NCT03206255

Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls

Immuno-persistence 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: —
• Study type: Observational
• Enrollment: 940 (actual)
• Sponsor: Jun Zhang · Academic / Other
• Sex: Female
• Age: 10 Years – 28 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years ,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

Detailed description

This is a follow-up study which is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) .We will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 18 and 30 months after dose 1.

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 have received 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 have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)

Timeline

• Start date: 2017-07-01
• Primary completion: 2018-08-15
• Completion: 2018-08-15
• First posted: 2017-07-02
• Last updated: 2019-01-04

Locations

1 site across 1 country: China