Immunogenicity of conjugate pneumococcal vaccine (Prevenar) in patients with ataxia -telangiectasia (AT) including a randomised study of one versus two doses of vaccine. - Immunogenicity of Prevenar in Ataxia telangiectasia
Phase 1
- Conditions
- 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.
- Registration Number
- EUCTR2005-004122-70-GB
- Lead Sponsor
- Great Ormond Street Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
1.Patients <2 years old
2.Consent/ assent not given
3.Patient receiving immunoglobulin therapy (around 12% of patients)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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.<br><br><br> ;<br> Secondary Objective: 1. to determine whether two doses of vaccine are more immunogenic than one<br> 2. to determine whether patients with AT can develop immunological memory.<br> ;Primary end point(s): Immunogenicity of the vaccine
- Secondary Outcome Measures
Name Time Method