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New treatment option for Infection by Human Papilloma Virus
Official title 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)
ClinicalTrials.gov ID: NCT07668271
What this study is testing
What is 9-valent HPV vaccine (Cecolin 9)?
9-valent HPV vaccine (Cecolin 9) is an investigational medicine, being studied as a potential treatment for infection by human papilloma virus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 30, women only. Healthy volunteers may be eligible.
You may be able to join if
- Chinese female participants aged 18 to 30 years old who can provide legal identity documentation at screening, i.e., at least 18 years of age and...
- The trial participant is able to understand trial procedures and comply with protocol requirements (including biological sample collection...
- The trial participant agrees to avoid pregnancy and use effective contraceptive measures from the first vaccination through 1 month after completion...
- No prior history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, lymphogranuloma venereum, granuloma inguinale, etc.);
- No prior history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN).
You likely can't join if
- Have previously received any HPV vaccine, plan to receive any HPV vaccine not supplied in this trial during the study period, or have participated in...
- Axillary temperature \> 37.0°C;
- Positive urine pregnancy test, current pregnancy or breastfeeding status;
- Have received any other investigational or unlicensed products (medicines or vaccines) within 30 days prior to administration of the investigational...
- Have received systemic immunosuppressants, other immunomodulatory drugs or corticosteroids for a prolonged duration (≥14 consecutive days) within 6...
- Have received immunoglobulins and/or blood products within 3 months prior to vaccination, or plan to receive such products within 7 months after the...
See the full eligibility criteria
- Chinese female participants aged 18 to 30 years old who can provide legal identity documentation at screening, i.e., at least 18 years of age and less than 31 years of age;
- The trial participant is able to understand trial procedures and comply with protocol requirements (including biological sample collection, completion of diary/contact cards, and attendance of scheduled follow-up...
- The trial participant agrees to avoid pregnancy and use effective contraceptive measures from the first vaccination through 1 month after completion of full vaccination;
- No prior history of sexually transmitted diseases (including syphilis, gonorrhea, chancroid, lymphogranuloma venereum, granuloma inguinale, etc.);
- No prior history of abnormal cervical screening results or cervical intraepithelial neoplasia (CIN).
- Have previously received any HPV vaccine, plan to receive any HPV vaccine not supplied in this trial during the study period, or have participated in any clinical trial related to HPV vaccines;
- Axillary temperature \> 37.0°C;
- Positive urine pregnancy test, current pregnancy or breastfeeding status;
- Have received any other investigational or unlicensed products (medicines or vaccines) within 30 days prior to administration of the investigational vaccine, or plan to receive such products or enroll in another...
- Have received systemic immunosuppressants, other immunomodulatory drugs or corticosteroids for a prolonged duration (≥14 consecutive days) within 6 months before vaccination. Local treatments (e.g., ointments, eye...
- Have received immunoglobulins and/or blood products within 3 months prior to vaccination, or plan to receive such products within 7 months after the first vaccination;
- Have received inactivated vaccines within 14 days or live vaccines within 21 days before vaccine administration;
- Axillary temperature \> 38.0°C within 3 days prior to vaccination, or any acute disease requiring systemic antibiotic or antiviral therapy within 5 days prior to vaccination;
- Current immunocompromised status, including congenital or acquired immunodeficiency disorders, Human Immunodeficiency Virus (HIV) infection, autoimmune diseases (including asplenia or splenectomy of any cause and other...
- History of hypertension or hypotension with regular medication but unstable control; or resting brachial blood pressure readings of the trial participant showing systolic blood pressure ≥160 mmHg, diastolic blood...
- Prior or current severe illnesses with unstable conditions that may require emergency treatment or hospitalization;
- History of severe allergies, including severe adverse reactions to previous vaccinations such as dyspnea or angioedema, or known hypersensitivity to any component of the investigational vaccine (recombinant VLP protein...
- Asthma with unstable disease requiring emergency care, hospitalization, oral or intravenous corticosteroid administration in the past two years;
- Prior or current coagulation dysfunction or coagulation disorders;
- Epilepsy, excluding febrile convulsions occurring before 2 years of age, alcoholic seizures within the first 3 years of alcohol withdrawal, or simple epilepsy that has required no treatment for the past 3 years;
- Participants judged by the investigator, after medical history inquiry and relevant physical examination, to have medical, psychological, social, occupational or other conditions that may interfere with the conduct of...
The study team makes the final eligibility decision.
Where it's taking place
- Zhangping, Fujian, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 30 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhangping, Fujian, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.