Clinical Trial of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

Xiamen University

Status and phase

Completed

Phase 1

Conditions

Cervical Cancer

Treatments

Biological: HPV 16/18

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01263327

HPV-PRO-001

Details and patient eligibility

About

This phase I clinical study was designed to evaluate the safety of novel recombinant HPV 16/18 bivalent vaccine, manufactured by Xiamen Innovax Biotech CO., LTD., in healthy women 18-55 years of age at enrolment. Approximately 30 study subjects will receive the novel HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.

Enrollment

38 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Written informed consent from the subject prior to enrolment;
Female between, and including, 18 and 55 years of age at the time of enrolment;
Subjects must be free of obvious health problems;
Not pregnant and having no plan for pregnancy;

Exclusion criteria

Pregnant or breastfeeding or having plan for pregnancy during the whole study (Month 0-7);
Previous vaccination against HPV;
Having severe allergic history or other immunodeficiency;
Chemotherapy and other immunosuppressive agents using;