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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)

NCT07668271 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2026-06-25

No results posted yet for this study

Summary

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.

Conditions

  • Infection by Human Papilloma Virus

Interventions

BIOLOGICAL

9-valent HPV vaccine (Cecolin 9)

Recombinant human papillomavirus 9-valent (types 6/11/16/18/31/33/45/52/58) vaccine (Escherichia Coli) (Xiamen Innovax Biotech Co., Ltd., Xiamen, China)

Sponsors & Collaborators

  • Xiamen Innovax Biotech Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-26
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668271 on ClinicalTrials.gov