A Study of ProQuad™ in Healthy Children in Korea (V221-023)

Overview

This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.

Full Title of Study: “A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2008

Interventions

  • Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
    • Single administration of 0.5 mL subcutaneous injection
  • Biological: M-M-R™ II and Varivax™
    • Single administration of 0.5 mL subcutaneous injection

Arms, Groups and Cohorts

  • Experimental: ProQuad™
  • Active Comparator: M-M-R™ II and Varivax™

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
    • Time Frame: 6 weeks postvaccination
    • Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
  • Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
    • Time Frame: 6 weeks postvaccination
    • Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline
  • Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
    • Time Frame: 6 weeks postvaccination
    • Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
  • Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
    • Time Frame: 6 weeks postvaccination
    • Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline

Secondary Measures

  • Geometric Mean Titer of Measles Antibodies
    • Time Frame: 6 weeks postvaccination
    • Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
  • Geometric Mean Titer of Mumps Antibodies
    • Time Frame: 6 weeks postvaccination
    • Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline
  • Geometric Mean Titer of Rubella Antibodies
    • Time Frame: 6 weeks postvaccination
    • Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
  • Geometric Mean Titer of VZV (gpELISA) Antibodies
    • Time Frame: 6 weeks postvaccination
    • Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline

Participating in This Clinical Trial

Inclusion Criteria

  • Subject is in good health
  • Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Exclusion Criteria

  • Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
  • Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
  • Subject has a history of seizure disorder
  • Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
  • Subject has received an inactivated vaccine within the past 14 days
  • Subject has received a live vaccine within the past 30 days
  • Subject has received immune globulin within the past 5 months
  • Subject has a recent history of fever (within the last 72 hours)

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: 23 Months

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme Corp.

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