NCT02562508 - A Bridging Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls | Biotech Hunter

Enrollment

979

Participants

Timeline

Start Date

December 5, 2015

Primary Completion Date

August 12, 2016

Study Completion Date

August 12, 2016

Conditions

Cervical Intraepithelial NeoplasiaCervical CancerVaginal Intraepithelial NeoplasiaVulvar Intraepithelial NeoplasiaPersistent Infection

Interventions

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)

Trial Locations (1)

Jiangsu Provincial Centre for Disease Control and Prevention, Nanjing

All Listed Sponsors

collaborator

Xiamen Innovax Biotech Co., Ltd

INDUSTRY

collaborator

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

INDUSTRY

lead

Jun Zhang

OTHER