The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Upton Allen, The Hospital for Sick Children
First received: September 14, 2005
Last updated: August 15, 2013
Last verified: August 2013
We hypothesize that children listed to undergo solid organ transplant will experience (at the very most) a low rate (< 5%) of serious vaccine-related adverse events within 42 days after immunization with live attenuated Oka/Merck varicella vaccine (VARIVAX™). We also hypothesize that the immunogenicity of two doses of VARIVAX™ in the study population will be similar to historical data in healthy subjects and that the efficacy of two doses of the vaccine in the study population will be similar to that of healthy subjects.
Biological: varicella vaccine (VARIVAX)
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Safety and Immunogenicity of Live Attenuated Oka/Merck Varicella Vaccine in Children Listed to Undergo Solid Organ Transplantation
Primary Outcome Measures:
- Determination of the safety of VARIVAX™ administrated as two-dose regimen to the study population
- Determination of the proportion of study subjects immunized who demonstrate seroconversion and maintain humoral immunity seroconversion at 6, 12 and 24 months post-transplantation
- Determination of the extent to which cellular immune responses are maintained at 6, 12 and 24 months post-transplantation
Secondary Outcome Measures:
- The efficacy of VARIVAX™ as indicated by the incidence of clinical varicella or zoster over the 2 years following immunization
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||9 Months to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00213304
|The Hospital for Sick Children
|Toronto, Ontario, Canada, M5G 1X8 |
The Hospital for Sick Children
||Upton Allen, MD
||The Hospital for Sick Children, Toronto Canada
||The Hospital for Sick Children
No publications provided
||Upton Allen, Chief, Division of Infectious Diseases, The Hospital for Sick Children
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 14, 2005
||August 15, 2013
||Canada: Health Canada
Keywords provided by The Hospital for Sick Children:
ClinicalTrials.gov processed this record on September 18, 2014