drugset / Trial / NCT02740790

Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females

NCT02740790

Phase 2 Completed 1200 enrolled Shanghai Zerun Biotechnology Co.,Ltd
RandomizedParallel-groupDouble-blindPrevention

Summary

Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16 and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26 years age group and 27-45 years age group in terms of immunogenicity.

Timeline

Start
2013-09
Primary completion
2015-09
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gardasil Vaccine 0.5 ml Intramuscular