MedTrace Logo

Influenza Vaccine Trial in HIV Uninfected Pregnant Women

NCT01306669 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2116

Last updated 2018-08-06

No results posted yet for this study

Summary

Randomised, double blind, placebo controlled trial to assess safety, immunogenicity and efficacy of Trivalent Influenza vaccine in HIV uninfected pregnant women

Conditions

Interventions

BIOLOGICAL

Trivalent influenza vaccine

single dose of 0.5ml of Trivalent influenza vaccine for season will be administered into deltoid muscle of non-dominant arm

BIOLOGICAL

Normal saline

Single dose of 0.5ml of normal saline will be administered into deltoid muscle of non-dominant arm

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Bill and Melinda Gates Foundation

    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 · University of 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
2011-03-03
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • South Africa

Study Locations

More Related Trials

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 NCT01306669 on ClinicalTrials.gov