A Phase 4 interventional study of 9-valent HPV vaccine (Cecolin 9) in Infection by Human Papilloma Virus, sponsored by Xiamen Innovax Biotech Co., Ltd. Recruiting at 1 site in China. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Xiamen Innovax Biotech Co., Ltd · Phase 4, Interventional, and Prevention
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:
Participants will:
Exclusion Criteria:
Biological: 9-valent HPV vaccine (Cecolin 9)
Biological: 9-valent HPV vaccine (Cecolin 9)
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)
Geometric mean concentrations (GMCs) of naturalizing antibody to HPV6/11/16/18/31/33/45/52/58
Type-specific (HPV6/11/16/18/31/33/45/52/58) naturalizing antibody GMCs. Neutralizing antibody testing will adopt the pseudovirus-based neutralization assay (PBNA).
Time frame: One month after full vaccination (Month 7)
Seroconversion rates of naturalizing antibody to HPV6/11/16/18/31/33/45/52/58
Type-specific (HPV6/11/16/18/31/33/45/52/58) naturalizing antibody seroconversion rates. Neutralizing antibody testing will adopt the PBNA. The percentage of participants with a ≥4-fold increase in antibody level relative to baseline for each HPV type.
Time frame: One month after full vaccination (Month 7)
Seropositivity rates of naturalizing antibody to HPV6/11/16/18/31/33/45/52/58
Type-specific (HPV6/11/16/18/31/33/45/52/58) naturalizing antibody seropositivity rates. Neutralizing antibody testing will adopt the PBNA. The percentage of participants who are seropositive for each HPV type.
Time frame: One month after full vaccination (Month 7)
Percentage of participants experiencing solicited adverse events (AEs)
Solicited AEs include (1) solicited local AEs: injection-site pain, induration, erythema, swelling, pruritus; (2) solicited systemic AEs: fever, hypersensitivity reactions, headache, dizziness, fatigue, asthenia, nausea, vomiting, diarrhoea, myalgia and cough.
Time frame: Within 7 days after each vaccination
Percentage of participants experiencing unsolicited AEs
Unsolicited AEs include all AEs other than solicited AEs that occur within 7 days after vaccination, as well as all AEs occur between Day 8 and Day 30.
Time frame: Within 30 days after each vaccination
Percentage of participants experiencing all AEs
Include both solicited and unsolicited AEs.
Time frame: Within 30 days after each vaccination
Percentage of participants experiencing SAEs
A SAE is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event.
Time frame: Through study completion, an average of 7 months.
Percentage of participants experiencing AESIs
The AESIs include predominantly new-onset autoimmune diseases.
Time frame: Through study completion, an average of 7 months.
Percentage of participants experiencing pregnancy events.
Pregnancy events include any pregnancy and its outcomes (e.g., maternal, fetal and neonatal outcomes).
Time frame: Through study completion, an average of 7 months.
Plan to share: No
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Xiamen Innovax Biotech Co., Ltd