Clinical Research Directory

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)

To support international market access and comply with World Health Organization Prequalification requirements, this lot-to-lot consistency trial is planned for initiation. The goal of this clinical trial is to evaluate lot-to-lot immunogenicity and safety of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli) in 18-30 years-old females in China. The main question it aims to answer is: · Is immunogenicity consistent across three commercially produced batches of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia coli)? Researchers will compare the immune responses at 1 month post full vaccination to see if the lot-to-lot consistency of immunogenicity can be achieved. Participants will: * Visit the clinic site on Month 0, 1, 2, 6 and 7. * Take 3 doses of investigational vaccine on Month 0, 1 and 6. * Provide approximately 5.0 mL venous blood samples on Month 0 and Month 7. * Keep a diary of their adverse events (AEs) within 30 days after each vaccination. * Report serious adverse events (SAEs), adverse events of special interest (AESIs), and pregnancies occurring during the trial.