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Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine (FLU-01-IB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02819115
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Information provided by (Responsible Party):
Butantan Institute

Brief Summary:
Prospective study to evaluate the safety and immunogenicity of Butantan Influenza seasonal vaccine.

Condition or disease Intervention/treatment
Influenza Biological: Butantan Fragmented Inactivated Trivalent Influenza 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.

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Study Type : Observational
Actual Enrollment : 63 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine
Study Start Date : June 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Group/Cohort Intervention/treatment
Healthy adults group
Healthy adults aged 18 to 59 years
Biological: Butantan Fragmented Inactivated Trivalent Influenza Vaccine
Butantan Fragmented Inactivated Trivalent Influenza Vaccine
Other Name: Butantan Influenza Vaccine

Elderly group
Elderly over 60 years old.
Biological: Butantan Fragmented Inactivated Trivalent Influenza Vaccine
Butantan Fragmented Inactivated Trivalent Influenza Vaccine
Other Name: Butantan Influenza Vaccine




Primary Outcome Measures :
  1. 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

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02819115


Locations
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Brazil
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
Sponsors and Collaborators
Butantan Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Butantan Institute
ClinicalTrials.gov Identifier: NCT02819115     History of Changes
Other Study ID Numbers: FLU-01-IB
First Posted: June 30, 2016    Key Record Dates
Last Update Posted: June 30, 2016
Last Verified: June 2016
Keywords provided by Butantan Institute:
Influenza
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs