Status:
COMPLETED
Surveillance Study to Assess the Safety of Flublok Quadrivalent (Influenza Vaccine) in Pregnant Women and Their Offspring
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Eligibility:
All Genders
Up to 64 years
Brief Summary
Primary Objective: To evaluate the safety of Flublok Quadrivalent influenza vaccine in pregnant women included in the VAP00003 Study (NCT03694392) and their offspring exposed during pregnancy or up t...
Detailed Description
Data will be recorded prospectively during the safety follow-up for pregnant women until delivery (or pregnancy outcome, whichever is later), and for infants of pregnant women for 1 year after birth.
Eligibility Criteria
Inclusion
- Inclusion criteria
- Pregnant women:
- Laboratory or medical professional confirmation of pregnancy
- Exposure to either Flublok Quadrivalent influenza vaccine or standard-dose quadrivalent inactivated influenza vaccine (SD-IIV4) in the VAP00003 Study during pregnancy or within 28 days preceding conception
- Offspring:
- Infants delivered by pregnant women who satisfy the criteria above Exclusion criteria
- Documented receipt of any other influenza vaccine at any other time during the pregnancy
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
September 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
96175 Patients enrolled
Trial Details
Trial ID
NCT04460781
Start Date
September 17 2018
End Date
February 28 2022
Last Update
May 24 2022
Active Locations (1)
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1
Kaiser Permanente Northern California
Oakland, California, United States, 94612