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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2010 by Xiamen University.
Recruitment status was Recruiting

Sponsor:

Collaborators:

Xiamen Innovax Biotech Co., Ltd

Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd

Information provided by:

Xiamen University

ClinicalTrials.gov Identifier:

NCT01263327

First received: December 17, 2010

Last updated: NA

Last verified: December 2010

History: No changes posted

Tracking Information

First Received Date ^ICMJE

December 17, 2010

Last Updated Date

December 17, 2010

Start Date ^ICMJE

December 2010

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Measure injection-site complaints within 7 days after each vaccination; Measure systematic adverse reactions within 1 month after vaccination; Measure serious adverse experience; Measure blood, liver and kidney functions pre- and 3 days post vaccination. [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

An Open-Label, Single-dose, Non-Randomized, Safety and Tolerability Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 55 Years

Brief Summary

This phase I clinical study will 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Human Papillomavirus 16
Human Papillomavirus 18

Intervention ^ICMJE

Biological: Human Papillomavirus Virus 16/18 Bivalent Vaccine

administered intramuscularly according to a 0-1-6 month schedule

Study Arm (s)

Experimental: Human Papillomavirus Virus 16/18 Bivalent Vaccine

Intervention: Biological: Human Papillomavirus Virus 16/18 Bivalent Vaccine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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;

Gender

Female

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Yue-mei Hu, Bachelor

86-25-83759399

huyuemei@hotmail.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01263327

Other Study ID Numbers ^ICMJE

HPV-PRO-001

Has Data Monitoring Committee

Responsible Party

Ting Wu/Dr, Xiamen University

Study Sponsor ^ICMJE

Xiamen University

Collaborators ^ICMJE

Xiamen Innovax Biotech Co., Ltd
Beijing Wantai Biological Pharmacy Enterprise Co.,Ltd

Investigators ^ICMJE

Principal Investigator:

Yue-mei Hu, Bachelor

Jiangsu Provincial Centre for Disease Control and Prevention

Information Provided By

Xiamen University

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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