Evaluating Safety and Immune Response Consistency of 9-Valent HPV Vaccine in Chinese Women Ages 18 to 30

What this Trial Is About

Researchers are studying the lot-to-lot consistency of immunogenicity and safety for a recombinant 9-valent human papillomavirus HPV vaccine made using Escherichia coli. This clinical trial focuses on females aged 18 to 30 years in China and aims to determine if immune responses are consistent across three commercial vaccine batches. The study supports international market access and meets World Health Organization Prequalification requirements. Participants receive three doses of the investigational 9-valent HPV vaccine at months 0, 1, and 6. The study includes visits at months 0, 1, 2, 6, and 7, with blood samples collected at months 0 and 7 to measure antibody levels. Participants keep diaries of adverse events for 30 days after each vaccination and report serious or special interest adverse events and pregnancies during the trial. During the study, participants undergo assessments of immune responses by measuring antibody concentrations one month after completing vaccination. Safety is monitored by documenting adverse events throughout the seven-month period. The trial evaluates geometric mean concentrations, seroconversion, and seropositivity rates of antibodies to HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. Overall participant involvement lasts about seven months, including vaccination and follow-up visits.

Lot-to-Lot Consistency Clinical Trial of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli)