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Evaluating the 2-dose Immunization Schedule of Human Papillomavirus (HPV)-16/18 in Adolescent Females

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:
Immunogenicity Study of a 2-dose Immunization Schedule of Recombinant Human Papillomavirus Virus-like Particle Vaccine (Type 16 and 18 L1 Proteins, Yeast) in Adolescent Females Aged 9 to 14 Years

Clinical Trial Summary

To evaluate the immune non-inferiority, as measured by antibody responses, of a 2-dose immunization schedule (0, 6 months) of recombinant human papillomavirus virus-like particle vaccine (type 16 and 18 L1 proteins, yeast) (hereinafter referred as HPV-2 vaccine) in adolescent females aged 9 to 14 years in comparison to 3-dose immunization schedule (0, 2, 6 months) in young females aged 18 to 26 years.

Clinical Trial Description

The study plans to enroll 600 adolescent females aged 9 to 14 years and 300 adult females aged 18 to 26 years. The adolescents will be divided into two cohorts, 300 each, receiving either a 2-dose (0, 6 months) immunization schedule or a 3-dose (0, 2, 6 months) immunization schedule. The adult female group will receive a 3-dose (0, 2, 6 months) immunization schedule. Each subject shall be administrated with the studied vaccine according to either 2-dose or 3-dose schedule as above. Immediate reactions occurred during 30 minutes after each inoculation, all the local and systematic reactions occurred from 0 to 7 days after each inoculation will be recorded. All the adverse events (AEs) occurred from the first dose of administration to 1 month after the final dose of administration, as well as all the serious adverse events (SAEs) occurred from the first dose of administration to 6 months after the final dose of administration will be collected. Blood samples will be collected at day 0 (prior to immunization) , month 6 (prior to the last injection) , month 7, month 12, month 24, and month 36. All the blood samples will be tested HPV 16- and HPV 18-specific antibody titers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02740777
Study type Interventional
Source Shanghai Zerun Biotechnology Co.,Ltd
Contact
Status Completed
Phase Phase 2
Start date February 2016
Completion date July 2019
View Details
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