An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00635830

Purpose

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.

Condition	Intervention	Phase
HPV Infections	Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine	Phase I

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Open-Label, Single-Dose, Safety and Tolerability Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Chinese Female Subjects Aged 9 to 26 Years

Further study details as provided by Merck:

Primary Outcome Measures:

Measure Serious Adverse Experiences, Systemic Adverse Experiences Occurring Within 14 Days After Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Vaccination [ Time Frame: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after one dose of vaccination; For injection-site adverse experiences: 5 days follow-up after one dose of vaccination ] [ Designated as safety issue: Yes ]

Enrollment:	40
Study Start Date:	March 2008
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Open Label	Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.

Eligibility

Ages Eligible for Study:	9 Years to 26 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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])

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635830

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2008_003, V501-035
Study First Received:	March 3, 2008
Results First Received:	March 17, 2009
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00635830 History of Changes
Health Authority:	China: Ministry of Health

Study placed in the following topic categories:

Virus Diseases

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on September 10, 2009