Immune Responses to the Flu Shot During Pregnancy

Lisa Christian

Status: Completed

Conditions: Pregnancy

Treatments: Biological: influenza virus vaccination

Study type: Observational

Funder types: Other

Identifiers

NCT02148874

2008H0260

Details and patient eligibility

About

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.

Enrollment: 287 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

287 participants in 1 patient group

Flu Shot

Description:

pregnant women receive a seasonal influenza virus vaccination

Treatment:

Biological: influenza virus vaccination