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Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)

Primary Purpose

Hepatitis A, Measles, Mumps

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
VAQTA®
ProQuad
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis A

Eligibility Criteria

12 Months - 17 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Negative clinical history of hepatitis A, measles, mumps, rubella, varicella (chickenpox), and/or zoster No other vaccinations scheduled to be administered at the time of the first or second doses of VAQTA(TM) and ProQuad(TM) Exclusion Criteria: Previously vaccinated with any hepatitis A vaccine, measles, mumps, rubella, and/or varicella vaccine either alone or in any combination History of allergy to any vaccine component History of seizure disorder Immunosuppressed including congenial and acquired conditions and immunosuppressive therapy Known severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injections Recent (<72 hours) febrile illness (>100.3 degrees F [>37.9 degrees C] oral equivalent) prior to study vaccination.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Arm 1: vaccine

    Arm 2: Active comparator

    Outcomes

    Primary Outcome Measures

    Participants With 1 or More Serious Vaccine-Related Adverse Experiences
    Participants With 1 or More Injection-Site Adverse Experiences
    Participants With Measles-Like Rash After First Vaccination
    Participants With Measles-Like Rash After Second Vaccination
    Participants With Mumps-Like Symptoms After First Vaccination
    Participants With Mumps-Like Symptoms After Second Vaccination
    Participants With Rubella-Like Rash After First Vaccination
    Participants With Rubella-Like Rash After Second Vaccination
    Participants With Varicella/Zoster-Like Rash After First Vaccination
    Participants With Varicella/Zoster-Like Rash After Second Vaccination
    Participants With Elevated Temperature (>=102.2F/39.0C)

    Secondary Outcome Measures

    Participants With 1 or More Systemic Adverse Experiences

    Full Information

    First Posted
    May 12, 2006
    Last Updated
    January 16, 2019
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00326183
    Brief Title
    Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)
    Official Title
    An Open, Multicenter Study of the Safety and Tolerability of VAQTA(TM) and ProQuad(TM) in Healthy Children 12 to 23 Months of Age
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 26, 2007 (Actual)
    Primary Completion Date
    January 15, 2008 (Actual)
    Study Completion Date
    January 15, 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
    Two doses each of Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella [Oka/Merck] Virus Vaccine Live will be given concomitantly or non-concomitantly. Safety data will be collected following each vaccination.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis A, Measles, Mumps, Rubella, Chickenpox

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1800 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Arm 1: vaccine
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Arm 2: Active comparator
    Intervention Type
    Biological
    Intervention Name(s)
    VAQTA®
    Other Intervention Name(s)
    V251
    Intervention Description
    0.5 ml injection VAQTA®; 2nd 0.5 ml injection VAQTA® 24 week period of treatment.
    Intervention Type
    Biological
    Intervention Name(s)
    ProQuad
    Intervention Description
    0.5 ml injection ProQuad; 2nd 0.5 ml injection ProQuad®. 24 week period of treatment.
    Primary Outcome Measure Information:
    Title
    Participants With 1 or More Serious Vaccine-Related Adverse Experiences
    Time Frame
    Days 1 to 14 after any vaccination
    Title
    Participants With 1 or More Injection-Site Adverse Experiences
    Time Frame
    Days 1 to 14 after any vaccination
    Title
    Participants With Measles-Like Rash After First Vaccination
    Time Frame
    Days 1 to 28 After First Vaccination
    Title
    Participants With Measles-Like Rash After Second Vaccination
    Time Frame
    Days 1 to 28 After Second Vaccination
    Title
    Participants With Mumps-Like Symptoms After First Vaccination
    Time Frame
    Days 1 to 28 After First Vaccination
    Title
    Participants With Mumps-Like Symptoms After Second Vaccination
    Time Frame
    Days 1 to 28 After Second Vaccination
    Title
    Participants With Rubella-Like Rash After First Vaccination
    Time Frame
    Days 1 to 28 After First Vaccination
    Title
    Participants With Rubella-Like Rash After Second Vaccination
    Time Frame
    Days 1 to 28 After Second Vaccination
    Title
    Participants With Varicella/Zoster-Like Rash After First Vaccination
    Time Frame
    Days 1 to 28 After First Vaccination
    Title
    Participants With Varicella/Zoster-Like Rash After Second Vaccination
    Time Frame
    Days 1 to 28 After Second Vaccination
    Title
    Participants With Elevated Temperature (>=102.2F/39.0C)
    Time Frame
    Days 1 to 5 After Any Vaccination
    Secondary Outcome Measure Information:
    Title
    Participants With 1 or More Systemic Adverse Experiences
    Time Frame
    Days 1 to 14 After Any Vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    17 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Negative clinical history of hepatitis A, measles, mumps, rubella, varicella (chickenpox), and/or zoster No other vaccinations scheduled to be administered at the time of the first or second doses of VAQTA(TM) and ProQuad(TM) Exclusion Criteria: Previously vaccinated with any hepatitis A vaccine, measles, mumps, rubella, and/or varicella vaccine either alone or in any combination History of allergy to any vaccine component History of seizure disorder Immunosuppressed including congenial and acquired conditions and immunosuppressive therapy Known severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injections Recent (<72 hours) febrile illness (>100.3 degrees F [>37.9 degrees C] oral equivalent) prior to study vaccination.
    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

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    30431383
    Citation
    Petrecz M, Acosta CJ, Klopfer SO, Kuter BJ, Goveia MG, Stek JE, Schodel FP, Lee AW. Safety and immunogenicity of VAQTA(R) in children 12-to-23 months of age with and without administration of other US pediatric vaccines. Hum Vaccin Immunother. 2019;15(2):426-432. doi: 10.1080/21645515.2018.1530934. Epub 2018 Nov 15.
    Results Reference
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    Hepatitis A Vaccine, Inactivated and Measles, Mumps, Rubella and Varicella Virus Vaccine Live Safety Study (V251-066)(COMPLETED)

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