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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cecolin 9 - Lot 1 group | Experimental |
| |
| Cecolin 9 - Lot 2 group | Experimental |
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| Cecolin 9 - Lot 3 group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9-valent HPV vaccine (Cecolin 9) | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | One month after full vaccination (Month 7) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month after full vaccination (Month 7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiufen Zhang | Contact | +865926536555 | qiufen_zhang@innovax.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhangping Center for Disease Control and Prevention | Recruiting | Zhangping | Fujian | 364400 | China |
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| 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. | 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. | 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. | Within 30 days after each vaccination |
| Percentage of participants experiencing all AEs | Include both solicited and unsolicited AEs. | 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. | Through study completion, an average of 7 months. |
| Percentage of participants experiencing AESIs | The AESIs include predominantly new-onset autoimmune diseases. | 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). | Through study completion, an average of 7 months. |