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Influenza Vaccination of HIV Infected Pregnant Women: Safety and Immunogenicity

NCT01306682 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2013-02-07

No results posted yet for this study

Summary

This randomized, placebo controlled trial will evaluate the safety and immunogenicity of Trivalent Influenza Vaccine (TIV) in HIV-infected pregnant women, dynamics of transplacental anti-influenza antibody transfer to their newborns and kinetics thereof during early infancy.

Conditions

Interventions

BIOLOGICAL

Trivalent influenza vaccine

0.5 ml of trivalent influenza vaccine administered into deltoid muscle of non dominant arm

BIOLOGICAL

Normal saline

0.5ml normal saline administered into deltoid muscle of non dominant arm

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • University of Witwatersrand, South Africa

    lead OTHER

Principal Investigators

  • Shabir A Madhi, MD, PhD · University of Witwatersrand, South Africa

  • Keith P Klugman, MD, PhD · Emory University

  • Adriana Weinberg, PhD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-06-30
Completion
2012-07-31

Countries

  • South Africa

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01306682 on ClinicalTrials.gov