ProQuad Dose Selection Study (V221-011)(COMPLETED)

Overview

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

Full Title of Study: “A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2000

Interventions

  • Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
    • a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
  • Biological: Comparator: M-M-R II
    • A single 0.5 mL subcutaneous injection at Day 0
  • Biological: Comparator: PUVV
    • A single 0.5 mL subcutaneous injection at Day 0

Arms, Groups and Cohorts

  • Experimental: 1
    • ProQuad (low dose)
  • Experimental: 2
    • ProQuad (middle dose)
  • Experimental: 3
    • ProQuad (high dose)
  • Active Comparator: 4
    • M-M-R II + PUVV

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
    • Time Frame: 6 weeks postvaccination
    • Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units

Secondary Measures

  • Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL
    • Time Frame: 6 weeks postvaccination
    • Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline
  • Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL
    • Time Frame: 6 weeks Postvaccination
    • Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 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 in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline
  • Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
    • Time Frame: 6 weeks Postvaccination Visit 1 or Visit 2
    • Participants 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).
  • Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units – Geometric Mean Titer (GMT)
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)
  • Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline – Geometric Mean Titer (GMT)
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)
  • Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline – Geometric Mean Titer (GMT)
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)
  • Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline – Geometric Mean Titer (GMT)
    • Time Frame: 6 weeks postvaccination
    • Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)

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
  • Immune globulin or any blood product administered in the past 3 months

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

Shinefield H, Black S, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, Schödel F, Kuter BJ; Dose Selection Study Group for Proquad. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):670-5. Erratum in: Pediatr Infect Dis J. 2005 Nov;24(11):983.

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