E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
50 years old or older volunteers with general good health |
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E.1.1.1 | Medical condition in easily understood language |
50 years old or older volunteers with general good healt |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To study whether a simultaneously given PCV13 vaccine will have an impact on the immune response to hepatitis A (Epaxal) 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female subjects aged ≥50 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 other vaccines administered 30 days prior to or during the study
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E.4 | Principal exclusion criteria |
1. Previous pneumococcal vaccination 2. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study 3. 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 4. 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
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E.5 End points |
E.5.1 | 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)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One month after vaccination.
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E.5.2 | Secondary end point(s) |
To evaluate the levels of antibodies specific to hepatitis A vaccine administered simultaneously (≥10IU/mL)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
One month after vaccination |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 300 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |