Clinical trial NCT01939522: Protection Against Pneumococcal Infection in Children With T1DM
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: diabetes
pneumococcal
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pneumococcal serotype-specific (SpVS) antibody concentrations at 3 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13)
timeFrame: 3 months after vaccination
Secondary outcomes:
measure: 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.
timeFrame: 3 months after vaccination
measure: Pneumococcal serotype-specific (SpVS) antibody concentrations at baseline and 12 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13).
timeFrame: 12 months after vaccination
measure: GMC of SpVS antibody at baseline, 3mnth and 12mnth following 1 dose of PCV13
timeFrame: 12 months after vaccination
measure: 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.
timeFrame: 12 months after vaccination
measure: 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.
timeFrame: 12 months after vaccination
measure: Vaccine-specific serotype antibody concentration between baseline and 3 months with HbA1C.
timeFrame: 3 months after vaccination
measure: Blood glucose control in the week preceding and the week following immunisation with PCV13
timeFrame: One week after vaccination
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
state: Oxfordshire
Study officials:
References: