Protection against Pneumococcal infection in children with T1DM
Phase 4
Completed
- Conditions
- Topic: Medicines for Children Research NetworkSubtopic: All DiagnosesDisease: All DiseasesNutritional, Metabolic, EndocrineInsulin-dependent diabetes mellitus
- Registration Number
- ISRCTN40519356
- Lead Sponsor
- niversity of Oxford (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
1. Diagnosis of T1DM and being followed in the Oxfordshire Children?s Diabetes Service
2. Aged from 6-17 years old
3. Parent/legal guardian willing and able to give informed consent
4. No previous immunisation with a pneumococcal conjugate vaccine (PCV)
5. Willing to allow the General Practitioner to be notified of participation in the study
Exclusion Criteria
1. Known allergic reaction to the vaccine antigen or any of the excipients
2. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of children with vaccine pneumococcal serotype specific (SpVS) antibody concentration. The immune response will be assessed at baseline, 3 months and 12 months after immunisation.
- Secondary Outcome Measures
Name Time Method ot provided at time of registration