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Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00984295
First received: September 23, 2009
Last updated: April 21, 2010
Last verified: April 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Measles
Mumps
Rubella
Varicella
 Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
Biological: Comparator: Tripedia
Biological: Comparator: Comvax
Biological: Comparator: Varivax
Biological: Comparator: M-M-R II
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL [ Time Frame: 6 Weeks Postvaccination ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Postvaccination Observed Geometric Mean Titer of Antibody to Tetanus. (Titers of tetanus antitoxin were measured with an indirect, noncompetitive enzyme immunoassay (EIA).)


Enrollment: 1913
Study Start Date: June 2000
Study Completion Date: December 2001
Primary Completion Date: October 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ProQuad + Tripedia + Comvax at Day 0 (Concomitant)
 Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A single 0.5 mL subcutaneous injection at Day 0
Other Name: ProQuad
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)
Experimental: 2
ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant)
 Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A single 0.5 mL subcutaneous injection at Day 0
Other Name: ProQuad
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)
Active Comparator: 3
Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control)
 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

  Eligibility

Ages Eligible for Study:   12 Months to 15 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984295

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00984295     History of Changes
Other Study ID Numbers: 2009_666, V221-013
Study First Received: September 23, 2009
Results First Received: February 3, 2010
Last Updated: April 21, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chickenpox
Herpes Zoster
Measles
Mumps
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections
 Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on May 22, 2013