Clinical Trial Results:
An open label single-arm study 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.
|
Summary
|
|
EudraCT number |
2013-001024-19 |
Trial protocol |
GB |
Global end of trial date |
31 Dec 2018
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
23 Jun 2022
|
First version publication date |
23 Jun 2022
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
OVG 2013/03
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT01939522 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
University of Oxford, Research Governance, Ethics and Assurance
|
||
Sponsor organisation address |
Boundary Brook House, Churchill Drive, Oxford, United Kingdom, OX3 7LA
|
||
Public contact |
Dominic F Kelly
Oxford Vaccine Group
University of Oxford Department of Paediatrics, University of Oxford, 0044 (01865) 611400, dominic.kelly@paediatrics.ox.ac.uk
|
||
Scientific contact |
Dominic F Kelly
Oxford Vaccine Group
University of Oxford Department of Paediatrics, University of Oxford, 0044 (01865) 611400, dominic.kelly@paediatrics.ox.ac.uk
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
07 Feb 2022
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
31 Dec 2018
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
31 Dec 2018
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
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.
|
||
Protection of trial subjects |
Subjects were offered local anaesthetic cream to reduce discomfort for blood sampling where relevant as per standard clinical procedures for this group of children in clinic
|
||
Background therapy |
All children in this study were on injected insulin for treatment of type 1 diabetes mellitus | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Jun 2013
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
Yes
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
United Kingdom: 50
|
||
Worldwide total number of subjects |
50
|
||
EEA total number of subjects |
0
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
11
|
||
Adolescents (12-17 years) |
39
|
||
Adults (18-64 years) |
0
|
||
From 65 to 84 years |
0
|
||
85 years and over |
0
|
||
|
|||||||||||
|
Recruitment
|
|||||||||||
Recruitment details |
Children aged 6-17 years of age with T1DM who are under regular out-patient review by the diabetes team of the Oxford University Hospital NHS Trust, UK and the Royal Berkshire NHS Foundation Trust, UK were approached and given information during routine clinic visits. Enrollment was undertaken between FPFV and LPLV. | ||||||||||
|
Pre-assignment
|
|||||||||||
Screening details |
All children of eligible age under regular out-patient review approached during clinic visits | ||||||||||
|
Period 1
|
|||||||||||
Period 1 title |
Enrollment period (overall period)
|
||||||||||
Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
|
||||||||||
Blinding used |
Not blinded | ||||||||||
|
Arms
|
|||||||||||
|
Arm title
|
PCV13 | ||||||||||
Arm description |
Participants who were given a single dose of PCV13 | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
Prevenar13
|
||||||||||
Investigational medicinal product code |
|||||||||||
Other name |
|||||||||||
Pharmaceutical forms |
Injection
|
||||||||||
Routes of administration |
Intramuscular use
|
||||||||||
Dosage and administration details |
Single dose (0.5ml) of Prevenar13 given intramuscularly into deltoid muscle of non-dominant arm
|
||||||||||
|
|||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Enrollment period
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Children aged 6-17 years of age with T1DM who are under regular out-patient review by the diabetes team of the Oxford University Hospital NHS Trust and the Royal Berkshire NHS Foundation Trust. Eligible children will have not previously received any doses of PCV (pneumococcal conjugate vaccine) but may have been immunized with PPS23 pneumococcal polysaccharide vaccine) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Subject analysis sets
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Children 6-17 years with T1DM
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Per protocol | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Children aged 6-17 years of age with T1DM who are under regular out-patient review by the diabetes team of the Oxford University Hospital NHS Trust and the Royal
Berkshire NHS Foundation Trust and who have not previously received any doses of PCV but may have been immunised with PPS23.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
PCV13
|
||
Reporting group description |
Participants who were given a single dose of PCV13 | ||
Subject analysis set title |
Children 6-17 years with T1DM
|
||
Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Children aged 6-17 years of age with T1DM who are under regular out-patient review by the diabetes team of the Oxford University Hospital NHS Trust and the Royal
Berkshire NHS Foundation Trust and who have not previously received any doses of PCV but may have been immunised with PPS23.
|
||
|
|||||||||||||||||||||||||||||||||
End point title |
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) [1] | ||||||||||||||||||||||||||||||||
End point description |
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)
|
||||||||||||||||||||||||||||||||
End point type |
Primary
|
||||||||||||||||||||||||||||||||
End point timeframe |
Time-point for primary outcome 3-months post-immunisation (V2)
|
||||||||||||||||||||||||||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: As specified in the protocol: The primary outcome of the proportion of children with vaccine pneumococcal serotype-specific (SpVS) antibody concentrations >0.35mcg/ml at 3 months will be descriptive data |
|||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||
| Notes [2] - 43 participants provided blood samples at 3-months post-immunisation |
|||||||||||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
7 days after V1 dose of PCV13
|
||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Diary card to record solicited and unsolicited events - posted back or collected at V2 (3-months post vaccine dose)
|
||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
non-specified | ||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
1.0
|
||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Total study population
|
||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
10 Apr 2014 |
Addition of reminder letter and approval for contact to be made with parent(s) by telephone prior to their next appointment.
Submitted 26/2/14 - unfavourable opinion 14/3/14
Resubmitted 4/4/14 with following changes
‘Opt-in’ form changed to ‘reply form’ with the added option not to be contacted.
Amendment to invitation letter to make it clear that those approached can use the telephone number on the reply slip if interested, want more information, OR if they want to decline.
Amendment to protocol to emphasise that the reply form include the option to opt-out of participation.
Favourable opinion 10/4/14 |
||
26 Jun 2015 |
Submitted 15/6/15
Addition of Royal Berkshire Hospital as a recruiting site.
Amendment to the protocol to reflect addition of Royal Berkshire hospital as a recruiting site. The patient and parent information sheets were changed to be generic for use at both sites.
Changes to how participant can return the diary card.
|
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
