CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,693 enrolled
Drug / intervention
influenza vaccine +1 morebiological
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/NCT01034254
NCT01034254Phase 3Completed
CompareCT.gov

Field Trial of Maternal Influenza Immunization in Asia

Children's Hospital Medical Center, Cincinnati·interventional·Posted Dec 17, 2009·Updated Feb 1, 2022

In Brief

A Phase 3 clinical trial evaluating influenza vaccine and saline placebo for Influenza Human. Completed, enrolled 3,693 participants across 1 site.

Detailed Summary

This project is designed to assess the efficacy of immunizing women during pregnancy with influenza vaccine on the health of these women during their pregnancy and for 6 months post-partum as well as on the health of their newborn infants during the first 6 months of life. It will be conducted in Sarlahi District in southern Nepal, a rural area where a number of large scale randomized trials have been conducted over the past 20 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza Human
CountriesNepal
CollaboratorsBill and Melinda Gates Foundation, Seattle Children's Hospital, Tribhuvan University, Nepal, Johns Hopkins Bloomberg School of Public Health, Thrasher Research Fund

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2009
Enrollment StartNov 1, 2010
Primary CompletionMay 1, 2014
Study CompletionOct 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.5 years ago

Interventions

influenza vaccinebiological

Pregnant women will receive FDA approved influenza vaccine.

saline placebobiological

Vaccination of pregnant women with saline placebo.