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

Phase 3

Completed

• Conditions: Mumps; Measles; Varicella; Rubella
• Interventions: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live

• Registration Number: NCT00975507
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-03
• Primary Completion: 1999-01
• Study Completion: 1999-06
• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Results First Submitted: 2009-09-23
• Results First Submitted QC: 2010-01-25
• Results First Posted: 2010-02-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-05
• Last Update Posted: 2015-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live	ProQuad™ (V221) + Placebo Followed by ProQuad™

Primary Outcome Measures

Name	Time	Method
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	6 weeks Postvaccination	Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline

Secondary Outcome Measures

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