Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine

Influenza Clinical Trial

— FLU-01-IB  

Official title:

Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02819115
• Other study ID #: FLU-01-IB
• Status: Completed
• Phase: Phase 4
• First received: June 28, 2016
• Last updated: June 29, 2016
• Start date: June 2013
• Est. completion date: July 2013

Study information

• Verified date: June 2016
• Source: Butantan Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Butantan Fragmented Inactivated Trivalent Influenza Vaccine
Butantan Fragmented Inactivated Trivalent Influenza Vaccine

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Butantan Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by unsolicited local and systemic adverse reactions	Vaccine safety assessed by unsolicited local and systemic adverse reactions up to 3 days post vaccination	3 days	Yes
Primary	Antibody response to each of the vaccine´s strains (Immunogenicity)	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	No