ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)

A Pilot Study to Compare the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine and the Concomitant Administration of the Currently Licensed VARIVAX™ and M-M-R II™ in Healthy Children

This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 480
• 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:

• In good health
• Negative clinical history of varicella, shingles, measles, mumps, and rubella

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
• Immune globulin or any blood product administered in the past 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; ProQuad™ (V221) + Placebo Followed by ProQuad™	Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90; Other Names: ProQuad™; Biological: Comparator: Placebo; a single 0.5 mL subcutaneous placebo injection at Day 0
Active Comparator: 2; M-M-R™ II + VARIVAX™	Biological: Comparator: Varivax; a single 0.5 mL subcutaneous injection of Varivax at Day 0; Biological: Comparator: M-M-R II; a single 0.5 mL subcutaneous injection of M-M-R II at Day 0

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline	Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of <0.6 gpELISA units/mL) to Varicella at Baseline	6 weeks Postvaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL	Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <207.8 mIU/mL) to Measles at Baseline	6 weeks Postvaccination
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline	Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA units/mL at Baseline	6 weeks Postvaccination
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL	Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <2.0 Ab Units/mL) to Mumps at Baseline	6 weeks Postvaccination
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL	Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer <10 IU/mL) to Rubella at Baseline	6 weeks Postvaccination

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Shinefield H, Black S, Digilio L, Reisinger K, Blatter M, Gress JO, Brown ML, Eves KA, Klopfer SO, Schodel F, Kuter BJ. Evaluation of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):665-9. doi: 10.1097/01.inf.0000172902.25009.a1.

Study record dates

Study Major Dates

• Study Start: March 1, 1998
• Primary Completion (Actual): January 1, 1999
• Study Completion (Actual): June 1, 1999

Study Registration Dates

• First Submitted: September 10, 2009
• First Submitted That Met QC Criteria: September 10, 2009
• First Posted (Estimate): September 11, 2009

Study Record Updates

• Last Update Posted (Estimate): October 6, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• 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: V221-009; 2009_660