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

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

Completed

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Key information

Conditions

Measles Chickenpox DNA Virus Infections Herpesviridae Infections Infections Mononegavirales Infections Morbillivirus Infections Mouth Diseases Mumps Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubella Rubivirus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Togaviridae Infections Varicella Varicella Zoster Virus Infection Virus Diseases

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

0.5 mL subcutaneous injection of one of three sub-lots on Day 0

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

Biological

0.5 mL subcutaneous injection on Day 0

Primary outcomes

Neutralizing antibodies to mumps at 6 weeks postvaccination

Time frame: 6 weeks postvaccination

Secondary outcomes

Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination

Time frame: 6 weeks and 1 year postvaccination

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age

Important dates

Study start: 1999
Primary completion: 2001
Study completion: 2001
First posted: Sep 27, 2004
Registry last updated: Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed