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

NCT01263327 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-07-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

HPV 16/18

Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.

Sponsors & Collaborators

  • Xiamen Innovax Biotech Co., Ltd

    collaborator INDUSTRY

  • Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

    collaborator INDUSTRY

  • Xiamen University

    lead OTHER

Principal Investigators

  • Yue-mei Hu, Bachelor · Jiangsu Provincial Centre for Disease Control and Prevention

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01263327 on ClinicalTrials.gov