A Study of An Approved Vaccine at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age (V205C-007)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Rubella; Varicella; Mumps; Measles

Treatments: Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck); Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092391

2004_073

V205C-007

Details and patient eligibility

About

The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.

Enrollment: 1,997 patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children 12 to 18 months of age

Exclusion criteria

• History or prior exposure to measles, mumps, rubella or varicella
• History of anaphylactoid reactions or hypersensitivity to any component of the vaccine, including gelatin and neomycin

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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1,997 participants in 3 patient groups

Control Group

Active Comparator group

Description:

M-M-R(TM) II at current release potency

Treatment:

Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live

Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)

Mumps Expiry Group 1

Experimental group

Description:

M-M-R(TM) II at intermediate expiry potency

Treatment:

Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live

Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)

Mumps Expiry Group 2

Experimental group

Description:

M-M-R(TM) II at expiry potency

Treatment:

Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live

Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)