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Clinical Trials/NCT02148874
NCT02148874
Completed
Not Applicable

Immune Responses to the Flu Shot During Pregnancy

Lisa Christian1 site in 1 country287 target enrollmentOctober 2013
ConditionsPregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Lisa Christian
Enrollment
287
Locations
1
Primary Endpoint
Maternal HAI Antibody Titers
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study will examine effects of everyday life stress and obesity on immune responses to influenza virus vaccine (the flu shot) during pregnancy. Following vaccination, antibody levels against influenza (the flu) increase. Higher antibody levels indicate better immune protection from influenza. In addition to providing protection from the flu for yourself, being vaccinated during pregnancy may protect your baby from the flu during the first six months of life during which time infants cannot be vaccinated. Our primary goals are to determine whether greater life stress and obesity reduce 1) antibody responses to the flu shot in women and 2) antibody levels in the newborn at the time of delivery.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
August 2019
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Lisa Christian
Responsible Party
Sponsor Investigator
Principal Investigator

Lisa Christian

Assistant Professor

Ohio State University

Eligibility Criteria

Inclusion Criteria

  • less than 29 weeks pregnant
  • ages 18-42
  • planning to deliver at The Ohio State University Wexner Medical Center

Exclusion Criteria

  • prior serious adverse reaction to seasonal influenza vaccine

Outcomes

Primary Outcomes

Maternal HAI Antibody Titers

Time Frame: at delivery

Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay

Secondary Outcomes

  • Infant HAI Antibody Titers(cord blood at delivery)

Study Sites (1)

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