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OpenTrials
Completed

NCT Number: NCT02148874

Immune Responses to the Flu Shot During Pregnancy

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.

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Key information

Conditions

Pregnancy Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43220, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

influenza virus vaccination

Biological

comparison of immune responses to the flu vaccine in obese and non-obese populations

Other names: flu shot, influenza shot, flu vaccine

Primary outcomes

  1. Maternal HAI Antibody Titers

    Time frame: 30-days after influenza vaccination

    Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay

  2. Maternal HAI Antibody Titers

    Time frame: at delivery

    Maternal influenza antibody titers from hemagglutination inhibition (HAI) assay

Secondary outcomes

  1. Infant HAI Antibody Titers

    Time frame: cord blood at delivery

    Infant influenza antibody titers from hemagglutination inhibition (HAI) assay

Sponsors and collaborators

Lead sponsor

Lisa Christian

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
May 28, 2014
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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