search
Back to results

Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

Primary Purpose

Measles, Mumps, Rubella

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Comparator: Tripedia
Comparator: Comvax
Comparator: Varivax
Comparator: 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 Measles

Eligibility Criteria

12 Months - 15 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    ProQuad + Tripedia + Comvax at Day 0 (Concomitant)

    ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant)

    Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control)

    Outcomes

    Primary Outcome Measures

    Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL
    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
    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
    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
    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
    Antibody response to Diphtheria at 6 weeks postvaccination
    Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL
    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
    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
    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
    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
    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)
    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
    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
    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
    Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)
    Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT
    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
    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
    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
    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
    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
    Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 2009
    Last Updated
    July 16, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00984295
    Brief Title
    Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
    Official Title
    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
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2000 (undefined)
    Primary Completion Date
    October 2001 (Actual)
    Study Completion Date
    December 2001 (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 assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1913 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    ProQuad + Tripedia + Comvax at Day 0 (Concomitant)
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant)
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control)
    Intervention Type
    Biological
    Intervention Name(s)
    Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
    Other Intervention Name(s)
    ProQuad
    Intervention Description
    A single 0.5 mL subcutaneous injection at Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Tripedia
    Intervention Description
    A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Comvax
    Intervention Description
    A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Varivax
    Intervention Description
    A single 0.5 mL subcutaneous injection at Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: M-M-R II
    Intervention Description
    A single 0.5 mL subcutaneous injection at Day 0
    Primary Outcome Measure Information:
    Title
    Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL
    Description
    Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <120 mIU/mL) to Measles at Baseline
    Time Frame
    6 Weeks Postvaccination
    Title
    Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
    Description
    Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 Ab units/mL) to Mumps at Baseline
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
    Description
    Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL
    Description
    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
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL
    Description
    Antibody response to Diphtheria at 6 weeks postvaccination
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL
    Description
    Antibody response to Tetanus (tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA)) at 6 weeks postvaccination.
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer
    Description
    Antibody response to Pertussis Toxin (titers of pertussis toxin antibodies were measured with an indirect, noncompetitive EIA).
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer
    Description
    Antibody response to pertussis FHA(titers of pertussis filamentous hemagglutinin antibodies were measured with an indirect, noncompetitive EIA).
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL
    Description
    Antibody response to Hepatitis B (titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA)).
    Time Frame
    6 weeks Postvaccination
    Title
    Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL
    Description
    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.)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
    Description
    Postvaccination Observed Geometric Mean Titer of Antibody to Measles. (Titers measured using Measles ELISA.)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT
    Description
    Postvaccination observed GMT of antibody to mumps. (Titers measured using mumps ELISA.)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT
    Description
    Postvaccination Observed Geometric Mean Titer of Antibody to Rubella. (Titers measured using Rubella ELISA.)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT
    Description
    Postvaccination Observed Geometric Mean Titer of Antibody to Varicella. (Titers measured using VZV gpELISA.)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT
    Description
    Postvaccination Observed Geometric Mean Titer of Antibody to Diphtheria. (Titers measured using Vero Cell Culture Assay.)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT
    Description
    Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Toxin (PT). Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT
    Description
    Postvaccination Observed Geometric Mean Titer of Antibody to Pertussis Filamentous Hemagglutinin (FHA). (Titers measured using an indirect, noncompetitive Pertussis enzyme immunoassay (EIA).)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT
    Description
    Postvaccination Observed Geometric Mean Titer of Antibody to Hepatitis B. (Titers measured using the Quantitative AUSAB™ radioimmunoassay (RIA).)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT
    Description
    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.)
    Time Frame
    6 weeks Postvaccination
    Title
    Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT
    Description
    Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)
    Time Frame
    6 weeks Postvaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    15 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16567978
    Citation
    Shinefield H, Black S, Thear M, Coury D, Reisinger K, Rothstein E, Xu J, Hartzel J, Evans B, Digilio L, Schodel 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. doi: 10.1097/01.inf.0000207857.10947.1f.
    Results Reference
    result

    Learn more about this trial

    Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

    We'll reach out to this number within 24 hrs