Dose-Ranging Study 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 April 2011 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:

NCT01356823

First received: May 13, 2011

Last updated: May 17, 2011

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 13, 2011

Last Updated Date

May 17, 2011

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

Seroconversion of anti-HPV 16 and anti-HPV 18 neutralizing antibody [ Time Frame: 7 months ] [ Designated as safety issue: No ]

To detect the anti-HPV 16 and anti-HPV 18 neutralizing antibody level on day 1 and one month after dose 3.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01356823 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of Participants with Adverse Events [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

All the adverse events in one month after each dose would be recorded in the diary card. All the Serious Adverse Events(SAE) occurred during clinical trial time frame would be recorded.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine

Official Title ^ICMJE

A Randomized, Double-Blinded, Placebo-Controlled, Dose-Ranging Study of Recombinant Human Papillomavirus Virus 16/18 Bivalent Vaccine (E.Coli)in Healthy Female Subjects Aged 18 to 25 Years

Brief Summary

This is a phase II clinical study of the novel recombinant HPV 16/18 bivalent vaccine manufactured by Xiamen Innovax Biotech CO., LTD. The aim of this study is to evaluate the immunogenicity and safety of different vaccine dosage in healthy women 18-25 years of age at enrolment. Approximately 1600 study subjects will be enrolled and randomly stratified into 4 groups and receive different dosage of human papillomavirus (HPV) vaccine or placebo administered intramuscularly according to a 0-1-6 month schedule.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Cervical Intraepithelial Neoplasia
Cervical Cancer

Intervention ^ICMJE

Biological: Human papillomavirus type 16/18 Bivalent Vaccine
3 doses at day 1, month 1 and month 6
Biological: HBV vaccine
3 doses at day 1, month 1 and month 6

Study Arm (s)

Experimental: 30μg dosage
This dosage contains 20μg HPV 16 antigen and 10μg HPV 18 antigen

Intervention: Biological: Human papillomavirus type 16/18 Bivalent Vaccine
Experimental: 60μg dosage
This dosage contains 40μg HPV 16 antigen and 20μg HPV 18 antigen

Intervention: Biological: Human papillomavirus type 16/18 Bivalent Vaccine
Experimental: 90μg dosage
This dosage contains 60μg HPV 16 antigen and 30μg HPV 18 antigen

Intervention: Biological: Human papillomavirus type 16/18 Bivalent Vaccine
Placebo Comparator: HBV vaccine
This arm is HBV vaccine which contains 10μg HBV antigen.

Intervention: Biological: HBV 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

1600

Estimated Completion Date

December 2011

Estimated Primary Completion Date

December 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 25 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 25 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Yuemei Hu, Bachelor

86-25-83759399

huyuemei@hotmail.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01356823

Other Study ID Numbers ^ICMJE

HPV-PRO-002

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

Study Chair:	Jun Zhang, Master	Xiamen University
Principal Investigator:	Yuemei Hu, Bachelor	Jiangsu Provincial Centre for Disease Control and Prevention
Study Director:	Ting Wu, Ph. D	Xiamen University

Information Provided By

Xiamen University

Verification Date

April 2011

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

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