The Safety of Oka Varicella in Children Prior to Solid Organ Transplantation
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00213304
Verified August 2013 by Upton Allen, The Hospital for Sick Children. Recruitment status was: Active, not recruiting
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
9 Months to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.