search
Back to results

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
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HPV Infections

Eligibility Criteria

9 Years - 26 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    March 3, 2008
    Last Updated
    October 8, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    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)

    We'll reach out to this number within 24 hrs