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.
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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

April Rose T. Nepomuceno

+63 9328484020

april.nepomuceno@gmail.com

CONTACT