Evaluate the Safety and Primary Immunogenicity of 9-valent HPV Recombinant Vaccine in Chinese Healthy Females

Shanghai Bovax Biotechnology

Status and phase

Completed

Phase 1

Conditions

CIN2

Vin III

Vaginal Cancer

VaIN3

VaIN2

Invasive Carcinoma

Genital Wart

Mild Dysplasia of Vulva

Moderate Dysplasia of Vulva

CIN1

Vulvar Cancer

CIN 3

Cervical Cancers

VaIN1

AIS

Treatments

Biological: Placebo

Biological: 9-valent HPV Recombinant Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT03676101

9-HPV-1001

Details and patient eligibility

About

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.

Enrollment

90 patients

Sex

Female

Ages

9 to 45 years old

Volunteers

Accepts Healthy Volunteers

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
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
Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months
During acute disease (including infectious and non-infectious disease) and chronic diease period of onset
Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years
Planned to move out 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