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
About this trial
This is an interventional prevention trial for Measles
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
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
NCT ID
NCT00984295
First Posted
September 23, 2009
Last Updated
July 16, 2015
Sponsor
Merck Sharp & Dohme LLC
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
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