An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-04-30

Brief Summary

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To prove that quadrivalent HPV (types 6, 11, 16, 18) L1 virus-like particle (VLP) vaccine is generally safe and well tolerated in the Chinese population.

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Detailed Description

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Conditions

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HPV Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Open Label

Group Type EXPERIMENTAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Intervention Type BIOLOGICAL

HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.

Interventions

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Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.

Intervention Type BIOLOGICAL

Other Intervention Names

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V501

Eligibility Criteria

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Inclusion Criteria

* Subject Is Female, Between The Ages Of 9 Years And 0 Days And 26 Years And 364 Days On The Day Of Enrollment
* Subject (Or, For Minor Subjects, Parent/Legal Guardian And Subject) Fully Understands Study Procedures, Alternative Treatments Available, The Risks Involved With The Study, And Voluntarily Agrees To Participate By Giving Written Informed Consent
* Subject Is Able To Read, Understand, And Complete The Vaccination Report Card

Exclusion Criteria

* Subject Is, At The Time Of Signing Informed Consent, A User Of Recreational Or Illicit Drugs Or Has Had A Recent History (Within The Last Year) Of Drug Or Alcohol Abuse Or Dependence. Alcohol Abusers Are Defined As Those Who Drink Despite Recurrent Social, Interpersonal, And/Or Legal Problems As A Result Of Alcohol Use
* Subject Has A History Of Severe Allergic Reaction (E.G., Swelling Of The Mouth And Throat, Difficulty Breathing, Hypotension Or Shock) That Required Medical Intervention
* Subject Has Known Allergy To Any Vaccine Component, Including Aluminum, Yeast, Or Benzonase (Nuclease, Nycomed \[Used To Remove Residual Nucleic Acids From This And Other Vaccines\])

Minimum Eligible Age

9 Years

Maximum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes