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

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

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™.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ProQuad™	Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™); Single administration of 0.5 mL subcutaneous injection; Other Names: V221
Active Comparator: M-M-R™ II and Varivax™	Biological: M-M-R™ II and Varivax™; Single administration of 0.5 mL subcutaneous injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Measles-like Rash		Through 6 weeks postvaccination
Percentage of Participants With Varicella-like Rash		Through 6 weeks postvaccination
Percentage of Participants With Rubella-like Rash		Through 6 weeks postvaccination
Percentage of Participants With Zoster-like Rash		Through 6 weeks postvaccination
Percentage of Participants With Any Systemic Adverse Experience	An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. A systemic adverse experience is any adverse experience other than injection-site adverse experiences.	Through 6 weeks postvaccination
Percentage of Participants With Injection-site Adverse Experiences	An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.	Through 6 weeks postvaccination
Percentage of Participants With Injection-site Adverse Experiences	An adverse experience is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study drug is also an adverse experience. An injection-site adverse experience is an adverse experience that occurs at the injection site only.	Through 5 days postvaccination
Percentage of Participants With Fever (≥101.0°F [38.3°C] Axillary or ≥103.0°F [39.4°C] Rectal)		Through 6 weeks postvaccination

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 9, 2009
• First Posted (Estimate): February 10, 2009

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Measles; Varicella; Mumps; Rubella
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; DNA Virus Infections; Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Togaviridae Infections; Rubivirus Infections; Measles; Herpes Zoster; Chickenpox; Rubella
• Other Study ID Numbers: V221-023; 2009_538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php