule of Events Visit 1 (enrollment) Informed Consent Form (ICF) signed Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw TIV administered Diary card dispensed Local/ systematic reactions Visit 2: 1 month post enrolment (28-35 days) Inclusion/ exclusion/ Withdrawal criteria Medical history Targeted physical exam Blood draw Diary card collected Local/ systematic reactions reviewed

Conditions

• Influenza
• Human Immunodeficiency Virus

Interventions

Type	Name	Description
BIOLOGICAL	Trivalent Inactivated Influenza Vaccine	WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains: * an A/California/7/2009 (H1N1)pdm09-like virus; * an A/Victoria/361/2011 (H3N2)-like virus; - a B/Wisconsin/1/2010-like virus.

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-03-18
• Last updated: 2013-12-11

Locations

1 site across 1 country: South Africa