Status:
COMPLETED
Safety and Immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine in Children Receiving Solid Organ Transplants
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Organ Transplant
Immunosuppression
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief Summary
We plan to study whether the 7-valent pneumococcal conjugate vaccine (Prevnar™) is safe and effective in protecting children who have had a solid organ transplantation and healthy children from pneumo...
Detailed Description
Solid organ transplantation (SOT) has emerged as a lifesaving therapy for many patients with end organ failure. SOT recipients have a lifelong increased risk for infections as a result of immunosuppre...
Eligibility Criteria
Inclusion
- Transplant recipients:
- Children 4 months of age up to 18 years of age
- received a kidney, liver, heart, lung or other solid organ transplantation in a Canadian transplant centre
- Informed consent obtained
- Healthy Infants and Children:
- Children 2 months to 9 years of age
- no underlying chronic medical conditions
- Informed consent obtained
Exclusion
- Previous immunization with pneumococcal vaccine.
- Known hypersensitivity to any of the components of the vaccine, including diphtheria toxoid. Besides the saccharides and CRM197 carrier protein, the vaccine contains aluminum phosphate adjuvant.
- Any significant infection and/or fever at the time of vaccination
- Major acute illness such as clinical instability and acute graft rejection
- Latex allergy
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2017
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00213265
Start Date
July 1 2002
End Date
February 1 2017
Last Update
February 15 2021
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8