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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
720
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)
Zhangping Center for Disease Control and Prevention
Zhangping, Fujian, China
RECRUITINGGeometric 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.
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