Skip to main content
OpenTrials
Completed

NCT Number: NCT01939522

Protection Against Pneumococcal Infection in Children With T1DM

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

13-valent pneumococcal conjugate vaccine (PCV13)

Biological

Other names: Prevenar13®

Primary outcomes

  1. Pneumococcal serotype-specific (SpVS) antibody concentrations at 3 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13)

    Time frame: 3 months after vaccination

    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.

Secondary outcomes

  1. 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.

    Time frame: 3 months after vaccination

    The difference between the pneumococcal serotype-specific geometric mean antibody concentrations (GMC) for serotypes 4, 7F and 19A at three months after immunisation with a single dose of 13-valent pneumococcal conjugate vaccine (PCV13) in the children who have had a prior dose of 23-valent pneumococcal polysaccharide vaccine (PPS23) versus those who have not.

  2. Pneumococcal serotype-specific (SpVS) antibody concentrations at baseline and 12 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13).

    Time frame: 12 months after vaccination

    The proportion of children with vaccine pneumococcal serotype-specific (SpVS) antibody concentrations >0.35mcg/ml at baseline and 12 months following a single dose of 13-valent pneumococcal conjugate vaccine (PCV13).

  3. GMC of SpVS antibody at baseline, 3mnth and 12mnth following 1 dose of PCV13

    Time frame: 12 months after vaccination

    To determine the GMC, together with 95% confidence intervals, of SpVS antibody at baseline, 3mnth and 12mnth following 1 dose of PCV13

  4. 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.

    Time frame: 12 months after vaccination

    The difference between 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.

  5. 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.

    Time frame: 12 months after vaccination

    The difference between 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.

  6. Vaccine-specific serotype antibody concentration between baseline and 3 months with HbA1C.

    Time frame: 3 months after vaccination

    The correlation coefficient for the increase in VS antibody concentration between baseline and 3 months and HbA1C at baseline.

  7. Blood glucose control in the week preceding and the week following immunisation with PCV13

    Time frame: One week after vaccination

    A descriptive analysis of blood glucose control in the week preceding and the week following immunisation with PCV13

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study 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.

Acronym: T1DM

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Sep 11, 2013
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.