NCT02562508

A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

Immunogenicity and Safety Study of a Bivalent Human Papillomavirus (Type 16, 18) Recombinant Vaccine (E.Coli) in Healthy Female Subjects Aged 9 to 17 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 979 (actual)
• Sponsor: Jun Zhang · Academic / Other
• Sex: Female
• Age: 9 Years – 26 Years
• Healthy volunteers: Accepted

Summary

This is a bridging trial of the recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD.The primary objective of this study is to evaluate the immunogenicity (type specific IgG antibody) and safety of the tested vaccine administered in girls aged 9-17 years is non-inferior to young healthy adults of 18-26 years according to the standard 3-dose schedule (0,1,6 months). Meanwhile, this study tries to compare the difference of safety and immunogenicity among different schedules (0-6m vs 0-1-6m).

Detailed description

Totally 750 healthy girls of 9-17 years and 225 healthy young women of 18-26 years were enrolled. The subjects of 9-14 years will be stratified into 2 subset. Subjects in each subsets will be randomly assigned into the standard 0-1-6m schedule group or an alternative 0-6m group. All subjects of 15-26 years of age will receive the standard 0-1-6m schedule. Participants were actively monitored for adverse events for 1 month after each injection. Severe adverse events during the trial were followed up. Serum samples from all the subjects would be collected on day 0, 6m, 7m to evaluate the immunogenicity.

Conditions

• Cervical Intraepithelial Neoplasia
• Cervical Cancer
• Vaginal Intraepithelial Neoplasia
• Vulvar Intraepithelial Neoplasia
• Persistent Infection

Interventions

Type	Name	Description
PROCEDURE	3 doses of HPV 16/18 bivalent vaccine	Participants would receive 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
PROCEDURE	2 doses of HPV 16/18 bivalent vaccine	Participants would receive 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)

Timeline

• Start date: 2015-12-05
• Primary completion: 2016-08-12
• Completion: 2016-08-12
• First posted: 2015-09-29
• Last updated: 2018-08-16

Locations

1 site across 1 country: China