An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
Primary Purpose
HPV Infections
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for HPV Infections
Eligibility 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])
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Open Label
Outcomes
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
All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00635830
Brief Title
An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HPV Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Open Label
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine
Other Intervention Name(s)
V501
Intervention Description
HPV 6,11,16,18 VLP, 0.5 mL 1 dose injection.
Primary Outcome Measure Information:
Title
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
Description
All adverse experiences were collected from the time the consent form was signed through 14 days following the vaccination. All subjects were requested to record injection-site adverse experiences and monitor temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after injection
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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])
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
An Open-Label, Single Dose Safety Study of Quadrivalent HPV Vaccine in Chinese Female Subjects (V501-035)
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