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Immune and Hormone Response to Influenza Vaccine

NCT01978262 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2018-12-27

Study results available
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Summary

The purpose of this pilot research project is to look at the effect of the inactivated influenza vaccine (seasonal flu shot) on early signs of immune or germ-fighting response known as cytokines or signal molecules. The investigators also want to see if the timing of vaccine administration has any effect on women's reproductive hormones. The investigators hypothesis is that influenza vaccine given right before ovulation may change the hormone levels usually seen after ovulation. Thi

Conditions

  • Healthy

Interventions

BIOLOGICAL

Seasonal Inactivated Influenza Vaccine

Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly

Sponsors & Collaborators

Principal Investigators

  • Kawsar R Talaat, MD · Johns Hopkins Bloomberg School of Public Health

  • Karen Broder, M.D. · Centers for Disease Control and Prevention

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01978262 on ClinicalTrials.gov