NCT00109278

Brief Summary

The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,100

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2004

Shorter than P25 for phase_2

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

October 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2005

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 26, 2005

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

April 26, 2005

Last Update Submit

March 14, 2017

Conditions

Measles

Keywords

Prevention of Measles

Outcome Measures

Primary Outcomes (1)

  • Antibody response rate to measles at 6 weeks postvaccination

Secondary Outcomes (1)

  • Geometric mean titers to measles by ELISA at 6 weeks postvaccination

Interventions

V205C, measles, mumps, and rubella virus vaccine liveBIOLOGICAL
Comparator: Measles, Mumps, and Rubella Virus Vaccine LiveBIOLOGICAL

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:

  • Previous receipt of measles, mumps, rubella and/or varicella vaccine.
  • Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster.
  • Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy.
  • History of seizures (convulsions)
  • Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin.
  • A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F \[37.5° C\]).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Measles

Interventions

Rubella Vaccine

Condition Hierarchy (Ancestors)

Morbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2005

First Posted

April 26, 2005

Study Start

October 1, 2004

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

March 15, 2017

Record last verified: 2017-03