Status:
UNKNOWN
Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Varicella
Hepatitis A
Eligibility:
All Genders
13-30 years
Phase:
PHASE2
PHASE3
Brief Summary
This study aims to assess immunogenicity and safety of nd influence of the delivery system (needle-free injector or syringe with needle) of fractional doses (dose sparing) of two vaccines (Varicella a...
Detailed Description
The purpose of this study is to evaluate the immunogenicity, safety and influence of the delivery system (needle-free injector or syringe with needle) of fractional doses (dose sparing) (23,3 and 43,3...
Eligibility Criteria
Inclusion
- Children of both genders older than 13 months and younger than 30 months of age.
- Available for follow-up for at least 45 days at public day care centers funded by São Paulo City local government.
- Written informed consent signed by parents or legal guardians after reading and explanation
Exclusion
- Suspect/verified diagnosis of congenital or acquired immunodeficiency syndrome (AIDS)
- Suspect/verified diagnosis of malign neoplasia
- Children on treatment with high-dose systemic corticosteroids (equivalent to prednisone 2 mg/kg/day, for two or more weeks), or immunosuppressive therapy.
- Received a vaccine with live attenuated strain of virus within less than 30 days
- Suspect/verified diagnosis of chickenpox or has already been immunized against chickenpox (varicella).
- Suspect/verified diagnosis of hypersensibility to any ingredient of the vaccine.
- One of the parents or legal guardians of the minor does not agree with the study.
- Any other circumstances that may potentially damage the minor or prevent procedures from being carried out according to evaluation of the research team.
- Child shows signs or symptoms of an active intercurrent disease (e.g. fever, rash, etc.) that may interfere with the evaluation of adverse events after immunization at the research team's discretion. In this case, the participant may be reevaluated within the following three months in order to verify eligibility.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00926419
Start Date
June 1 2009
End Date
May 1 2010
Last Update
June 23 2009
Active Locations (1)
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1
Disciplina de Immunologia Clínica e Alergia do HC- FMUSP
São Paulo, São Paulo, Brazil, 05403-010