Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT03102840 |
Other study ID # |
OVG 2017/03 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
June 26, 2017 |
Est. completion date |
October 31, 2020 |
Study information
Verified date |
October 2020 |
Source |
University of Oxford |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Streptococcus pneumoniae is a type of bacteria that is carried (lives) in the nose of most
individuals and can sometimes go on to cause severe infections such as meningitis and
pneumonia. There are over 100 types of pneumococcus, and children in the UK have been
routinely immunized against pneumococcal disease since 2006. A vaccine against 13 types of
pneumococcus (PCV 13) was introduced into the UK in 2010, replacing a previous version that
prevented 7 types.
Pneumococcal carriage in the Thames Valley region has been studied over the last 7 years with
carriage rates having been shown to be reflective of potential severe pneumococcal disease
and hence vaccine effect.
The main purpose of this study is to see whether the pneumococcal immunization program has
changed the frequency and nature of pneumococcal bacteria carried by children, as this may
give a clue as to what changes in pneumococcal disease are likely to be seen in the future.
In addition, this study is especially timely given the possibility of a change in the PCV 13
immunization schedule that is currently being assessed in the 'Sched3' Immunization study
(NCT02482636). Obtaining accurate baseline data will be important in informing the
interpretation of any subsequent data on carriage rates obtained following introduction of
the new schedule.
This study will enrol up to 1600 children aged 13 to 48 months living in the Thames Valley
and South Midlands and which have had three doses of 13-valent pneumococcal conjugate
vaccine. In addition, up to 800, 6-12 month old children who have received a priming dose of
PCV13 will be recruited. The study consists of one visit done at a convenient venue (GP
surgeries, educational/ play settings, or home) where a single nasal swab and an optional
finger-prick blood sample for a sub-set of 632 participants, will be performed. No additional
follow-up is needed. The study recruitment period will be from 2017 onwards.
Description:
This is a cross sectional observational study to determine the point prevalence of
pneumococcal carriage in children. In this study up to 1600, healthy children aged 13-48
months who have received a complete course of PCV13 at least one month prior to study
enrolment, will be recruited. In addition, up to 800, 6-12 month old children who have
received a priming dose of PCV13 will be recruited.
For the 13-48 month cohort, an interim analysis for futility to demonstrate an increase in
serotype 19A will be performed after the first 750 participants.
The study will be carried out in the Thames Valley and South Midlands. Parents/legal
guardians will be approached either by website based advertisements, social media, poster
advertisements and emailing and/or handing out information booklets through their child's
nurseries, GP Surgeries and educational/play settings. The investigators may also identify
potential participants by mailing out invitation letters and leaflets to age appropriate
children via the Open Exeter system of National Health Application and Infrastructure
Services, the Child Health Computer Department, equivalent NHS database or through the
Clinical Research Network. Parents/legal guardians of potential participants who have
expressed interest will be directed to the Oxford Vaccine group (OVG) website where they will
be able to access the participant information booklet and if appropriate complete online
self-screening. If parents approach OVG to express interest, the information booklet will be
sent to them and they may be telephone screened.
This study will involve a one off visit. The study visit will be arranged to occur in a
convenient venues such as: hospital out patients, university clinic rooms, village halls,
church halls, nurseries, participant's homes, sporting and recreational areas, GP practices
and other similar venues where pre-school children frequently attend. Permission would be
seek from the above venues to carry out any study procedures on their premises. Pre-arranged
dates and times will be offered to parents/legal guardians by online booking, phone call or
email.
During the visit the investigators would go through the details of the study and provide an
opportunity for further questions. For those willing to proceed the investigators would then
ask participants to sign a consent form and collect demographic information. A nasopharyngeal
swab will be taken, and if consented to do so an optional blood sample will be performed in a
subset of 632 participants. No further visits or follow-up will be required.