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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092391

Enrollment

1997

Registered

2004-09-27

Start date

1999-02-28

Completion date

2001-07-31

Last updated

2015-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measles, Mumps, Rubella, Varicella

Brief summary

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

Interventions

BIOLOGICALComparator: 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

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

0.5 mL subcutaneous injection on Day 0

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Months to 18 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Neutralizing antibodies to mumps at 6 weeks postvaccination	6 weeks postvaccination

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026