Assessment of Salmonella Typhim Vi(TM) vaccine (Sanofi Pasteur MSD) for the investigation of selective antibody deficiency to polysaccharide. - Assessment of Salmonella Typhim Vi Vaccine

Oxford Radcliffe Hospital NHS Trust0 个研究点开始时间: 2010年11月22日最近更新: 2012年3月19日

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•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.
•Are the trial subjects under 18? yes
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•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.

发起方

Oxford Radcliffe Hospital NHS Trust