Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
NCT ID: NCT00984295
Last Updated: 2015-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1913 participants
INTERVENTIONAL
2000-06-30
2001-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
ProQuad + Tripedia + Comvax at Day 0 (Concomitant)
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A single 0.5 mL subcutaneous injection at Day 0
Comparator: Tripedia
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
Comparator: Comvax
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
2
ProQuad at Day 0, Tripedia + Comvax at Day 42(Nonconcomitant)
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A single 0.5 mL subcutaneous injection at Day 0
Comparator: Tripedia
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
Comparator: Comvax
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
3
Varivax + M-M-R II at Day 0, Tripedia + Comvax at Day 42 (Control)
Comparator: Tripedia
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
Comparator: Comvax
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
Comparator: Varivax
A single 0.5 mL subcutaneous injection at Day 0
Comparator: M-M-R II
A single 0.5 mL subcutaneous injection at Day 0
Interventions
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Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
A single 0.5 mL subcutaneous injection at Day 0
Comparator: Tripedia
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
Comparator: Comvax
A single 0.5 mL intramuscular injection (at Day 0 or Day 42)
Comparator: Varivax
A single 0.5 mL subcutaneous injection at Day 0
Comparator: M-M-R II
A single 0.5 mL subcutaneous injection at Day 0
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Months
15 Months
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
References
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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.
Other Identifiers
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2009_666
Identifier Type: -
Identifier Source: secondary_id
V221-013
Identifier Type: -
Identifier Source: org_study_id
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