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

• ClinicalTrials.gov Identifier: NCT02819115
• Recruitment Status: Completed
• First Posted: June 30, 2016
• Last Update Posted: June 30, 2016
• Sponsor: Butantan Institute
• Information provided by (Responsible Party): Butantan Institute

Study Description

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.

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mondini G, Braga PE, Lopes MH, Sartori AMC, Miyaji KT, Infante V, Randi BA, Timenetsky MDCST, Ferreira JCOA, Sakita NK, Precioso AR. Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan. Rev Inst Med Trop Sao Paulo. 2018 Jul 30;60:e37. doi: 10.1590/S1678-9946201860037.

• Responsible Party: Butantan Institute
• ClinicalTrials.gov Identifier: NCT02819115
• Other Study ID Numbers: FLU-01-IB
• First Posted: June 30, 2016
• Last Update Posted: June 30, 2016
• Last Verified: June 2016

Keywords provided by Butantan Institute:

Influenza

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Vaccines; Immunologic Factors; Physiological Effects of Drugs