Status:
COMPLETED
The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Organ Transplantation
Immunosuppression
Eligibility:
All Genders
9-18 years
Phase:
PHASE3
Brief Summary
This study sought to determine the safety of the varicella vaccine pre- and post-transplantation when given to pediatric patients listed for solid organ transplantation. The study assessed the antibod...
Eligibility Criteria
Inclusion
- Children \> 9 months of age and adolescents \< 18 years of age.
- Pediatric transplant candidates who are in any of the following categories:
- listed to receive kidney, liver, heart, lung or other or solid organ transplantation in a Canadian transplant centre
- not yet officially listed, but are regarded by their physicians as transplant candidates by virtue of their underlying diseases
- No clinical history for varicella.
- Seronegative for antibodies to VZV except infants 9 - 12 months of age who may be seropositive due to maternal antibodies.
- Informed consent obtained
Exclusion
- Previous immunization with varicella vaccine.
- Any established immune deficiency (underlying disease or drug induced) or any neoplastic disease
- Children on any oral and / or intravenous steroids within 3 months prior to immunization. Children on inhaled corticosteroids in excess of 800 mcg of beclomethasone dipropionate ( or equivalent ) per day.
- Any exposure to varicella or herpes zoster in the previous 4 weeks involving household, playmate or hospital contacts.
- Inability to delay the transplantation for up to 6 weeks following the last varicella immunization.
- Presence of a person at increased risk for varicella infection in direct and unavoidable proximity with the vaccinees ( e.g. an immunocompromised sibling)
- Past history of varicella or known positive antibody titer for varicella except infants 9 - 12 months of ages who may be seropositive due to maternal antibodies
- Known hypersensitivity to any of the components of the vaccine, including neomycin and gelatin
- Patients whose mothers are known to be seronegative and plan to become pregnant in the subsequent three months
- Administration of VZIG or any other blood products in the previous six weeks (packed red blood cells excepted).
- Any significant infection and/or fever at the time of vaccination
- Any patient receiving or planning to receive salicylates in the six weeks after immunization
- Any patient who has received any live vaccine for 6 weeks or killed vaccine for 2 weeks prior to or after the scheduled VARIVAX™ vaccination.
Key Trial Info
Start Date :
June 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00213304
Start Date
June 1 1999
End Date
December 1 2016
Last Update
August 24 2021
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8