Response to Influenza Vaccine During Pregnancy (FLU-PG)
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|ClinicalTrials.gov Identifier: NCT03888989|
Recruitment Status : Not yet recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Quadrivalent inactivated influenza vaccine (IIV)||Phase 4|
This is a Phase IV study of licensed influenza vaccines with up to 50 pregnant female volunteers, 18-49 years of age. Investigator intends to collect blood from pregnant women and then from the same women a year later when they are not pregnant after routine seasonal influenza vaccination. By studying the blood of immunized pregnant women and in these same women after pregnancy, the investigator will gain a better understanding of the immune response to vaccination in pregnancy and after pregnancy.
Each volunteer will participate for approximately 4 weeks including enrollment, vaccination, and completion of sample collection in 2 consecutive flu seasons. The Study has a total of 6 visits over 2 Flu seasons.
First Visit: Procedures during this visit are: Informed consent process, enrollment, study assessments, 20 ml blood draw, and vaccination.
2nd and 3rd visits: 20 ml blood will be obtained
First Visit: Study assessments, 20 ml blood draw, and vaccination. 2nd and 3rd visits: 20 ml blood will be obtained
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Response to Influenza Vaccine During Pregnancy|
|Estimated Study Start Date :||June 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Participants will be given the current year's quadrivalent inactivated influenza vaccine (IIV)
Biological: Quadrivalent inactivated influenza vaccine (IIV)
Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection
- Plasma HAI titer at Day 7 (year 1) [ Time Frame: Day 7 (year 1) ]HAI titer measures immune response to influenza vaccination
- Number of Participants With Related Adverse Events (year 1) [ Time Frame: Day 28 (Year 1) ]AEs to IIV
- Number of Participants With Related Adverse Events (Year 2) [ Time Frame: Day 28 (Year 2) ]AEs to IIV
- Plasma HAI titer at Day 7 (Year 2) [ Time Frame: Day 7 (Year 2) ]HAI titer measures immune response to influenza 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): NCT03888989
|Contact: Philip Grantfirstname.lastname@example.org|