Clinical trial NCT00839917: A Study of ProQuad™ in Healthy Children in Korea (V221-023)
Official title: A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Measles
Mumps
Rubella
Varicella
Keywords: Measles
Mumps
Rubella
Varicella
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-02-10
Enrollment: 30
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 ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be non-inferior to the antibody response rates after vaccination with concomitant M-M-R™ II and Varivax™.


Eligibility criteria: Inclusion Criteria:

* Subject is in good health
* Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Exclusion Criteria:

* Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
* Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
* Subject has a history of seizure disorder
* Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
* Subject has received an inactivated vaccine within the past 14 days
* Subject has received a live vaccine within the past 30 days
* Subject has received immune globulin within the past 5 months
* Subject has a recent history of fever (within the last 72 hours)

Primary outcomes:
measure: Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
timeFrame: 6 weeks postvaccination
measure: Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
timeFrame: 6 weeks postvaccination
measure: Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
timeFrame: 6 weeks postvaccination
measure: Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
timeFrame: 6 weeks postvaccination
Secondary outcomes:
measure: Geometric Mean Titer of Measles Antibodies
timeFrame: 6 weeks postvaccination
measure: Geometric Mean Titer of Mumps Antibodies
timeFrame: 6 weeks postvaccination
measure: Geometric Mean Titer of Rubella Antibodies
timeFrame: 6 weeks postvaccination
measure: Geometric Mean Titer of VZV (gpELISA) Antibodies
timeFrame: 6 weeks postvaccination
Other outcomes:
measure: Percentage of Participants With Measles-like Rash
timeFrame: Through 6 weeks postvaccination
measure: Percentage of Participants With Varicella-like Rash
timeFrame: Through 6 weeks postvaccination
measure: Percentage of Participants With Rubella-like Rash
timeFrame: Through 6 weeks postvaccination
measure: Percentage of Participants With Zoster-like Rash
timeFrame: Through 6 weeks postvaccination
measure: Percentage of Participants With Any Systemic Adverse Experience
timeFrame: Through 6 weeks postvaccination
measure: Percentage of Participants With Injection-site Adverse Experiences
timeFrame: Through 6 weeks postvaccination
measure: Percentage of Participants With Injection-site Adverse Experiences
timeFrame: Through 5 days postvaccination
measure: Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal)
timeFrame: Through 6 weeks postvaccination
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: