A Randomized, Triple-blinded, Placebo-controlled, Parallel Group Study, to Assess the Effect of Multistrain Probiotic on the Immune Response to the Influenza Vaccination

The Archer-Daniels-Midland Company1 site in 1 country120 target enrollmentOctober 27, 2023

ConditionsInfluenza

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Influenza
Sponsor: The Archer-Daniels-Midland Company
Enrollment: 120
Locations: 1
Primary Endpoint: Change in serum strain-specific geometric mean antibody titers (determined by hemagglutination inhibition [HAI] tests)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, triple-blinded, placebo-controlled, parallel group study, to assess the effect of multistrain probiotic on the immune response to the Influenza vaccination

Registry

clinicaltrials.gov

Start Date

October 27, 2023

End Date

January 12, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The Archer-Daniels-Midland Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female adults aged 18-65 years
•According to the clinical judgment of the physician, appropriate to be vaccinated against the influenza virus.
•Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AE/SAE.
•Have been informed and have given written consent for the use of their data in accordance with local regulations before study inclusion.
•If sexually active, commitment to use contraception methods.
•Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1

Exclusion Criteria

•Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.
•Asymptomatic chronic conditions or findings (e.g., mild hypertension, dyslipidemia) that are not associated with evidence of end-organ damage are not exclusionary provided that they are being appropriately managed and are clinically stable (i.e., unlikely to result in symptomatic illness within the time-course of this trial) in the opinion of the investigator.
•Acute or chronic illnesses or conditions which may be reasonably predicted to become symptomatic if treatment were withdrawn or interrupted are exclusionary, even if stable.
•Acute or chronic illnesses reasonably expected to be associated with increased risks in the event of influenza infection (e.g., cardio-pulmonary diseases, diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are exclusionary, even if stable.
•Participation in research involving a drug, biologic or device within 45 days before planned date of V
•History of a serious reaction to a prior influenza vaccination (any influenza vaccine, not exclusive to INFLUVAC TETRA).
•Hypersensitivity or allergy to INFLUVAC TETRA, its active substance, or components e.g. eggs (ovalbumin, chicken proteins), formaldehyde, cetyltrimethylammonium bromide, polysorbate 80, gentamicin, potassium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, water for injections.
•Hypersensitivity or allergy to any of the ingredients of the investigational product (IP) or placebo.
•Individuals with thrombocytopenia, any coagulation disorder or who are pharmacologically anticoagulated.
•History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza vaccine.

Outcomes

Primary Outcomes

Change in serum strain-specific geometric mean antibody titers (determined by hemagglutination inhibition [HAI] tests)

Time Frame: V2 (3 weeks), V3 (6 weeks)

Change in serum strain-specific geometric mean antibody titers (determined by hemagglutination inhibition \[HAI\] tests) specific for each of the 3 (out of the 4) virus strains included in the INFLUVAC TETRA vaccine, between intervention and placebo from V2 to V3. Higher values mean better immune response.

Secondary Outcomes

VAPI (Vaccinees' Perception of Injection) Questionnaire(V3 (6 weeks))
Change in GSRS (Gastrointestinal Symptom Rating Scale) questionnaire scoring(V1 (Baseline), V2 (3 weeks), V3 (6 weeks))
Change in seroconversion rate (as measured by HAI tests)(V2 (3 weeks), V3 (6 weeks))
Change in geometric mean neutralizing antibody (nAb) titers (as measured by microneutralization assays)(V2 (3 weeks), V3 (6 weeks))
Change in stool microbiome composition(V1 (Baseline), V3 (6 weeks))
Change in seroprotection rate (as measured by HAI tests)(V2 (3 weeks), V3 (6 weeks))
Change in seroprotection rate (as measured by nAb titers in a microneutralization assay)(V2 (3 weeks), V3 (6 weeks))
Change in seroconversion rate (as measured by nAb titers in a microneutralization assay)(V2 (3 weeks), V3 (6 weeks))
Change in innate immune response(V2 (3 weeks), V3 (6 weeks))
Change in the adaptive immune response(V2 (3 weeks), V3 (6 weeks))
Adverse Events(V3 (6 weeks))