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Evaluation of the Safety of Varivax® in Pediatric Renal Transplant Recipients

NCT00005009 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-02-16

No results posted yet for this study

Summary

The purpose of this study is to find out whether Varivax is safe for use in children with kidney transplants and whether it protects children from serious infection. Varivax is a vaccine against varicella zoster virus (VZV), the virus that causes chickenpox (varicella) and shingles (zoster).

Healthy children are already receiving Varivax shots to protect them from chickenpox. Few children with kidney transplants have received Varivax because doctors have been concerned that Varivax might cause serious reactions in them. On the other hand, VZV infection can be a life-threatening disease in these children. For this reason, doctors ultimately want to learn whether Varivax might safely prevent VZV infections in children who have had kidney transplants.

Conditions

  • Kidney Transplant Recipients

Interventions

BIOLOGICAL

Varivax®

Each participant will receive 2 doses of Varivax 6 to 8 weeks apart.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Cooperative Clinical Trials in Pediatric Transplantation

    collaborator NETWORK

  • North American Pediatric Renal Trials and Collaborative Studies (NAPRTCS)

    collaborator UNKNOWN

  • NIAID Vaccine and Treatment Evaluation Units (VTEUs)

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Amir Tejani, MD · North American Pediatric Renal Transplantation Study (NAPRTCS)

  • Beverly L. Connelly, MD · Vaccine and Treatment Evaluation Unit (VTEU)-Cincinnati Children's

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1998-02-28
Primary Completion
2001-06-16
Completion
2001-06-16

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005009 on ClinicalTrials.gov