E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Immune response to pneumococcal vaccination in patients after community acquired pneumonia with Streptococcus pneumoniae |
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E.1.1.1 | Medical condition in easily understood language |
Immune respons to vaccination in patients after pneumonia |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071915 |
E.1.2 | Term | Vaccination site bleeding |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046860 |
E.1.2 | Term | Vaccination adverse reaction |
E.1.2 | System Organ Class | 100000004863 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069488 |
E.1.2 | Term | Vaccination site paresthesia |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069630 |
E.1.2 | Term | Vaccination site edema |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059078 |
E.1.2 | Term | Vaccination related malaise |
E.1.2 | System Organ Class | 100000004863 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046859 |
E.1.2 | Term | Vaccination |
E.1.2 | System Organ Class | 100000004865 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069485 |
E.1.2 | Term | Vaccination site stinging |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069631 |
E.1.2 | Term | Vaccination site tenderness |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069473 |
E.1.2 | Term | Vaccination site hematoma |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069486 |
E.1.2 | Term | Vaccination site discoloration |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069487 |
E.1.2 | Term | Vaccination site hemorrhage |
E.1.2 | System Organ Class | 100000004867 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10067538 |
E.1.2 | Term | Inappropriate route of vaccination |
E.1.2 | System Organ Class | 100000004863 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10069483 |
E.1.2 | Term | Vaccination site burning |
E.1.2 | System Organ Class | 100000004867 |
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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 investigate antibody response after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia in the past |
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E.2.2 | Secondary objectives of the trial |
To investigate antibody response after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia in the past who failed to elicit a specific antibody response previously.
To investigate the cellular immune responses after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia in the past.
To investigate quality of life by the RAND-36 score in patients with a community acquired pneumonia in the past.
To investigate the long-term mortality after community acquired pneumococcal pneumonia.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients who participated in the Ovidius or Triple-P study (2004-2009).
2. Diagnosis in these studies with pneumococcal pneumonia or pneumonia due other identified organism.
3. Age ≥ 18 years.
4. Signing of informed consent.
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E.4 | Principal exclusion criteria |
1. Diagnosis of pneumonia without an identified causative organism.
2. Fever at time of vaccination.
3. Previous/known allergic reaction to any of the components of the vaccine given.
4. Mentally incompetent.
5. Previous pneumococcal vaccination*
* with exception of patients displaying a persistent defect in the serotype specific immune response after vaccination with the polysaccharide-based vaccine Pneumovax 23. Possibly this specific serotype defect will be ‘’repaired’’ after vaccination with the (more potent) conjugate vaccine Prevnar 13. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Antibody response after pneumococcal vaccination in patients with community acquired pneumococcal pneumonia in the past.
Parameters are:
• Antibody titers against 13 different serotypes of S. pneumoniae before and after vaccination. Patients will be classified in overall / serotype specific response.
• Avidity maturation against 13 different serotypes of S. pneumoniae will be calculated with relative avidity index (RAI).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
3-4 weeks after vaccination |
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E.5.2 | Secondary end point(s) |
• Antibody response after pneumococcal vaccination in subset of patients with community acquired pneumococcal pneumonia in the past who failed to elicit a specific antibody response previously.
• Immunoglobulin levels and subclasses.
• Lymphocyte subsets (number of B cells, CD3, CD4, CD8 and NK cells).
• Cellular immune responses.
• Quality of life (RAND-36).
• Long-term mortality after community acquired pneumococcal pneumonia.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
3-4 weeks 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 | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
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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
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The study will end with the last visit of the last patient |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |