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

NCT02819115 | Completed

• 1 other identifier: FLU-01-IB
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Influenza

Keywords

Influenza

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Healthy adults group

Healthy adults aged 18 to 59 years

Biological: Butantan Fragmented Inactivated Trivalent Influenza Vaccine

Elderly group

Elderly over 60 years old.

Biological: Butantan Fragmented Inactivated Trivalent Influenza Vaccine

Interventions

Butantan Fragmented Inactivated Trivalent Influenza Vaccine BIOLOGICAL

Butantan Fragmented Inactivated Trivalent Influenza Vaccine

Also known as: Butantan Influenza Vaccine

Elderly group; Healthy adults group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Butantan Institute: lead

Study Sites (2)

Centro de Pesquisas Clínicas do Instituto da Criança do Hospital das Clínicas

São Paulo, São Paulo, Brazil

Location

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

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 30066805 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2016
• First Posted: June 30, 2016
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 30, 2016

Record last verified: 2016-06

Locations

BR (2)