Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

Overview

This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.

Full Title of Study: “Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) in Healthy Children”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2001

Interventions

  • Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
    • A Single 0.5 mL subcutaneous injection at Day 0
  • Biological: Comparator: Varivax
    • A Single 0.5 mL subcutaneous injection at Day 0
  • Biological: Comparator: M-M-R II
    • A Single 0.5 mL subcutaneous injection at Day 0

Arms, Groups and Cohorts

  • Experimental: 1
    • ProQuad Lot 1
  • Experimental: 2
    • ProQuad Lot 2
  • Experimental: 3
    • ProQuad Lot 3
  • Active Comparator: 4
    • M-M-R II + Varivax

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL
    • Time Frame: 6 weeks Postvaccination
    • Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA units/mL at Baseline
  • Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL
    • Time Frame: 6 weeks Postvaccination
    • Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline
  • Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL
    • Time Frame: 6 weeks Postvaccination
    • Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 Ab units/mL) to Mumps at Baseline
  • Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
    • Time Frame: 6 weeks Postvaccination
    • Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 IU/mL) to Rubella at Baseline
  • Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline – Geometric Mean Titer
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination observed Geometric Mean Titer of antibody to Varicella
  • Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline – Geometric Mean Titer
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination observed Geometric Mean Titer of antibody to Measles.
  • Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline – Geometric Mean Titer
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination observed Geometric Mean Titer of antibody to Mumps.
  • Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline – Geometric Mean Titer
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination observed Geometric Mean Titer of antibody to Rubella
  • Number of Participants With Serious Vaccine-related CAEs
    • Time Frame: 6 weeks Postvaccination
    • Subjects with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).

Participating in This Clinical Trial

Inclusion Criteria

  • In good health
  • Negative clinical history of measles, mumps, rubella, varicella, and zoster

Exclusion Criteria

  • Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
  • Any immune impairment or deficiency
  • Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
  • Vaccination with an inactive vaccine with in the past 14 days
  • Vaccination with a live vaccine within the past 30 days

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.

Citations Reporting on Results

Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, Klopfer S, Schödel F, Kuter BJ; Consistency Lot Study Group for ProQuad. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody. Pediatr Infect Dis J. 2006 Jul;25(7):615-22.

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