Clinical trial NCT00985153: Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)
Official title: Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Measles
Mumps
Rubella
Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-09-28
Enrollment: 3927
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.


Eligibility criteria: Inclusion Criteria:

* In good health
* Negative clinical history of measles, mumps, rubella, varicella, and zoster

Exclusion Criteria:

* Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
* Any immune impairment or deficiency
* 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

Primary outcomes:
measure: Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL
timeFrame: 6 weeks Postvaccination
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: Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer
timeFrame: 6 weeks Postvaccination
measure: Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer
timeFrame: 6 weeks Postvaccination
measure: Number of Participants With Serious Vaccine-related CAEs
timeFrame: 6 weeks Postvaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, Klopfer S, Schodel F, Kuter BJ; Consistency Lot Study Group for ProQuad. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody. Pediatr Infect Dis J. 2006 Jul;25(7):615-22. doi: 10.1097/01.inf.0000220209.35074.0b.