A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine (NCT05694728) | Clinical Trial Compass
CompletedPhase 2
A Phase II Trial Evaluate the Immunogenicity and Safety Profile of HPV Vaccine
China780 participantsStarted 2020-05-23
Plain-language summary
This trail is to evaluate the safety profile of Recombinant Nonavalent (Types 6/11/16/18/31/33/45/52/58) Human Papillomavirus (HPV) Vaccine (Escherichia Coli) in healthy Chinese women ages 20-45 and determine the optimal ratio of the antigens included in the investigational vaccine. Besides, the trail is also to demonstrate that the levels of neutralizing antibodies to vaccine HPV types 31, 33, 45, 52 and 58 elicited by the investigational vaccine with the chosen optimal antigen ratio are superior to those induced by Gardasil.
Who can participate
Age range
20 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female subjects ages 20-45 (inclusive of 20 years of age and 45 years of age);
. Subjects decided to be healthy by the principal investigator in accordance with such trial subjects' medical history and physical examination results;
. Subjects who agree to participate in the trial after being fully informed of the study, and provide a written informed consent;
. Trial subjects who are able to comply with protocol-specified requirements;
. Trial subjects with negative urine pregnancy test at screening;
. Trial subjects with no childbearing potential (e.g. females who have undergone bilateral tubal ligation, hysterectomy, bilateral oophorectomy, etc), or female subjects with childbearing potential who have agreed to abstain from any sexual activity that could result in pregnancy or practice adequate contraception for at least 28 days prior to the first dose of the interventions and throughout the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of adverse reactions up to Day 7 after each dose of the interventions
Timeframe: 0-7 days after each immunization
2
To determine the optimal ratio of antigens included in the investigational vaccine
. Women who are pregnant or breastfeeding, or planning for pregnancy in the following 7 months;
. Women who have received other HPV vaccine(s) prior to dose 1 of the interventions;
. Women who have received an investigational or unregistered drug or vaccine within 28 days prior to the first dose of the interventions, or plan to receive an investigational or unregistered drug or vaccine during the study;
. Women who have known anaphylaxis history or are allergic to any component of the interventions, such as penicillin and amikacin;
. Women with a history of severe adverse reactions to previous vaccinations, such as allergies, urticaria, dyspnea, angioneurotic edema, or abdominal pain;
. Women who have an autoimmune disease or immunodeficiency, are HIV positive, or have primary diseases in vital organs;
. Women who have asthma that is unstable and requires urgent care, hospitalization and the use of oral or intravenous corticosteroids during the past 2 years;
. Women who have diabetes mellitus (type I or II), with the exception of gestational diabetes;