drugset / Trial / NCT02740777

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

NCT02740777

RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2016-02
Primary completion
2016-11
Completion
2019-07

Drugs

EvaluationDrugModalityDoseRoute
Subject HPV 16/18 VLP AS04 Vaccine 20 ug
Subject HPV 16/18 VLP AS04 Vaccine 40 ug
Subject HPV 16/18 VLP AS04 Vaccine 225 ug