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

Merck Sharp & Dohme (MSD)

Status and phase

Terminated

Phase 3

Conditions

Rubella

Varicella

Mumps

Measles

Treatments

Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)

Biological: M-M-R™ II and Varivax™

Study type

Interventional

Funder types

Industry

Identifiers

NCT00839917

2009_538

V221-023

Details and patient eligibility

About

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™.

Enrollment

30 patients

Sex

All

Ages

12 to 23 months old

Volunteers

Accepts Healthy Volunteers

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)