E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Suspected primary antibody deficiency states will be investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The study results will allow an informed assessment of the usefulness of the Typhim Vi vaccine against Salmonella typhoid to assess the lack of antibodies to pure bacterial polysaccharide antigens in patients who are antibody deficient. The current vaccine ( pneumovax, Sanofi Pasteur) is likely to be withdrawn from use in the near future, so it is important that a potential replacement polysaccharide vaccine has been examined should this ocurr. |
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E.2.2 | Secondary objectives of the trial |
The secondary question that will be answered is whether a response to the Typhim Vi vaccine correlates with the response to the currently used vaccine, Pneumovax a pneumococcal polysaccharide vaccination is the currently used polysaccharide vaccine |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: 1 Participant (or legal guardian in the case of paediatrics) is willing and able to give informed consent for participation in the study. 2 Male or Female, aged 6 years of age or greater. 3 Presenting patient with suspected antibody deficiency, including although not exclusive to recurrent bacterial infections of the upper and lower respiratory tracts or recurrent otitis media. Other parameters – evidence for bacterial infection: increased CRP, raised WBC or bacterial confirmation. 4 Inclusion of participants should be decided by an immunologist. 5 Healthy volunteers must be in good health. |
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E.4 | Principal exclusion criteria |
Exclusion criteria: 1. Inability or unwillingness to provide informed consent for the study or blood draws. 2. Known previous vaccination with Prevenar vaccine if performed before tests with Pneumovax were carried out. 3. All exclusion criteria as set out on the use of the vaccine including, but not exclusively: history of severe reaction to a vaccine containing similar components. 4. If the recipient is pregnant determined by asking the patient 5. If the recipient is a nursing mother 6. If the recipient has a severe infection or co-morbidity requiring hospitalisation at the time of immunisation. 7. In the case of Pneumovax investigation any individual must be excluded if the recipient has received IVIG or intramuscular and sub-cutaneous immunoglobulin treatment in the last 12 months. 8. Known prior Typhim Vi immunisation 9. Known immuno-compromised, due to immunosuppressive medication or other well-defined immunodeficiency such as HIV. 10. Chromosomal abnormalities and recognised associated clinical symptoms 11. They have had typhoid previously or are a known chronic carrier. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of the proportion of patients responding to pure polysacharide vaccination either by pneumocovax or by Salmonella typhim Vi where a positive response is defined as 3 fold or greater increase in specific antibody titre. |
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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 | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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 | Information not present in EudraCT |
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
|
Last patient, last study visit |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |