Prospective study to evaluate the safety and immunogenicity of Butantan Influenza seasonal vaccine.
Full Title of Study: “Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: July 2013
Prospective cohort study to evaluate safety (three days post vaccination) and immunogenicity (measured 21 days post vaccination) of one dose of Butantan Influenza vaccine.
- Biological: Butantan Fragmented Inactivated Trivalent Influenza Vaccine
- Butantan Fragmented Inactivated Trivalent Influenza Vaccine
Arms, Groups and Cohorts
- Healthy adults group
- Healthy adults aged 18 to 59 years
- Elderly group
- Elderly over 60 years old.
Clinical Trial Outcome Measures
- Safety assessed by unsolicited local and systemic adverse reactions
- Time Frame: 3 days
- Vaccine safety assessed by unsolicited local and systemic adverse reactions up to 3 days post vaccination
- Antibody response to each of the vaccine´s strains (Immunogenicity)
- Time Frame: 21 days
- Antibody response to each of the vaccine´s strains as measured by % seroconversion, and/or increase in the geometric mean of hemagglutination inhibition (HAI) titers and/or % seroprotection.
Participating in This Clinical Trial
- Healthy adults, male or female aged 18 to 59 – Elderly aged 60 years completed and above – To be available to participate in the study throughout its duration (approximately 21 days) – To have medical indication to be vaccinated against influenza – To demonstrate intention to participate in the study, as documented by signature in the study´s informed consent form. Exclusion Criteria:
- Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as clinical history and/or physical examination (except hypertension under control among the elderly) – Compromised immune system diseases including: HIV, diabetes mellitus, cancer (except basal cell carcinoma) and autoimmune diseases – Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements – Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history – Known systemic hypersensitivity to eggs or to any component of the vaccine – History of severe adverse reaction after previous administration of an Influenza vaccine within 6 weeks following vaccination – History of Guillain-Barre Syndrome or other demyelinating disease – Diagnosis of asthma with a history of hospitalization in the last six months due to illness – Suspected or confirmed fever in the 3 days prior to vaccination or axillary temperature greater than 37.8 ° C on the day of vaccination – Use of corticosteroids (except topical or nasal) or other immunosuppressive drugs within 42 days before study initiation/baseline. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose ≥10 mg of prednisone per day for over 14 days – Impaired coagulation due to chronic disease or due to use anticoagulant medication (warfarin or heparin) in the 7 days preceding vaccination – Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 21 days after vaccination – Have received influenza vaccine in the past 6 months; – History of asplenia – Have received blood products in the past 6 months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the first 21 days after vaccination – have a counter indication for Influenza vaccination, including allergy to egg proteins – Use of any investigational product within 42 days before vaccination; – Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator's opinion or his representative physician.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Butantan Institute
- Provider of Information About this Clinical Study
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