Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
July 16, 2015 updated by: Merck Sharp & Dohme LLC
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
This study will assess the safety and immunogenicity of ProQuad when administered concomitantly and nonconcomitantly with Tripedia and Comvax.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
1913
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
ProQuad + Tripedia + Comvax at Day 0 (Concomitant)
|
A single 0.5 mL subcutaneous injection at Day 0
Other Names:
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
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)
|
A single 0.5 mL subcutaneous injection at Day 0
Other Names:
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
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)
|
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
A single 0.5 mL subcutaneous injection at Day 0
A single 0.5 mL subcutaneous injection at Day 0
|
What is the study measuring?
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
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
|
6 Weeks Postvaccination
|
|
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
|
6 weeks Postvaccination
|
|
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
|
6 weeks Postvaccination
|
|
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
|
6 weeks Postvaccination
|
|
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
|
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.
|
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).
|
6 weeks Postvaccination
|
|
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).
|
6 weeks Postvaccination
|
|
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)).
|
6 weeks Postvaccination
|
|
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.)
|
6 weeks Postvaccination
|
|
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.)
|
6 weeks Postvaccination
|
|
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.)
|
6 weeks Postvaccination
|
|
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.)
|
6 weeks Postvaccination
|
|
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.)
|
6 weeks Postvaccination
|
|
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.)
|
6 weeks Postvaccination
|
|
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).
|
6 weeks Postvaccination
|
|
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).)
|
6 weeks Postvaccination
|
|
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).)
|
6 weeks Postvaccination
|
|
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.)
|
6 weeks Postvaccination
|
|
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).)
|
6 weeks Postvaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2000
Primary Completion (ACTUAL)
October 1, 2001
Study Completion (ACTUAL)
December 1, 2001
Study Registration Dates
First Submitted
September 23, 2009
First Submitted That Met QC Criteria
September 24, 2009
First Posted (ESTIMATE)
September 25, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 7, 2015
Last Update Submitted That Met QC Criteria
July 16, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V221-013
- 2009_666
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.