Status:
COMPLETED
Inactivated Influenza Vaccine Effectiveness in Tropical Africa
Lead Sponsor:
PATH
Collaborating Sponsors:
Institut de Recherche pour le Developpement
Institut Pasteur
Conditions:
Influenza
Eligibility:
All Genders
6-10 years
Phase:
PHASE4
Brief Summary
Influenza, a highly communicable acute respiratory disease, is one of the major infectious disease threats to the human population. In Africa, information on the occurrence of influenza and its diseas...
Detailed Description
The trial will take place in the study area of the Niakhar demographic surveillance system in Senegal, a population representative of rural impoverished Africa. Villages will be randomized to TIV or a...
Eligibility Criteria
Inclusion
- A male or female child at least 6 months of age and no older than 10 years of age (has not yet reached 11 years of age) at the enrollment visit.
- A child whose parent or guardian's primary residence, at the time of study vaccinations, is a village compound selected to receive TIV or IPV.
- Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.
Exclusion
- Hypersensitivity to the active substance or any component in either TIV (which includes egg protein) or IPV. (Please see information on composition of vaccines.)
- Hypersensitivity after previous administration of any influenza or polio vaccine.
- Acute severe febrile illness. (Administration of TIV or IPV should be postponed until after recovery. Minor illnesses, such as mild upper respiratory infection, with or without low grade fever, are not reason for postponing vaccination. Acute severe febrile illness is only a temporary exclusion.)
- Any condition that, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the study objectives.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2013
Estimated Enrollment :
10000 Patients enrolled
Trial Details
Trial ID
NCT00893906
Start Date
May 1 2009
End Date
April 1 2013
Last Update
September 23 2013
Active Locations (1)
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1
Niakhar Demographic Surveillance System
Niakhar, Fatick District, Senegal