Status:
COMPLETED
Evaluation of Pandemic Influenza A (H1N1) Vaccine in Chronic and or Immunocompromised Patients, Elderly and Pregnants
Lead Sponsor:
Butantan Institute
Collaborating Sponsors:
University of Sao Paulo
Insituto Adolfo Lutz
Conditions:
Immunocompromised Patients
Safety of Pandemic Influenza A (H1N1)Vaccine
Eligibility:
All Genders
6-90 years
Brief Summary
The objective of this study is to describe the safety and immunogenicity of a non-adjuvanted vaccine against pandemic influenza A (H1N1)in patients with chronic and or immunocompromised disease, elder...
Eligibility Criteria
Inclusion
- Volunteers able to understand and agree to participate in the study.
Exclusion
- Have egg allergy
- Have past history of allergy to seasonal influenza vaccine
- Have received another inactivated vaccine within the prior 2 weeks or live vaccine in the past four weeks to his/her participation in the study
- Acute infectious disease during seven days prior vaccination
- Confirmed prior infection by pandemic influenza A (H1N1)
- Have participated in another clinical trial in the last 6 months
- Any other condition identified by the principal investigators which is considered not safe for enrollment of the volunteer.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
1152 Patients enrolled
Trial Details
Trial ID
NCT01218685
Start Date
April 1 2010
End Date
April 1 2011
Last Update
February 6 2013
Active Locations (1)
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1
Avenida Vital Brasil 1500
São Paulo, São Paulo, Brazil, 05503-900