E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
immunodeficiency |
immuundeficientie |
|
E.1.1.1 | Medical condition in easily understood language |
immune deficiency |
afweerstoornis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
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 develop new criteria for the interpretation of the IgG response to pneumococcal polysaccharide vaccination using serotype-specific normal values. |
|
E.2.2 | Secondary objectives of the trial |
To develop new criteria for the interpretation of the IgG1, IgG2, IgM and IgA response to pneumococcal polysaccharide vaccination using serotype-specific normal values. To study the effect of age and gender on the response to pneumococcal polysaccharide vaccination in healthy adults. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age ≥18 years and ≤80 years • Fits within pre-specified age and gender stratification blocks |
|
E.4 | Principal exclusion criteria |
• Previous vaccination with pneumococcal polysaccharide or conjugate vaccination • Chronic disease that requires the use of immunosuppressive agents • Known or highly suspected primary or secondary immunodeficiency • Pregnancy • Fever or active infection • History of allergic reaction to one of the vaccine components • No informed consent |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Distribution of serotype-specific IgG antibody titers to 13 pneumococcal serotypes. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Four weeks after vaccination. |
|
E.5.2 | Secondary end point(s) |
Distribution of serotype-specific IgG antibody titers to 13 pneumococcal serotypes eight weeks after vaccination. Distribution of serotype-specific IgG1, IgG2, IgM and IgA antibody titers to 13 pneumococcal serotypes four and eight weeks after vaccination. Distribution of serotype-specific percent change in IgG, IgG1, IgG2, IgM and IgA antibody titers to 13 pneumococcal serotypes four and eight weeks after vaccination in comparison to pre-vaccination. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Four and eight weeks after vaccination. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
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 | No |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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
|
The end of the trial is defined as the last study visit for the last patient to be included. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |