Immune Responses to the Flu Shot During Pregnancy

Completed

• Conditions: Pregnancy
• Interventions: Biological: influenza virus vaccination

• Registration Number: NCT02148874
• Lead Sponsor: Lisa Christian

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-28
• Primary Completion: 2017-05
• Results First Submitted: 2019-07-18
• Results First Submitted QC: 2019-07-18
• Study Completion: 2019-08
• Results First Posted: 2019-08-28
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 287

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Flu Shot	influenza virus vaccination	pregnant women receive a seasonal influenza virus vaccination

Primary Outcome Measures

Name	Time	Method
Maternal HAI Antibody Titers	at delivery	Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay

Secondary Outcome Measures

Name	Time	Method
Infant HAI Antibody Titers	cord blood at delivery	Infant influenza antibody titers from hemagglutination inhibition (HAI) assay

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States