18 years old or older volunteers with general good health
Conditions
Interventions
Trade Name: Prevenar13
Product Name: Prevenar13
Pharmaceutical Form: Solution for injection
Other descriptive name: PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE (ADSORBED)
Trade Name: Havrix
Product
Sponsors
Helsinki University Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged =18 2. General good health as established by medical history and physical examination 3. Written informed consent 4. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. 5. Available for all visits scheduled in this study. 6. No previous Pnc vaccination 7. No previous hepatitis A vaccination or incomplete series (one dose) of hepatitis A vaccination 8. No other vaccines administered 30 days prior to or during the 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 550 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. Previous pneumococcal vaccination 2. Two or more previous doses of hepatitis A vaccine 3. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study 4. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of IMP; patients using oral corticosteroids in dosages of =0.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed 5. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection 6. Pregnancy or lactation 7. 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). 8. Alcohol or drug abuse 9. Suspected non-compliance 10. Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period 11. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator 12. Employee at the investigational site, relative or spouse of the investigator 13. Any other criteria which, in the investigator’s opinion, would compromise the ability of the subject to participate in the study, the subject’s well-being, or the outcome of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study whether a simultaneously given hepatitis A vaccine will have an impact on the immune response to PCV13 (Prevenar13) vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. The results of volunteers receiving PCV13 and hepatitis A will be compared to that in a control group of adults receiving PCV13 vaccine only.;Secondary Objective: To study whether a simultaneously given PCV13 vaccine will have an impact on the immune response to hepatitis A (Epaxal or Havrix) vaccine in adults. The immune response to hepatitis A vaccine is measured as levels of serum antibodies (ELISA). The results of volunteers receiving PCV13 and hepatitis A will be compared to that in a control group of adults receiving hepatitis A vaccine only.;Primary end point(s): Measurement of serum IgG-antibodies specific to all 13 pneumococcal polysaccharides evaluated as antibody levels (enzyme immunoassay) and opsonophagocytic activity (OPA) ;Timepoint(s) of evaluation of this end point: One month after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the levels of antibodies specific to hepatitis A vaccine administered simultaneously (=10IU/mL) ;Timepoint(s) of evaluation of this end point: One month after vaccination | — |
Countries
Finland, Sweden
Outcome results
None listed