Clinical trial NCT00984295: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles
Mumps
Rubella
Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-25
Enrollment: 1913
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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

Primary outcomes:
measure: Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥120 mIU/mL
timeFrame: 6 Weeks Postvaccination
measure: Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With Postvaccination Varicella-Zoster Virus (VZV) Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥5 gpELISA Units/mL
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With Postvaccination Diphtheria Vero Cell Culture Assay Antibody Titer ≥0.1 IU/mL
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With Postvaccination Tetanus Enzyme Immunoassay (EIA) Antibody Titer ≥0.1 IU/mL
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With ≥4-fold Rise in Pertussis Toxin (PT) EIA Antibody Titer
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With ≥4-fold Rise in Pertussis Filamentous Hemagglutinin (FHA) EIA Antibody Titer
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With Postvaccination Hepatitis B (Quantitative AUSAB™ Radioimmunoassay (RIA)) Antibody Titer ≥10 mIU/mL
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With Postvaccination Haemophilus Influenzae Type B (Hib) Radioimmunoassay (RIA) Antibody Titer ≥ 1 mcg/mL
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Measles at 6 Weeks Postvaccination for Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Mumps at 6 Weeks Postvaccination for Participants Initially Seronegative to Mumps at Baseline - GMT
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Rubella at 6 Weeks Postvaccination for Participants Initially Seronegative to Rubella at Baseline - GMT
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Varicella at 6 Weeks Postvaccination for Participants Initially Seronegative to Varicella at Baseline - GMT
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Diphtheria at 6 Weeks Postvaccination - GMT
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Pertussis Toxin (PT) at 6 Weeks Postvaccination - GMT
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Pertussis Filamentous Hemagglutinin (FHA) at 6 Weeks Postvaccination - GMT
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Hepatitis B at 6 Weeks Postvaccination - GMT
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Haemophilus Influenzae Type B (Hib) at 6 Weeks Postvaccination - GMT
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Tetanus at 6 Weeks Postvaccination - GMT
timeFrame: 6 weeks Postvaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
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.