Clinical Trials Directory

Trials / Completed

CompletedNCT03900572

A Study of Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine

A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Immunogenicity of a 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Pichia Pastoris) in 9 to 45 Year Old Chinese Females

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Shanghai Zerun Biotechnology Co.,Ltd · Industry
Sex
Female
Age
9 Years – 45 Years
Healthy volunteers
Accepted

Summary

A randomized, double-blind and placebo-controlled phase I study to evaluate the safety and immunogenicity of a 9-valent Human Papillomavirus (HPV) vaccine, administered intramuscularly according to a 0, 2, 6-month schedule in 9 to 45 years old healthy Chinese females.

Conditions

Interventions

TypeNameDescription
BIOLOGICALHPV VaccineIntramuscular injection, 3 doses
DRUGPlaceboIntramuscular injection, 3 doses

Timeline

Start date
2019-03-09
Primary completion
2020-04-30
Completion
2020-04-30
First posted
2019-04-03
Last updated
2023-04-13

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT03900572. Inclusion in this directory is not an endorsement.