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Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MMRV (AMP)
MMRV (2006 process)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Measles

Eligibility Criteria

12 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Negative clinical history for measles, mumps, rubella, varicella, and zoster

Exclusion Criteria:

  • Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study
  • Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study
  • Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
  • Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy
  • Received 1) systemic immunomodulatory steroids [greater than the

equivalent of 2 mg/kg total daily dose of prednisone] within 3 months prior to

entering the study, or 2) any dose of systemic immunomodulatory steroids within

7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study

  • History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines
  • Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination
  • Diagnosis of an active neurological disorder. Enrollment may be considered

when the disease process has been stabilized

  • History of seizure disorder, including single febrile seizure
  • Diagnosis of active untreated tuberculosis
  • History of thrombocytopenia
  • Born to a human immunodeficiency virus (HIV) infected mother

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MMRV (AMP)

    MMRV (2006 process)

    Arm Description

    Participants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)

    Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL
    Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
    Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL
    Sera were tested for measles virus IgG antibody levels by an ELISA
    Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL
    Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
    Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)
    Sera were tested for rubella virus IgG antibody levels by an ELISA
    Geometric Mean Titer (GMT) of VZV Antibodies
    Sera were tested for VZV IgG antibody levels by gpELISA
    Geometric Mean Titer (GMT) of Measles Virus Antibodies
    Sera were tested for measles virus IgG antibody levels by ELISA
    Geometric Mean Titer (GMT) of Mumps Virus Antibodies
    Sera were tested for mumps virus IgG antibody levels by ELISA
    Geometric Mean Titer (GMT) of Rubella Virus Antibodies
    Sera were tested for rubella virus IgG antibody levels by ELISA
    Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

    Secondary Outcome Measures

    Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
    Percentage of Participants With Zoster-like Rash
    Percentage of Participants With Mumps-like Symptoms
    Percentage of Participants With Measles-like Rash
    Percentage of Participants With Rubella-like Rash
    Percentage of Participants With Varicella-like Rash
    Percentage of Participants With an Injection-site Adverse Event
    An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.

    Full Information

    First Posted
    February 16, 2012
    Last Updated
    October 1, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01536405
    Brief Title
    Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
    Official Title
    A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    June 5, 2012 (Actual)
    Primary Completion Date
    July 2, 2013 (Actual)
    Study Completion Date
    January 27, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1412 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MMRV (AMP)
    Arm Type
    Experimental
    Arm Description
    Participants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
    Arm Title
    MMRV (2006 process)
    Arm Type
    Active Comparator
    Arm Description
    Participants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process
    Intervention Type
    Biological
    Intervention Name(s)
    MMRV (AMP)
    Intervention Description
    Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
    Intervention Type
    Biological
    Intervention Name(s)
    MMRV (2006 process)
    Other Intervention Name(s)
    ProQuad™
    Intervention Description
    Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL
    Description
    Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)
    Time Frame
    Six weeks after vaccination 1
    Title
    Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL
    Description
    Sera were tested for measles virus IgG antibody levels by an ELISA
    Time Frame
    Six weeks after vaccination 1
    Title
    Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL
    Description
    Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)
    Time Frame
    Six weeks after vaccination 1
    Title
    Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)
    Description
    Sera were tested for rubella virus IgG antibody levels by an ELISA
    Time Frame
    Six weeks after vaccination 1
    Title
    Geometric Mean Titer (GMT) of VZV Antibodies
    Description
    Sera were tested for VZV IgG antibody levels by gpELISA
    Time Frame
    Six weeks after vaccination 1
    Title
    Geometric Mean Titer (GMT) of Measles Virus Antibodies
    Description
    Sera were tested for measles virus IgG antibody levels by ELISA
    Time Frame
    Six weeks after vaccination 1
    Title
    Geometric Mean Titer (GMT) of Mumps Virus Antibodies
    Description
    Sera were tested for mumps virus IgG antibody levels by ELISA
    Time Frame
    Six weeks after vaccination 1
    Title
    Geometric Mean Titer (GMT) of Rubella Virus Antibodies
    Description
    Sera were tested for rubella virus IgG antibody levels by ELISA
    Time Frame
    Six weeks after vaccination 1
    Title
    Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
    Time Frame
    Up to 5 days after vaccination 1
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)
    Time Frame
    Up to 42 days after each vaccination
    Title
    Percentage of Participants With Zoster-like Rash
    Time Frame
    Up to 42 days after each vaccination
    Title
    Percentage of Participants With Mumps-like Symptoms
    Time Frame
    Up to 42 days after each vaccination
    Title
    Percentage of Participants With Measles-like Rash
    Time Frame
    Up to 42 days after each vaccination
    Title
    Percentage of Participants With Rubella-like Rash
    Time Frame
    Up to 42 days after each vaccination
    Title
    Percentage of Participants With Varicella-like Rash
    Time Frame
    Up to 42 days after each vaccination
    Title
    Percentage of Participants With an Injection-site Adverse Event
    Description
    An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.
    Time Frame
    Up to 5 days after each vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    23 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Negative clinical history for measles, mumps, rubella, varicella, and zoster Exclusion Criteria: Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy Received 1) systemic immunomodulatory steroids [greater than the equivalent of 2 mg/kg total daily dose of prednisone] within 3 months prior to entering the study, or 2) any dose of systemic immunomodulatory steroids within 7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination Diagnosis of an active neurological disorder. Enrollment may be considered when the disease process has been stabilized History of seizure disorder, including single febrile seizure Diagnosis of active untreated tuberculosis History of thrombocytopenia Born to a human immunodeficiency virus (HIV) infected mother
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php
    Citations:
    PubMed Identifier
    27149048
    Citation
    Marshall GS, Senders SD, Shepard J, Twiggs JD, Gardner J, Hille D, Hartzel J, Valenzuela R, Stek JE, Helmond FA. A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process. Hum Vaccin Immunother. 2016 Aug 2;12(8):2188-2196. doi: 10.1080/21645515.2016.1165374. Epub 2016 May 5.
    Results Reference
    result
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=V221-027&kw=V221-027&tab=access

    Learn more about this trial

    Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

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