Protection Against Pneumococcal Infection in Children With T1DM
T1DM
An Open Label Single-arm Trial of the Immunogenicity and Reactogenicity of a 13-valent Pneumococcal Conjugate Vaccine (Prevenar13®) Given to Children With Type 1 Diabetes Mellitus Who Have Not Previously Received a Primary Schedule of Immunisation With Pneumococcal Conjugate Vaccines in Infancy.
2 other identifiers
interventional
50
1 country
1
Brief Summary
Children/ young people with diabetes may be at a higher risk of acquiring certain infections. These infections include those caused by a bacterium called the pneumococcus which can cause pneumonia, meningitis and ear infections. In the UK older children with diabetes are given a vaccine against the pneumococcus bug called Pneumovax (or PPS23 for short). Although PPS23 causes a good immune response in children over 2 years of age it is not actually known how well PPS23 protects against infection in children of any age. In addition there is some data in adults and children that PPS23 may result in a reduced response to future doses of pneumococcal vaccines (hyporesponsiveness). Because of the lack of information on how well PPS23 protects and potential hyporesponsiveness the investigators would like to study the use of an alternative vaccine against pneumococcus called Prevenar13 (or pCV13). This vaccine is known to be safe and to work well in babies and young children and there have been no concerns about hyporesponsiveness. It has been approved for use in children up to 17 years of age but there is little information on the size and duration of immune response to PCV13 in children aged 6 years and older.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2013
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedMay 9, 2017
May 1, 2017
2.7 years
June 4, 2013
May 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pneumococcal serotype-specific (SpVS) antibody concentrations at 3 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13)
The geometric mean concentration (GMC), together with 95% confidence intervals, of SpVS antibody at baseline, 3 months and 12 months following a single dose of PCV13.
3 months after vaccination
Secondary Outcomes (7)
Pneumococcal serotype-specific GMC for serotypes 4, 7F & 19A at 3 months after immunisation with a single dose of PCV13 in the children who have had a prior dose of PPS23 vs those who have not.
3 months after vaccination
Pneumococcal serotype-specific (SpVS) antibody concentrations at baseline and 12 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13).
12 months after vaccination
GMC of SpVS antibody at baseline, 3mnth and 12mnth following 1 dose of PCV13
12 months after vaccination
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 PPS23 and those who have not.
12 months after vaccination
Pneumococcal serotype-specific antibody concentrations for all VS in children who have had a prior dose of 23-valent pneumococcal polysaccharide vaccine (PPS23) and those who have not.
12 months after vaccination
- +2 more secondary outcomes
Study Arms (1)
Prevenar13® (13-valent pneumococcal conjugate vaccine)
EXPERIMENTALPrevenar13 administered as a single dose, 0.5ml Intramuscular liquid form intervention at baseline.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of T1DM and being followed in the Oxfordshire Children's Diabetes Service.
- Aged between 6 years and 17 years.
- Parent/legal guardian willing and able to give informed consent.
- No previous immunisation with a pneumococcal conjugate vaccine (PCV).
- Willing to allow the General Practitioner to be notified of participation in the study.
You may not qualify if:
- Known allergic reaction to the vaccine antigen or any of the excipients.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 9DU, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2013
First Posted
September 11, 2013
Study Start
August 1, 2013
Primary Completion
April 1, 2016
Study Completion
January 1, 2017
Last Updated
May 9, 2017
Record last verified: 2017-05