Clinical trial NCT02819180: Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine - FLU-02-IB
Official title: Prospective Cohort Study to Evaluate Safety and Immunogenicity of Butantan Seasonal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Influenza
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
First posted: 2016-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: Prospective cohort study to evaluate the safety and immunogenicity of the Butantan Influenza vaccine (Fragmented and Inactivated) among healthy adults with 18 to 59 years of age and elderly older than 60 years of age.

Detailed description: Prospective cohort study to assess safety of one dose of theButantan Influenza vaccine (Fragmented and Inactivated) in the first 3 days after vaccination and its immunogenicity 21 days after vaccination among healthy adults with 18 to 59 years of age and elderly older than 60 years of age..

Eligibility 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

Primary outcomes:
measure: Adverse events in the first 3 days post vaccination (Safety)
timeFrame: Three days
measure: Antibody response to each of the vaccine strains 21 days post vaccination (Immunogenicity)
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
state: SP
Study officials:
References:
citation: 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.