Immune and Hormone Response to Influenza Vaccine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01978262|
Recruitment Status : Completed
First Posted : November 7, 2013
Results First Posted : October 11, 2018
Last Update Posted : December 27, 2018
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Biological: Seasonal Inactivated Influenza Vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||103 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of the Immune Response to Influenza Vaccination and Effect on Reproductive Hormones|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
All women are to receive the quadrivalent influenza vaccine
Biological: Seasonal Inactivated Influenza Vaccine
Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
Other Name: FluZone
- Change in Levels of Progesterone After Influenza Vaccination [ Time Frame: 2 months ]To explore whether receipt of IIV during the second week of the menstrual cycle (i.e., the week prior to ovulation) is associated with changes in steroid hormone levels, particularly decreases in progesterone, following ovulation.
- Cytokine Effect on Reproductive Hormone Levels [ Time Frame: 2 months ]To explore whether inflammatory cytokine responses to IIV receipt are associated with changes in reproductive and stress hormone levels.
- Cytokine Responses to Influenza Vaccine [ Time Frame: 2 days ]Identify optimal biomarkers of the inflammatory response after vaccination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978262
|United States, Maryland|
|Center for Immunization Research; Johns Hopkins Bloomberg School of Public Health|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Kawsar R Talaat, MD||Johns Hopkins Bloomberg School of Public Health|
|Principal Investigator:||Karen Broder, M.D.||Centers for Disease Control and Prevention|