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)

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
To support international market access and comply with World Health OrganizationPrequalification requirements, this lot‐to‐lot consistency trial is planned forinitiation. The goal of this clinical trial is to evaluate lot‐to‐lot immunogenicity andsafety 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 aimsto answer is:· Is immunogenicity consistent across three commercially produced batches of RecombinantHuman Papillomavirus 9‐valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichiacoli)? Researchers will compare the immune responses at 1 month post full vaccination tosee 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.
Epistemonikos ID: 7ec618f602e5bc64bfd87f726b7f3ca370fea0f5
First added on: Jun 26, 2026