Immune Responses to the Flu Shot During Pregnancy

NCT ID: NCT02148874

Last Updated: 2019-09-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

287 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Flu Shot

pregnant women receive a seasonal influenza virus vaccination

influenza virus vaccination

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

influenza virus vaccination

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

flu shot influenza shot flu vaccine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lisa Christian

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lisa Christian

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lisa M. Christian, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Christian LM, Beverly C, Mitchell AM, Karlsson E, Porter K, Schultz-Cherry S, Ramilo O. Effects of prior influenza virus vaccination on maternal antibody responses: Implications for achieving protection in the newborns. Vaccine. 2017 Sep 18;35(39):5283-5290. doi: 10.1016/j.vaccine.2017.05.050. Epub 2017 Aug 1.

Reference Type DERIVED
PMID: 28778612 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2008H0260

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.