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Study to Evaluate Safety and Immunogenicity of Butantan Seasonal Influenza Vaccine - FLU-02-IB

NCT ID: NCT02819180

Last Updated: 2016-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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..

Conditions

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Influenza

Keywords

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Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy adults group

Healthy men and women between 18 and 59 years of age.

Butantan Influenza Trivalent, Fragmented and Inactivated vaccine

Intervention Type BIOLOGICAL

Elderly group

Elderly over 60 years old.

Butantan Influenza Trivalent, Fragmented and Inactivated vaccine

Intervention Type BIOLOGICAL

Interventions

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Butantan Influenza Trivalent, Fragmented and Inactivated vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Butantan Influenza vaccine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Butantan Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centro de Referência de Imunobiológicos Especiais (CRIE) Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 30066805 (View on PubMed)

Other Identifiers

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FLU-02-IB

Identifier Type: -

Identifier Source: org_study_id