- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03085381
A Phase I Study of Quadrivalent HPV Recombinant Vaccine
September 12, 2018 updated by: Shanghai Bovax Biotechnology Co., Ltd.
A Randomized, Double-Blind and Placebo-Controlled Phase I Study to Evaluate the Safety and Primary Immunogenicity of the Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years
To evaluate the safety and primary immunogenicity of the quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine (hansenula polymorpha) in Chinese female subjects aged 9-45 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Guangxi
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Liuzhou, Guangxi, China
- Liu Zhou Centre for Disease Control and Prevention
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 45 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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, or planned administration/administration of a vaccine not foreseen by the study protocol within 30 days preceding first dose of vaccine; Planned to take part in other clinical research within 7 months after participating this study
- Abnormal laboratory tests parameters
- 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
- History of serious allergic disease requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
- History of to adverse event to vaccine, or allergic to some food or drug
- History of epilepsy, seizures or convulsions, or family history of mental illness
- Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose.
- Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
- Subject to severe hepatorenal disease, cardiovascular disease, hypertension, diabetes, malignant tumor, all kinds of infectious diseases and acute illness, or during chronic disease acute attack period
- Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
- During menstrual period or acute disease period of onset
- Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months
- Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years
- Planned to moveout of local before the end of the study or leave the local for a long time during the study period
- Other unsuitable factors for the study judged by investigators
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: HPV vaccine
Subjects received 3 doses of HPV vaccine according to a 0, 2, 6-month schedule.
|
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PLACEBO_COMPARATOR: Placebo
Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Systemic and local adverse events during the period of first dose vaccination to 30 days after last dose of vaccination
Time Frame: 30 days after last dose of vaccination
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30 days after last dose of vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zhaojun Mo, Master, Guangxi Centers for Disease Control and Prevention
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 1, 2016
Primary Completion (ACTUAL)
October 1, 2017
Study Completion (ACTUAL)
August 1, 2018
Study Registration Dates
First Submitted
March 19, 2017
First Submitted That Met QC Criteria
March 19, 2017
First Posted (ACTUAL)
March 21, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 14, 2018
Last Update Submitted That Met QC Criteria
September 12, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-HPV-1001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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