Pneumococcal conjugate vaccine in children with T1DM

Phase 1

• Conditions: Type 1 diabetes mellitus; MedDRA version: 14.1Level: LLTClassification code 10000639Term: Active immunisationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2013-001024-19-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-16
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• 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.

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

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 clinical trial of medicinal product
• Study Design: Not specified