Prevention of influenza
Conditions
Interventions
investigational material(s)
Generic name etc : KD-404
INN of investigational material : -
Therapeutic category code : 631 Vaccines
Dosage and Administration for Investigational material : [part 1] -Su
Sponsors
KM Biologics Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: -Healthy adult males aged >= 20 years to < 65 years at the time of the first administration of the study drug -Those who judged to be healthy adults qualified to participate in this clinical trial by the principal investigator or subinvestigator as a result of the screening exam -Those who have given written informed consent
Exclusion criteria
Exclusion criteria: -Those who had influenza (between the 2017/18 season (9. 2017-8. 2018) and the first administration of the study drug based on hearing from subjects) -Those who had a previous vaccination with influenza HA vaccine within 6 months prior to the first administration of the study drug (based on hearing from subjects) -Those who have clearly presented anaphylaxis caused by the following components in the past Gentamicin sulfate, streptomycin sulfate, thimerosal -Those who have a previous history of the following diseases: Guillain-Barre syndrome, acute disseminated encephalomyelitis, thrombocytopenic purpura, decreased platelet count, vasculitis, encephalitis/encephalopathy, myelitis, mucocutaneous ocular syndrome, nephrotic syndrome -Those who underlying disease(s) such as cardiovascular disease, renal disease, hepatic disease, hematological disease, or developmental disorders, etc. -Those who developed fever or presented allergy-suspected symptoms, such as generalized rash, within 2 days after any previous vaccination -Those who have previous history of convulsion -Those who had diagnosed with immunodeficiency in the past or have a close relative with congenital immunodeficiency syndrome -Those who have respiratory disease(s) such as interstitial pneumonia and bronchial asthma -Those who could be allergic to the components of the study drugs or to chicken eggs, chicken meat, or other chicken derivatives -Those who have participated in another clinical study and received administration of another study drug within 4 months (120 days) prior to the first administration of the study drug -Those who have received blood transfusion or administration of gamma globulin preparation within 3 months (90 days) prior to the first administration of the study drug or have received high-dose gamma globulin therapy (>= 200 mg/kg) within 6 months (180 days) prior to the first administration of the study drug -Those who have received any therapy that affects immune function, such as radiotherapy, immunosuppressants (except for topical products), immunosuppressive therapy, anti-rheumatic drugs, adrenocorticotropic hormone drugs, and corticosteroids (when the treatment period is 14 days or more for prednisolone equivalent or total daily dose >= 20 mg. However, topical preparations are permitted) within 6 months (180 days) prior to the first administration of the study drug -Those who had determined not suitable as study participants by the principle investigator or sub-investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety efficacy -Seroconversion rate, GMT conversion rate, seroprotection rate, and GMT for HI antibodies against each vaccine strain after the first administration (Day 21) and second administration (Day 42) -Adverse event ratio -Adverse reaction ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy -Seroconversion rate, GMT conversion rate, seroprotection rate, and GMT for SRH antibodies against each vaccine strain after the first administration (Day 21) and second administration (Day 42) -Rate of greater than four-fold increase, GMT conversion rate, and GMT for neutralizing antibody titer against each vaccine strain after the first administration (Day 21) and second administration (Day 42) -Rate of greater than four-fold increase, GMT conversion rate, and GMT for neutralizing antibody titer against influenza virus strains other than vaccine strain after the first administration (Day 21) and second administration (Day 42) -Seroconversion rate, GMT conversion rate, seroprotection rate, and GMT for HI antibodies against each vaccine strain after the first administration (Day 3, 7) and second administration (Day 24, 28) | — |
Countries
Japan
Outcome results
None listed