N/A
Completed N=287
Immune Responses to the Flu Shot During Pregnancy
Source: ClinicalTrials.gov NCT02148874 ↗Enrolled (actual)
287
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Maternal HAI Antibody Titers — 55.9; 59.8; 78.5; 74.0 Titer — p=0.84
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal HAI Antibody Titers |
23.5; 32.5; 31.6; 32.7; 10.3; 16.3 | 0.20 |
| PRIMARY Maternal HAI Antibody Titers |
23.5; 32.5; 31.6; 32.7; 10.3; 16.3 | 0.20 |
| SECONDARY Infant HAI Antibody Titers |
95.4; 78.4; 155.5; 118.2; 139.0; 157.0 | 0.64 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02148874). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.