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

Shanghai Bovax Biotechnology Co., Ltd.1 site in 1 country90 target enrollmentDecember 2016

ConditionsHPV Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HPV Infections
Sponsor: Shanghai Bovax Biotechnology Co., Ltd.
Enrollment: 90
Locations: 1
Primary Endpoint: Systemic and local adverse events during the period of first dose vaccination to 30 days after last dose of vaccination
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

August 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Shanghai Bovax Biotechnology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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