MedTrace Logo

Safety of and Immune Response to an H1N1 Influenza Vaccine in HIV Infected Pregnant Women

NCT00992017 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-11-05

Study results available
· View outcomes & findings →

Summary

Both pregnant women and people infected with HIV are at increased risk of viral infection, including influenza infection. Pregnant women infected with HIV may be at particular risk of infection from the new H1N1 influenza virus. This study tested the safety and immunogenicity of an H1N1 influenza vaccine in pregnant women infected with HIV.

Conditions

  • HIV Infections
  • H1N1 Influenza Virus

Interventions

BIOLOGICAL

Influenza A (H1N1) monovalent vaccine

Two 15-microgram intramuscular vaccine injections given together form one dose; two doses (four total injections) are given 21 days apart

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sharon Nachman, MD · State University of New York at Stony Brook

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

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 NCT00992017 on ClinicalTrials.gov