Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Hea… (NCT03676101) | Clinical Trial Compass
CompletedPhase 1
Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females
China90 participantsStarted 2018-10-10
Plain-language summary
To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.
Who can participate
Age range
9 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:
* Healthy females between, and including, 9 and 45 years of age at the time of enrolment
* Be able to provide legal identification for the sake of recruitment
* Be able to understand and sign informed consent form prior to enrollment and for subjects aged 9-17 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together
* Subjects who the investigator believes that they can and will comply with the protocol requirements
* Subject must be not pregnant at the enrollment and agree to use adequate contraceptive precautions within 7 months or don't have pregnancy plan
Exclusion Criteria:
* Fever or axillary temperature\> 37.0℃ before vaccination
* Previous vaccination against HPV
* Planned administration/administration of investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding first dose of vaccine
* Planned to take part in other clinical research within 7 months after participating this study or have taken part in other clinical research within 3 months before participating this study
* Abnormal laboratory tests parameters(except the part the clinician diagnosed as non clinical significance)
* Administration of any whole blood, plasma or immunoglobulins products within 3 months preceding first vaccination
* Interval between administration of the study vaccination and any attenuated live vaccine less than 14 days, and other vaccines less than 10 days
* His…
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
Number of Subjects Reporting Solicited Adverse Events
Timeframe: 7 days after each vaccination
2
Number of Subjects Reporting Unsolicited Adverse Events
Timeframe: 30 days after each vaccination
3
Number of Subjects Reporting Serious Adverse Events
Timeframe: 30 days after third dose of vaccination