NCT00092430

Brief Summary

The purpose of this study is to demonstrate that an investigational refrigerated vaccine with measles, mumps, rubella, and varicella is well tolerated and has similar immune response when compared to a frozen vaccine with measles, mumps, rubella, and varicella.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,200

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_3

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

September 26, 2002

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2003

Completed
1.3 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

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

9 months

First QC Date

September 22, 2004

Last Update Submit

November 13, 2019

Conditions

MeaslesMumpsRubellaVaricella

Outcome Measures

Primary Outcomes (1)

  • Percent of patients demonstrating adequate antibody titers 6 weeks following administration

Secondary Outcomes (1)

  • Geometric mean titers (GMT) 6 weeks post vaccination

Interventions

V221, measles, mumps, rubella and varicella (Oka/Merck) virus vaccine live / Duration of Treatment: 12 weeksBIOLOGICAL

Eligibility Criteria

Age12 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children 12-23 months of age

You may not qualify if:

  • Previously had measles, mumps, rubella, or varicella
  • Compromised immune system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bernstein HH, Eves K, Campbell K, Black SB, Twiggs JD, Reisinger KS, Conti RM, Flodmark CE, Rombo L, Klopfer S, Schodel F, Hartzel J, Kuter BJ; Refrigerator-Stable Formulation Study Group for ProQuad. Comparison of the safety and immunogenicity of a refrigerator-stable versus a frozen formulation of ProQuad (measles, mumps, rubella, and varicella virus vaccine live). Pediatrics. 2007 Jun;119(6):e1299-305. doi: 10.1542/peds.2006-2283. Epub 2007 May 14.

    PMID: 17502347RESULT

MeSH Terms

Conditions

MeaslesMumpsRubellaChickenpox

Interventions

Duration of Therapy

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)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2004

First Posted

September 27, 2004

Study Start

September 26, 2002

Primary Completion

June 9, 2003

Study Completion

June 9, 2003

Last Updated

November 15, 2019

Record last verified: 2019-11