Type 1 diabetes mellitus MedDRA version: 14.1 Level: LLT Classification code 10000639 Term: Active immunisation System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Prevenar13 (manufactured by Pfizer)
Product Name: Prevenar 13 (PCV13)
Product Code: EMEA/H/C/001104
Pharmaceutical Form: Suspension for injection
Other descriptive name: PNEUMOCOCCAL POLYS
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of the study is to measure pneumococcal antibody concentrations in children with T1DM (6-17 years of age) at 3 months following a single dose of PCV13. As a key secondary objective we will compare the antibody concentrations in chidlren who have previously had PPS23 versus those who have not. ;Secondary Objective: To compare the pneumococcal antibody concentrations for all vaccine-specific serotypes (VS) at baseline, 3 months and 12 months following immunisation with a single dose of PCV13 in children who have had a prior dose of 23-valent pneumococcal polysaccharide vaccine (PPS23) versus those who have not. To measure pneumococcal antibody concentrations in children with T1DM (6-17 years of age) at baseline and 12 months following a single dose of PCV13. To correlate the increase in VS antibody concentration between baseline and 3 months with a standard measure of diabetic glucose control the HbA1C. To compare blood glucose control in the week preceeding and the week following immunisation with PCV13 ;Primary end point(s): The proportion of children with vaccine pneumococcal serotype-specific (SpVS) antibody concentrations >0.35mcg/ml at 3 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13);Timepoint(s) of evaluation of this end point: This end-point will be evaluated at 3 months (for the primary outcome). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare the pneumococcal serotype-specific GMC for all vaccine-specific serotypes (VS) at baseline, 3 months and 12 months following immunisation with a single dose of PCV13 in children who have had a prior dose of 23-valent pneumococcal polysaccharide vaccine (PPS23) versus those who have not. To compare the proportion of children with pneumococcal serotype-specific antibody concentrations >0.35mcg/ml for all VS in children who have had a prior dose of 23-valent pneumococcal polysaccharide vaccine (PPS23) versus those who have not. To correlate the increase in VS antibody concentration between baseline and 3 months with HbA1C. To compare blood glucose control in the week preceeding and the week following immunisation with PCV13;Timepoint(s) of evaluation of this end point: End-points evaluating pneumococcal antibody concentrations will be evaluated at base-line, 3 month and 12 months. | — |
Countries
United Kingdom
Contacts
Public ContactKelly
University of Oxford
Outcome results
None listed