A Study of ProQuad™ in Healthy Children in Korea (V221-023)

Phase 3

Terminated

• Conditions: Varicella; Rubella; Measles; Mumps
• Interventions: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™); Biological: M-M-R™ II and Varivax™

• Registration Number: NCT00839917
• Lead Sponsor: Merck Sharp & Dohme LLC

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™.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-09
• Study First Posted: 2009-02-10
• Results First Submitted: 2012-09-07
• Results First Submitted QC: 2012-09-07
• Results First Posted: 2012-10-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-15
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ProQuad™	Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)	-
M-M-R™ II and Varivax™	M-M-R™ II and Varivax™	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL	6 weeks postvaccination	Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (\<255 mIU/mL) to measles at baseline
Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL	6 weeks postvaccination	Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (\<10 units/mL) to mumps at baseline
Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL	6 weeks postvaccination	Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (\<10 IU/mL) to rubella at baseline
Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL	6 weeks postvaccination	Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (\<5 gpELISA units/mL) to VZV at baseline

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titer of Measles Antibodies	6 weeks postvaccination	Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (\<255 mIU/mL) to measles at baseline
Geometric Mean Titer of Mumps Antibodies	6 weeks postvaccination	Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (\<10 Units/mL) to mumps at baseline
Geometric Mean Titer of Rubella Antibodies	6 weeks postvaccination	Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (\<10 IU/mL) to rubella at baseline
Geometric Mean Titer of VZV (gpELISA) Antibodies	6 weeks postvaccination	Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (\<5 gpELISA Units/mL) to VZV at baseline