effect of probiotics on the immune response to seasonal influenza vaccination in healthy adults MedDRA version: 14.1 Level: LLT Classification code 10016794 Term: Flu vaccination System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10036897 Term: Prophylactic vaccination System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1 Level: LLT Classification code 10046859 Term: Vaccination System Organ Class: 1
Conditions
Interventions
Trade Name: Influvac 2011/2012
Product Name: Influvac
Pharmaceutical Form: Injection
Trade Name: Lactobacillus paracasei subsp. paracasei, L.casei 431
Pharmaceutical Form:
Route of administration of
Sponsors
Chr. Hansen A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women in a general good state of health 2. Age 18-60 years both inclusive 3. BMI 19-30 kg/m2 4. Provided voluntary written informed consent Subjects are eligible for randomization if they fulfill the following two criteria during the run-in period: 5. Has not taken any antibiotics during the run-in period. 6. Has been able to abstain from fermented dairy products (such as yoghurts) as well as foods and food supplements containing probiotics during the run-in period. Single violations will be allowed. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1058 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Chronic immunological diseases such as known HIV infection, rheumatoid arthritis, multiple sclerosis, diabetes requiring insulin treatment, asthma, allergy, eczema, inflammatory bowel disease, crohn’s disease, thyroid diseases. Subjects with chronic diseases and conditions with no potential impact on the primary endpoint are not excluded provided they have been adequately controlled with concomitant medication for at least three months. Subjects with hay fever may also be enrolled outside the pollen season 2. No cancers within the past five years with the exception of carcinoma in situ and basal-cell carcinoma. 3. Influenza vaccination current season or has already suffered from influenza during the current season 4. Acute disease requiring treatment 5. Use of immunosuppressant medication except locally acting glucocorticoids within one month prior to the screening visit 6. Lactose intolerance or milk protein allergy 7. Hypersensitivity to any of the components of the vaccine 8. Recent (6 months) complicated gastrointestinal (GI) surgery that may have an impact on GI tract function 9. Oral antibiotics within one month prior to the screening visit, or within four months prior to the screening visit if given for a recurrent condition 10. Elite athletes with intensive physical activity more than two hours/day (i.e. 14 hour/week) 11. Participation in another clinical trial within the past month 12. For women: pregnant or lactating, or wish to be pregnant during the study 13. For women: not willing to use reliable contraceptive methods. In Germany the following methods are allowed: hormonal contraceptives (oral or implants), tubal ligation, intrauterine device, condoms or sexual abstinence. In Denmark the following methods are allowed: hormonal contraceptives (oral or implants), tubal ligation, intrauterine device or double barrier. Women must use reliable methods from screening until after the final study visit.. 14. Known allergy or systemic allergy-like hypersensitivity to chicken protein, irrespective of the severity of the previous symptoms or of the contact route to the allergen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of probiotics on the immune response to seasonal influenza vaccination in healthy adults measured as seroprotection and seroconversion rate and increases in geometric mean titers (GMT).;Secondary Objective: To investigate the effect of probiotics on selected parameters of the adaptive immune system in healthy adults after vaccination with seasonal influenza vaccine.;Primary end point(s): Seroprotection rates for the three virus strains in the vaccine . Seroprotection rate is defined as proportion of subjects with an HAI titer = 40.;Timepoint(s) of evaluation of this end point: measured at Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Seroconversion rate for each of the three virus strains in the vaccine. Seroconversion rate is defined as proportion of subjects with a pre-vaccination titer 10 and at least a four fold increase in post-vaccination titer. - Geometric mean titers (GMT) - Influenza specific secretory IgA in saliva ;Timepoint(s) of evaluation of this end point: measured at Day 21 | — |
Countries
Denmark, Germany
Contacts
Public Contactdkcmm@chr-hansen.com
Chr. Hansen A/S
Outcome results
None listed