NCT00092391

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,997

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 1999

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 22, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 27, 2004

Completed
Last Updated

October 23, 2015

Status Verified

October 1, 2015

Enrollment Period

2.4 years

First QC Date

September 22, 2004

Last Update Submit

October 22, 2015

Conditions

MeaslesMumpsRubellaVaricella

Outcome Measures

Primary Outcomes (1)

  • Neutralizing antibodies to mumps at 6 weeks postvaccination

    6 weeks postvaccination

Secondary Outcomes (1)

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

    6 weeks and 1 year postvaccination

Study Arms (3)

Control Group

ACTIVE COMPARATOR

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

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

Mumps Expiry Group 1

EXPERIMENTAL

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

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

Mumps Expiry Group 2

EXPERIMENTAL

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

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

Interventions

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

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

Control GroupMumps Expiry Group 1Mumps Expiry Group 2
Comparator: VARIVAX(TM) Varicella Virus Vaccine Live (Oka-Merck)BIOLOGICAL

0.5 mL subcutaneous injection on Day 0

Control GroupMumps Expiry Group 1Mumps Expiry Group 2

Eligibility Criteria

Age12 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children 12 to 18 months of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MeaslesMumpsRubellaChickenpox

Interventions

Rubella VaccineHerpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesRubivirus InfectionsTogaviridae InfectionsVaricella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus Infections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesChickenpox VaccineHerpesvirus Vaccines

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2004

First Posted

September 27, 2004

Study Start

February 1, 1999

Primary Completion

July 1, 2001

Study Completion

July 1, 2001

Last Updated

October 23, 2015

Record last verified: 2015-10