Influenza Respiratory
Conditions
Interventions
The safety and non-inferiority (rGMT) in terms of immunogenicity (HI antibodies titers and seroconversion, assessed for every vaccine strain) of VII3a-IB compared to VII-HD, 21 days after vaccination,
Sponsors
Instituto Butantan
Eligibility
Sex/Gender
All
Age
60 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult aged 60 years or older at the time of signing the informed consent form 2. Able to understand the study aims, based on the Investigator's assessment, and agrees to follow all study procedures 3. Provision of free and informed written consent
Exclusion criteria
Exclusion criteria: 1. Participation in another clinical trial within 28 days prior to screening or having planned participation in another clinical trial during the study period. 2. Pre-existing health condition that is unstable, at the discretion of the study physician. 3. Pre-existing health condition that led to hospitalization within 90 days prior to study screening. 4. Dementia or any other cognitive condition at a stage that may interfere with adherence to the study protocol, at the discretion of the study physician. 5. Influenza vaccine: having been vaccinated with any influenza vaccine within 180 days prior to screening or having planned vaccination with another influenza vaccine, other than the study vaccine, during participation in the study. 6. Other vaccines (except influenza): having been vaccinated within 14 days prior to screening with any inactivated vaccine, or within 28 days prior to screening with any live attenuated vaccine, or having planned vaccination with any vaccine up to 21 days after the study vaccination. 7. Known hypersensitivity to egg proteins or any of the constituents of the study vaccines. 8. History of Guillain-Barré Syndrome or other demyelinating disease such as encephalomyelitis and transverse myelitis. 9. Thrombocytopenia or bleeding disorder that contraindicates intramuscular vaccination or phlebotomy for sample collection. 10. Continuous use, or use within seven days prior to screening, of anticoagulant medication (such as factor Xa inhibitors, direct thrombin inhibitors, warfarin, low molecular weight heparin, or fondaparinux) at a full anticoagulant dose. 11. Having received immunoglobulins, blood, or blood products within the last 180 days prior to screening. 12. Altered immunocompetence (immunosuppression, immunodeficiency, or immunocompromise) primary or secondary due to: 12.1. Health condition (including, but not limited to, solid organ transplant, HIV, renal failure on hemodialysis, hepatic insufficiency with cirrhosis, heart failure grade III or IV according to the New York Heart Association classification29 and asplenia). 12.2. Active infectious disease or under treatment at screening (including, but not limited to, tuberculosis, pneumonia, osteomyelitis and endocarditis). Individuals with chronic hepatitis B or C, whether or not under treatment, may be included in the study. 12.3. Use of systemic corticosteroids (oral, intravenous or intramuscular) at a dose equivalent to =20 mg/day of prednisone for more than 14 days or a cumulative dose greater than 280 mg, in the last 90 days prior to screening. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in the last 30 days prior to screening) of intra-articular corticosteroids is also permitted. 12.4. Having received an antineoplastic, immunosuppressant, immunomodulatory agent or radiotherapy in the last 180 days prior to screening. 13. Malignant neoplasm at the time of screening or a history of malignant neoplasm with less than five years of disease-free survival at the time of screening (with the exception of basal cell carcinoma of the skin, localized papillary thyroid cancer and localized prostate cancer under active surveillance). 14. Abuse of alcohol and/or illicit drugs in the last 12 months before screening that may compromise compliance with study procedures, at the discretion of the study physician. 15. Inability to obtain a blood sample for immunogenicity assessment at the Day 1 visit. 16. Being part of the stu
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Ratio of the geometric mean titers of HI antibodies induced by VII3a-IB compared to VII-HD, for A/H1N1, A/H3N2 and B/Victoria lineage strains, 21 days after vaccination. 2. Difference in seroconversion rates between VII3a-IB and VII-HD, measured through HI antibody titers, for A/H1N1, A/H3N2 and B/Victoria lineage strains, 21 days after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ratio of the geometric mean titers of HI antibodies induced by VII3a-IB compared to VII-HD, for A/H1N1, A/H3N2, and B/Victoria lineage strains, 21 days after vaccination. 2. Difference in seroconversion rates between VII3a-IB and VII-HD, measured through HI antibody titers, for A/H1N1, A/H3N2, and B/Victoria lineage strains, 21 days after vaccination. 3. Ratio of the geometric mean titers of HI antibodies induced by the VII3a-IB batches (batch1/batch2, batch1/batch3, and batch2/batch3) for A/H1N1, A/H3N2, and B/Victoria lineage strains, 21 days after vaccination. 4. Frequency (n, %) of participants with solicited (local and systemic) and unsolicited adverse reactions occurring up to seven days after vaccination, for VII3a-IB and VII-HD. 5. Frequency (n) and intensity of solicited (local and systemic) and unsolicited adverse reactions occurring up to seven days after vaccination, for VII3a-IB and VII-HD. 6. Description of solicited adverse reactions occurring up to seven days after vaccination according to: medication use (%), duration and time to onset, for VII3a-IB and VII-HD. 7. Frequency (n, %) of participants with adverse events occurring throughout the entire study period, for VII3a-IB and VII-HD. 8. Frequency (n), intensity, causal relationship with the vaccine, and predictability of AEs occurring throughout the study participation period, by grade, for VII3a-IB and VII-HD. 9. Frequency (n, %) of participants with AEs occurring throughout the study participation period, for VII3a-IB and VII-HD. 10. Frequency (n), intensity, and causal relationship with the vaccine of AEs occurring throughout the study participation period, by grade, for VII3a-IB and VII-HD. 11. Description of solicited and unsolicited AEs occurring up to 21 days after vaccination according to: medication use (%) and duration and time to onset of the event, for VII3a-IB and VII-HD. 12. Description of unsolicited AEs occurring up to 21 days after vaccination according to: medication use (%) a | — |
Countries
Brazil
Contacts
Public ContactJoão Miraglia
Outcome results
None listed