Healthy male/female adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Healthy male/female volunteers of not less than 50 years old. (2) Volunteers who gave informed consent to take part in this trial after being provided with an explanation of the protocol detail.
Exclusion criteria
Exclusion criteria: (1) Volunteers with influenza-virus infection within a year before giving informed consent to take part in this trial. (2) Volunteers with influenza vaccination recently at the point of giving informed consent to take part in this trial. (3) Volunteers with previous history of some kind of symptom just like anaphylactic shock, which was caused by influenza vaccination. (4) Volunteers taking steadily in the medicine, which might affect the test results. (5) All through this trial, volunteers who have any difficulty in refraining from taking steadily in the health-specific/functional/health foods, which might affect the test results. (6) Pregnant, possibly pregnant, or lactating women. (7) Volunteers with present/previous medical history of serious diseases in heart, liver, kidney and/or digestive organs. (8) Volunteers with excessive alcohol intake. (9) Volunteers with heavy smoking. (10) Volunteers with extremely irregular life rhythms, midnight work and/or irregular shift one. (11) Volunteers with drug and/or food allergy. (12) Volunteers who are now under the other clinical tests with some kind of medicines/foods, or took part in those tests within four weeks after this trial. (13) Volunteers who donated over 200 mL of their whole blood and/or blood components within a month into this trial. (14) Males who donated over 400 mL of their whole blood within the last three months into this trial. (15) Females who donated over 400 mL of their whole blood within the last four months into this trial. (16) Males who will be collected over 1200 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial. (17) Females who will be collected over 800 mL in total of their blood within the last twelve months, after adding the planned sampling blood amounts in this trial. (18) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variations in influenza-antibody titer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. High sensitive IL-4 2. High sensitive IFN-gamma 3. NK cell activity 4. Secretary IgA in saliva | — |
Countries
Japan
Contacts
CPCC Company Limited Planning & Sales Department