Basic healthy volunteers
Conditions
Interventions
Trade Name: Pandemrix
Product Name: Pandemrix
Pharmaceutical Form: Solution for injection
Other descriptive name: PANDEMIC INFLUENZA VACCINE (H5N1) (SPLIT VIRION, INACTIVATED, ADJUVANTED)
Trade Name:
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged =18 to =65 years 2. General good health as established by medical history and physical examination 3. Written informed consent 4. Available for all visits scheduled in this study. 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 380 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Vaccination against same pathogen in resently 2. Resent history of disease that is causing by pathogen which against the vaccine is indicated. 3. Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 4. Current intake of antibiotics or end of antibiotic therapy <8 days before first IMP administration of oral vaiinse 5. 6 months before the first dose of IMP; oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed 6. Acute or chronic clinically significant gastrointestinal disease 7. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection 8. Pregnancy or lactation 9. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of =38 °C). 10. Alcohol or drug abuse 11. Suspected non-compliance 12. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the homing potentials of circulating vaccine antigen-specific antibodysecreting cells towards gut mucosa (Dukoral, Vivotif), systemic immune system (Typherix, Prevenar, Prevenear13, Pneumovax, Flupar, Pandemrix, Vacxigrip) and cutaneous sites (Intanza) after immunisation with diffferent vaccines.;Secondary Objective: To evaluate the immunogenicity of the different vaccines against the same pathogen (Vivotif in comparison to Typherix®, Intanza® in comparison to Vacxigrip® and Flupar® in comparison to Pandemrix®, Pneumovax® in comparison to Prevenar13® or Prevenar®).;Primary end point(s): Measurement of specific IgA -, IgG- and IgM-secreting antibody cells specific to pathogen or antigen specific for the investigated vaccine in peripheral blood using ELISPOT.;Timepoint(s) of evaluation of this end point: The sample will be taken on day 7 after vaccination. | — |
Countries
Finland
Outcome results
None listed