NCT00138255

Brief Summary

The purpose of this study is to see if the MMR and chickenpox vaccines work as well in premature infants as in children that were carried to full term. A group of children who were carried full-term will be matched for age, sex, and race and will be used for comparison.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
Last Updated

August 27, 2010

Status Verified

May 1, 2005

First QC Date

August 26, 2005

Last Update Submit

August 26, 2010

Conditions

MeaslesMumpsRubellaVaricella

Eligibility Criteria

AgeUp to 16 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Premature infant \< 29 weeks gestation at birth or term infant \>= 37 weeks gestation at birth.
  • Postnatal age \< 16 months, 0 days.
  • Has not yet received MMR or varicella vaccines. (There are no restrictions on the administration of other vaccines at the time of MMR/varicella vaccination.)
  • Parental permission.
  • Agreement of primary care pediatrician/ health care provider.
  • Receives primary pediatric care within an approximate 25-mile radius of the University of Rochester.
  • Healthy status at enrollment.

You may not qualify if:

  • Known immunodeficiency.
  • Systemic corticosteroid therapy at the time of MMR/varicella vaccination.
  • Requiring oxygen therapy.
  • Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester School of Medicine and Dentistry

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

MeaslesMumpsRubellaChickenpox

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 30, 2005

Study Start

June 1, 2004

Study Completion

June 1, 2005

Last Updated

August 27, 2010

Record last verified: 2005-05

Locations

US(1)