Enhancement of influenza vaccination effect J10
Conditions
Interventions
Group 1: Active comparator: fermented dairy drink. Subjects consume fermented dairy drink Yakult containing Lactobacillus casei Shirota daily for 7 weeks (1.3x10^10 CFU per day). 4 weeks after start o
Sponsors
Yakult Honsha Co., Ltd.
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Free-living adults aged = 50 years willing to have influenza vaccination season 2011/2012 ? willingness to abstain from food and supplements containing probiotics, prebiotics and other fermented products ? written informed consent
Exclusion criteria
Exclusion criteria: ? Subjects enrolled in another clinical study in the last 4 weeks ? Subjects already vaccinated against influenza during 2011-2012 with either the influenza vaccine used in the present study or another influenza vaccine. ? Subjects previously vaccinated against influenza during 2010-2011 ? Subjects previously vaccinated against pandemic influenza in 2009 or 2010 with an influenza pandemic vaccine (A/H1N1) ? known congenital, acquired or iatrogenic immunodeficiency (e.g. HIV, chemotherapy, immunosuppression) ? active autoimmune diseases ? allergy or hypersensitivity to any component of the vaccine (e. g. chicken egg protein, certain antibiotics) ? allergy or hypersensitivity to any component of the test product (e.g. milk protein) ? suffering from influenza or influenza-like illness in the current winter season (since Nov. 2011) ? symptoms of common infectious diseases (CID) of the airways or other organ systems e.g. gastrointestinal tract in the last 4 weeks before inclusion. ? severe chronic disease (cancer, IBD, malabsorption, malnutrition, chronic inflammatory diseases, renal, hepatic or cardiac diseases, respiratory insufficiency) ? chronic abdominal pain ? systemic treatment or topical treatment likely to interfere with evaluation of the study parameters: antibiotics, intestinal or respiratory antiseptics, antirheumatics, antiphlogistics (except aspirin or equivalent products preventing from aggregation of platelets or blood clotting) and steroids prescribed in chronic inflammatory diseases ? other treatments likely to interfere with study outcome (e.g. laxatives, body weight management and/or medication) ? lactose intolerance ? diabetes mellitus on drug therapy ? severe neurological, cognitive or psychiatric diseases ? surgery or intervention requiring general anaesthesia within 2 months before the study ? pregnancy or lactation ? eating disorders or special diets (e.g. vegan) ? alcohol and products abuse ? legal incapacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titre (GMT) of antibodies against one of the 3 influenza strains in HI test 3 weeks after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Geometric mean fold increase (GMFI = geometric mean of titre folds increases) between baseline (before start of consumption) and 3 weeks after vaccination; 2.Seroprotection rate (defined as percentage of subjects attaining an antibody titre = 40 in HI test); 3.Seroconversion rate (defined as percentage of subjects with at least 4-fold increase in antibody titres in HI test). | — |
Countries
Germany
Contacts
Public ContactJia Zhao
Yakult Europe B.V.
Outcome results
None listed