Ataxia Telangiectasia (AT) is a genetic condition in which there is a deficiency of the immune system with excessive susceptibility to pneumonia and other infections.
Conditions
Interventions
Trade Name: Prevenar
Pharmaceutical Form: Solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of administration of t
Sponsors
Great Ormond Street Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Genetically confirmed diagnosis of AT 2. Patient/Parental informed consent obtained (and assent from appropriately aged children) 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients <2 years old 2. Consent/ assent not given 3. Patient receiving immunoglobulin therapy (around 12% of patients)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to look at the immunogenicity of Prevenar in children with AT associated immunodeficiency in the UK. ; Secondary Objective: 1. to determine whether two doses of vaccine are more immunogenic than one 2. to determine whether patients with AT can develop immunological memory. ;Primary end point(s): Immunogenicity of the vaccine | — |
Countries
United Kingdom
Outcome results
None listed