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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092391
First Posted: September 27, 2004
Last Update Posted: October 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The purpose of this study is to determine the mumps virus strength at the end of shelf-life (expiration date) of an approved vaccine.

Condition Intervention Phase
Measles Mumps Rubella Varicella Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Study of M-M-R(TM) II at Mumps Expiry Potency in Healthy Children 12 to 18 Months of Age

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Neutralizing antibodies to mumps at 6 weeks postvaccination [ Time Frame: 6 weeks postvaccination ]

Secondary Outcome Measures:
  • Geometric mean titers to mumps by ELISA at 6 weeks and at 1 year postvaccination [ Time Frame: 6 weeks and 1 year postvaccination ]

Enrollment: 1997
Study Start Date: February 1999
Study Completion Date: July 2001
Primary Completion Date: July 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Group
M-M-R(TM) II at current release potency
Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0
Experimental: Mumps Expiry Group 1
M-M-R(TM) II at intermediate expiry potency
Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0
Experimental: Mumps Expiry Group 2
M-M-R(TM) II at expiry potency
Biological: Comparator: M-M-R(TM) II, measles, mumps, and rubella virus vaccine live
0.5 mL subcutaneous injection of one of three sub-lots on Day 0
Biological: Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)
0.5 mL subcutaneous injection on Day 0

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Months to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092391


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092391     History of Changes
Other Study ID Numbers: V205C-007
2004_073
First Submitted: September 22, 2004
First Posted: September 27, 2004
Last Update Posted: October 23, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Rubella
Mumps
Rubivirus Infections
Togaviridae Infections
RNA Virus Infections
Virus Diseases
Rubulavirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
Parotitis
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs