NCT00156559

Brief Summary

This research is designed to address the question, "Does the relative deficit in vaccine immunogenicity in extremely premature infants persist beyond the first 6 months of life?" We propose to measure the immunogenicity of varicella and mumps-measles-rubella vaccines in relatively healthy, 12-to-15 month-old children born at \<29 weeks gestation, when compared to full-term infants, as measured by the relevant viral serologies.

Trial Health

87
On Track

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 Jan 2004

Geographic Reach
1 country

1 active site

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

January 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

First QC Date

September 8, 2005

Last Update Submit

September 15, 2015

Conditions

Keywords

immunizationvaccinelow birth weight infantpremature infant

Eligibility Criteria

Age12 Months - 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

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • D'Angio CT, Boohene PA, Mowrer A, Audet S, Menegus MA, Schmid DS, Beeler JA. Measles-mumps-rubella and varicella vaccine responses in extremely preterm infants. Pediatrics. 2007 Mar;119(3):e574-9. doi: 10.1542/peds.2006-2241.

MeSH Terms

Conditions

ChickenpoxRubellaMeaslesMumpsPremature Birth

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsRubivirus InfectionsTogaviridae InfectionsRNA Virus InfectionsMorbillivirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRubulavirus InfectionsParotitisParotid DiseasesSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Carl T. D'Angio, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

January 1, 2004

Study Completion

May 1, 2005

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations