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Field Trial of Maternal Influenza Immunization in Asia

NCT01034254 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3693

Last updated 2022-02-01

No results posted yet for this study

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.

Conditions

  • Influenza Human

Interventions

BIOLOGICAL

influenza vaccine

Pregnant women will receive FDA approved influenza vaccine.

BIOLOGICAL

saline placebo

Vaccination of pregnant women with saline placebo.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Seattle Children's Hospital

    collaborator OTHER

  • Tribhuvan University, Nepal

    collaborator OTHER

  • Johns Hopkins Bloomberg School of Public Health

    collaborator OTHER

  • Thrasher Research Fund

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Mark C Steinhoff, MD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2014-05-31
Completion
2017-10-31

Countries

  • Nepal

Study Locations

More Related Trials

Entities

Drugs

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 NCT01034254 on ClinicalTrials.gov