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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HPV 16/18

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

Group Type EXPERIMENTAL

HPV 16/18

Intervention Type BIOLOGICAL

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

Interventions

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HPV 16/18

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes