CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 103 enrolled
Drug / intervention
Seasonal Inactivated Influenza Vaccinebiological
Likely dose
Seasonal Inactivated Influenza Vaccine 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01978262
NCT01978262Phase 4Completed
CompareCT.gov

A Pilot Study of the Immune Response to Influenza Vaccination and Effect on Reproductive Hormones

Johns Hopkins Bloomberg School of Public Health·interventional·Posted Nov 7, 2013·Updated Dec 27, 2018

In Brief

A Phase 4 clinical trial evaluating Seasonal Inactivated Influenza Vaccine for Healthy. Completed, enrolled 103 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
CollaboratorsCenters for Disease Control and Prevention

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 7, 2013
Enrollment StartOct 1, 2013
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 12.7 years ago

Interventions

Seasonal Inactivated Influenza Vaccinebiological

Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly