A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years

Recruiting Phase 3 Interventional Study
HPV InfectioN HPV-Related Carcinoma
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 – 45
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
13,500 (estimated)
Sponsor
National Vaccine and Serum Institute, China · Industry
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About This Trial

A total of 13500 Chinese women aged 18-45 years old were divided into three age groups: 18-26 years old, 27-35 years old, and 35-45 years old. The experimental group and the placebo group were randomly assigned in a ratio of 1:1. All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test vaccine or placebo according to the 0, 2, and 6 months immunization program.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: \- non-gynecological related 1. \*Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification; 2. \*Axillary body temperature \<37.3℃ on the day of enrollment; 3. The subjects themselves have the ability to …
Contacts

Zhaojun Mo

(+86)15177771508

mozhj@126.com

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