Influenza Vaccine (Split Virion), Inactivated, Quadrivalent in Pregnant Women
Recruiting
Phase 3
Interventional Study
Influenza
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 39
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 150 (estimated)
- Sponsor
- Sinovac Biotech Co., Ltd · Industry
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About This Trial
This is a randomized, double-blind, positive controlled phase Ⅲ clinical trial to assess the immunogenicity and safety of Sinovac QIV in pregnant women. A total of 150 healthy pregnant women aged 18\~39 years at 20 to 32 weeks of pregnancy will be enrolled. All participants will be randomized to test group and control group in a ratio of 2:1 and receive one dose of vaccine (0.5 mL) of Sinovac QIV …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Pregnant women aged 18 to 39 years in good health or medically stable.
2. Gestational age of 20 to 32 weeks, based on last menstrual period, early or late ultrasound dating.
3. The participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection according…
Contacts