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NCT02148874 Clinical Trial

Immune Responses to the Flu Shot During Pregnancy

Pregnancy Clinical Trial

Official title:
Immune Responses to the Flu Shot During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02148874
Other study ID # 2008H0260
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2013
Est. completion date August 2019

Study information
Verified date September 2019
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 287
Est. completion date August 2019
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 42 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• influenza virus vaccination
comparison of immune responses to the flu vaccine in obese and non-obese populations

Locations
Country Name City State
United States The Ohio State University Wexner Medical Center Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Lisa Christian

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maternal HAI Antibody Titers Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay 30-days after influenza vaccination
Primary Maternal HAI Antibody Titers Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay at delivery
Secondary Infant HAI Antibody Titers Infant influenza antibody titers from hemagglutination inhibition (HAI) assay cord blood at delivery
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