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Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)

Primary Purpose

Varicella

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
VARIVAX™ New Seed Process
VARIVAX™ 2007 process
M-M-R II™
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

  • Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
  • Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
  • Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study
  • History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™
  • Received salicylates within 14 days prior to study vaccination
  • Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination
  • Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination
  • History of seizure disorder, including febrile seizure
  • Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination
  • History of thrombocytopenia
  • Born to a human immunodeficiency virus (HIV)-infected mother
  • Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    VARIVAX™ NSP + M-M-R II™

    VARIVAX™ 2007 Process + M-M-R II™

    Arm Description

    VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91

    VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91

    Outcomes

    Primary Outcome Measures

    Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
    Geometric Mean Titer of VZV Antibodies
    Antibody titers were measured with gpELISA.

    Secondary Outcome Measures

    Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)
    Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
    Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
    Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
    Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2

    Full Information

    First Posted
    February 12, 2014
    Last Updated
    October 1, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02062502
    Brief Title
    Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
    Official Title
    A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 7, 2014 (Actual)
    Primary Completion Date
    February 24, 2015 (Actual)
    Study Completion Date
    October 13, 2015 (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 evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    611 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    VARIVAX™ NSP + M-M-R II™
    Arm Type
    Experimental
    Arm Description
    VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91
    Arm Title
    VARIVAX™ 2007 Process + M-M-R II™
    Arm Type
    Active Comparator
    Arm Description
    VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91
    Intervention Type
    Biological
    Intervention Name(s)
    VARIVAX™ New Seed Process
    Intervention Description
    Varicella virus vaccine live manufactured with a new seed process
    Intervention Type
    Biological
    Intervention Name(s)
    VARIVAX™ 2007 process
    Intervention Description
    Varicella virus vaccine live manufactured with the 2007 process
    Intervention Type
    Biological
    Intervention Name(s)
    M-M-R II™
    Intervention Description
    Measles, Mumps, and Rubella virus vaccine live
    Primary Outcome Measure Information:
    Title
    Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
    Time Frame
    6 weeks (43 days) after vaccination 1
    Title
    Geometric Mean Titer of VZV Antibodies
    Description
    Antibody titers were measured with gpELISA.
    Time Frame
    6 weeks (43 days) after vaccination 1
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)
    Time Frame
    Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)
    Title
    Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
    Time Frame
    Up to 42 days after Vaccination 1
    Title
    Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
    Time Frame
    Up to 42 days after Vaccination 2
    Title
    Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
    Time Frame
    Up to 5 days after Vaccination 1
    Title
    Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
    Time Frame
    Up to 5 days after Vaccination 2

    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 varicella, herpes zoster, measles, mumps, and rubella Exclusion Criteria: Received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity Received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to receive them during the course of the study History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™ Received salicylates within 14 days prior to study vaccination Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination History of seizure disorder, including febrile seizure Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination History of thrombocytopenia Born to a human immunodeficiency virus (HIV)-infected mother Participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment.
    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
    29087781
    Citation
    Senders SD, Bundick ND, Li J, Zecca C, Helmond FA. Evaluation of immunogenicity and safety of VARIVAX New Seed Process (NSP) in children. Hum Vaccin Immunother. 2018 Feb 1;14(2):442-449. doi: 10.1080/21645515.2017.1388479. Epub 2017 Dec 11.
    Results Reference
    result

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    Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)

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