- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02819115
Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine (FLU-01-IB)
June 29, 2016 updated by: Butantan Institute
Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine
Prospective study to evaluate the safety and immunogenicity of Butantan Influenza seasonal vaccine.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
63
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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SP
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Sao Paulo, SP, Brazil
- Centro de Pesquisas Clínicas do Instituto da Criança do Hospital das Clínicas
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Sao Paulo, SP, Brazil
- Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Health adults with age between 18 and 59 years, as well as elderly over 60 years of age may participate in the study.
To be included in the study, participants need to meet all inclusion criteria, and not fulfill any exclusion criteria.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Elderly group
Elderly over 60 years old.
|
Butantan Fragmented Inactivated Trivalent Influenza Vaccine
Other Names:
|
Healthy adults group
Healthy adults aged 18 to 59 years
|
Butantan Fragmented Inactivated Trivalent Influenza Vaccine
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety assessed by unsolicited local and systemic adverse reactions
Time Frame: 3 days
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Vaccine safety assessed by unsolicited local and systemic adverse reactions up to 3 days post vaccination
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3 days
|
Antibody response to each of the vaccine´s strains (Immunogenicity)
Time Frame: 21 days
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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.
|
21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
June 28, 2016
First Submitted That Met QC Criteria
June 29, 2016
First Posted (Estimate)
June 30, 2016
Study Record Updates
Last Update Posted (Estimate)
June 30, 2016
Last Update Submitted That Met QC Criteria
June 29, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FLU-01-IB
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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