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 range9 Years – 45 Years
SexFEMALE
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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…
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