N/A (Healthy adults)
Conditions
Interventions
Oral intake of test food or placebo (112 mL) once a day for 9 weeks
Vaccination with influenza vaccine after 3 weeks of intake
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Healthy adults aged 20-59 years [2] Individuals who are able to be vaccinated on schedule [3] Individuals whose BMI is 17-30 [4] Individuals whose written informed consent has been obtained
Exclusion criteria
Exclusion criteria: [1] Individuals who have gotten an allergic reaction to vaccination [2] Individuals who were vaccinated in either 2011/2012, 2012/2013 or 2013/2014 season [3] Individuals who were infected with influenza in either 2011/2012, 2012/2013 or 2013/2014 season [4] Individuals who were infected with influenza before vaccination [5] Individuals who have allergies to dairy products or lactose intolerance [6] Individuals who have a habit to take test food once a week or more in the past 3 months [7] Individuals who have allergies to foods or medicines [8] Individuals who have medical history of allergic diseases like pollinosis that require medications [9] Individuals who have immunodeficiency disease [10] Individuals who have medical history of malignant tumor [11] Individuals who have diabetes mellitus or dyslipidemia that require medications [12] Individuals who are taking medications for chronic diseases, which affect the result of this study [13] Individuals who have medical history of serious diseases that affect the result of this study [14] Individuals who participated in other clinical trials in the past 1 month or who are going to participate in other trials in this study period [15] Women who are going to be pregnant or breastfeeding in this study period [16] Individuals who are judged not suitable to participate in this trial by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [1]Antibody titers specific to influenza vaccine antigen [2]Seroconversion rate [3]Mean geometric increase [4]Seroprotection | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Research
Outcome results
None listed