Status:
COMPLETED
Immunogenicity and Safety Trial of Adjuvanted and Non-adjuvanted Trivalent Influenza Vaccine in Tropical Africa
Lead Sponsor:
PATH
Collaborating Sponsors:
Institut de Recherche pour le Developpement
Centers for Disease Control and Prevention
Conditions:
Influenza
Eligibility:
All Genders
6-71 years
Phase:
PHASE2
Brief Summary
This study will provide the Senegal Ministry of Health with data on the safety and immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose seasonal non-adjuvanted t...
Detailed Description
The is a phase 2b, single-center, randomized, observer-blind, parallel group, placebo-controlled trial of the immunogenicity and safety of adjTIV and seasonal TIV among healthy children aged 6 months ...
Eligibility Criteria
Inclusion
- A male or female child at least 6 months of age and under 6 years of age (has not yet reached 72 months of age) at the enrollment visit.
- Free of obvious health problems, as established by the medical history and screening evaluations, including physical examination.
- Subject's parent or legal guardian is willing to provide written informed consent prior to the subject's first study vaccination.
Exclusion
- Known hypersensitivity to any component in adjTIV or TIV (which include egg protein) or placebo.
- Receipt of any non-study vaccine within two weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 56 visit.
- Previous receipt of any influenza vaccine.
- Hypersensitivity after previous administration of any vaccine.
- Acute illness accompanied by a body temperature of 37.5°C or greater (axillary measurement) within 14 days of enrollment visit. (Enrollment and administration of adjTIV, TIV, or placebo should be postponed until at least 14 days after recovery. Minor illnesses, such as mild upper respiratory infection, with an axillary temperature of \<37.5°C, are not reason for exclusion or postponing study vaccination.)
- Any condition that, in the opinion of the investigator, would pose a health risk to the participant if he/she participates in the study or would interfere with the evaluation of the study objectives.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
296 Patients enrolled
Trial Details
Trial ID
NCT01819155
Start Date
April 1 2013
End Date
September 1 2013
Last Update
October 22 2013
Active Locations (1)
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1
Institut de Recherche pour le Développement
Niakhar, Senegal