CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 130 enrolled
Drug / intervention
Influenza A (H1N1) monovalent vaccinebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00992017
NCT00992017Phase 2Completed
CompareCT.gov

A Phase II Study to Assess the Safety and Immunogenicity of an Inactivated Monovalent Influenza A (H1N1) Vaccine in HIV-1 Infected Pregnant Women

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Oct 8, 2009·Updated Nov 5, 2021

In Brief

A Phase 2 clinical trial evaluating Influenza A (H1N1) monovalent vaccine for HIV Infections and H1N1 Influenza Virus. Completed, enrolled 130 participants across 31 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections, H1N1 Influenza Virus
CountriesPuerto Rico, United States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 8, 2009
Enrollment StartOct 1, 2009
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.7 years ago

Interventions

Influenza A (H1N1) monovalent vaccinebiological

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