Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines

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

Official Title
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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

Conditions
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Measles, Mumps, Rubella, Varicella

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ProQuad + Tripedia + Comvax at Day 0 (Concomitant) | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live<br>* A single 0.5 mL subcutaneous injection at Day 0<br>* Other names: ProQuad;Biological: Comparator: Tripedia<br>* A single 0.5 mL intramuscular injection (at Day 0 or Day 42)<br>Biological: Comparator: Comvax<br>* A single 0.5 mL intramuscular injection (at Day 0 or Day 42)<br>|
| Experimental: 2<br>ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant) | Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live<br>* A single 0.5 mL subcutaneous injection at Day 0<br>* Other names: ProQuad;Biological: Comparator: Tripedia<br>* A single 0.5 mL intramuscular injection (at Day 0 or Day 42)<br>Biological: Comparator: Comvax<br>* A single 0.5 mL intramuscular injection (at Day 0 or Day 42)<br>|
| Active Comparator: 3<br>Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control) | Biological: Comparator: Tripedia<br>* A single 0.5 mL intramuscular injection (at Day 0 or Day 42)<br>Biological: Comparator: Comvax<br>* A single 0.5 mL intramuscular injection (at Day 0 or Day 42)<br>Biological: Comparator: Varivax<br>* A single 0.5 mL subcutaneous injection at Day 0<br>Biological: Comparator: M-M-R II<br>* A single 0.5 mL subcutaneous injection at Day 0<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 Weeks Postvaccination | 
| 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 | 6 weeks Postvaccination | 
| 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 | 6 weeks Postvaccination | 
| 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 | 6 weeks Postvaccination | 
| Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL | Antibody response to Diphtheria at 6 weeks postvaccination | 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. | 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). | 6 weeks Postvaccination | 
| 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). | 6 weeks Postvaccination | 
| 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)). | 6 weeks Postvaccination | 
| 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.) | 6 weeks Postvaccination | 
| 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.) | 6 weeks Postvaccination | 
| 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.) | 6 weeks Postvaccination | 
| 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.) | 6 weeks Postvaccination | 
| 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.) | 6 weeks Postvaccination | 
| 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.) | 6 weeks Postvaccination | 
| 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). | 6 weeks Postvaccination | 
| 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).) | 6 weeks Postvaccination | 
| 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).) | 6 weeks Postvaccination | 
| 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.) | 6 weeks Postvaccination | 
| 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).) | 6 weeks Postvaccination |