Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine
Completed
- Conditions
- Influenza
- Registration Number
- NCT02819115
- Lead Sponsor
- Butantan Institute
- Brief Summary
Prospective study to evaluate the safety and immunogenicity of Butantan Influenza seasonal vaccine.
- Detailed Description
Prospective cohort study to evaluate safety (three days post vaccination) and immunogenicity (measured 21 days post vaccination) of one dose of Butantan Influenza vaccine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety assessed by unsolicited local and systemic adverse reactions 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) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Centro de Pesquisas Clínicas do Instituto da Criança do Hospital das Clínicas
🇧🇷Sao Paulo, SP, Brazil
Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
🇧🇷Sao Paulo, SP, Brazil
Centro de Pesquisas Clínicas do Instituto da Criança do Hospital das Clínicas🇧🇷Sao Paulo, SP, Brazil