Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

Overview

This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.

Full Title of Study: “An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of Frozen MMRV Given Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines in Healthy Children 12 to 15 Months of Age”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 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: Tripedia
    • A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
  • Biological: Comparator: Comvax
    • A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
  • 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 + Tripedia + Comvax at Day 0 (Concomitant)
  • Experimental: 2
    • ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant)
  • Active Comparator: 3
    • Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Participants 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 Participants 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 Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline
  • Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL
    • Time Frame: 6 weeks Postvaccination
    • Antibody Response to Varicella-Zoster Virus (VZV) at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <0.6 gpELISA units/mL) to VZV at Baseline
  • Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL
    • Time Frame: 6 weeks Postvaccination
    • Antibody response to Diphtheria at 6 weeks postvaccination
  • Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL
    • Time Frame: 6 weeks Postvaccination
    • Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.
  • Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer
    • Time Frame: 6 weeks Postvaccination
    • Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).
  • Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer
    • Time Frame: 6 weeks Postvaccination
    • Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).
  • Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL
    • Time Frame: 6 weeks Postvaccination
    • Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).
  • Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL
    • Time Frame: 6 weeks Postvaccination
    • Antibody response to Haemophilus influenzae type B (Hib). (Anti-polyribosylribitol phosphate (PRP) was measured by radioimmunoassay (RIA) using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
  • Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline – Geometric Mean Titer (GMT)
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)
  • Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline – GMT
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)
  • Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline – GMT
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)
  • Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline – GMT
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)
  • Antibody Response to Diphtheria at 6 Weeks Postvaccination – GMT
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)
  • Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination – GMT
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).
  • Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination – GMT
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)
  • Antibody Response to Hepatitis B at 6 Weeks Postvaccination – GMT
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)
  • Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination – GMT
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination observed GMT of antibody to Hib. (Anti-polyribosylribitol phosphate (PRP) was measured by RIA using radiolabeled-PRP according to a standard Farr technique and with a standard provided by the U.S. FDA.)
  • Antibody Response to Tetanus at 6 Weeks Postvaccination – GMT
    • Time Frame: 6 weeks Postvaccination
    • Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)

Participating in This Clinical Trial

Inclusion Criteria

  • In good health
  • Negative clinical history of varicella, zoster, measles, mumps, rubella, diptheria, tetanus, pertussis, invasive Hib disease and hepatitis B
  • Had completed either a 2-dose primary series of PedvaxHIB or COMVAX or any 3-dose primary series of a licensed Hib vaccine
  • Had received 2 or 3 doses of any hepatitis B vaccine or COMVAX prior to entry into trial

Exclusion Criteria

  • Previous receipt of measles, mumps, rubella or varicella vaccine either alone or in combination
  • Any immune impairment or deficiency
  • Recent household, daycare or school exposure to invasive Hib disease or hepatitis B
  • 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
  • Receipt of immune globulin, blood transfusion or blood-derived product in the past 3 months
  • Recent history of fever or underlying medical problems

Gender Eligibility: All

Minimum Age: 12 Months

Maximum Age: 15 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, Thear M, Coury D, Reisinger K, Rothstein E, Xu J, Hartzel J, Evans B, Digilio L, Schödel F, Brown ML, Kuter B; 013 Study Group for ProQuad. Safety and immunogenicity of a measles, mumps, rubella and varicella vaccine given with combined Haemophilus influenzae type b conjugate/hepatitis B vaccines and combined diphtheria-tetanus-acellular pertussis vaccines. Pediatr Infect Dis J. 2006 Apr;25(4):287-92.

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