Understanding Pneumococcal Carriage and Disease 2017-2020
United Kingdom2,400 participantsStarted 2017-06-26
Plain-language 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.
Who can participate
Age range6 Months ā 48 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Parent/guardian of participant is willing and able to give informed consent for participation in the study.
ā. In good health as determined by a brief medical history and/or clinical judgement of the investigator.
ā. For children aged 13-48months, they must have received three doses of PCV13 as per infant immunization schedule (as confirmed by red book or through vaccination history and age). For children aged 6-12months, they must have received 2 doses of PCV12 as per the infant immunisation schedule.
ā. Aged 13-48 months and at least 28 days since their third PCV13 vaccination or aged 6-12months and at least 28days since their second dose of PCV13.
ā. Able (in the Investigators opinion) and willing to comply with all study requirements.
Exclusion criteria
ā. Parent/legal guardian unwilling or unable to give written informed consent to participate in the study.
ā. Parent/legal guardian less than 18 years of age at time of enrolment.
ā. Parent/legal guardian is listed on the study delegation log.
What they're measuring
1
Serotype 19A-specific carriage rate in healthy children aged 6 to 48 months in 2017-2020.
ā. Children who were known to be un-immunized or have an incomplete course of PCV13.
ā. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
ā. History of bleeding disorder.
ā. Febrile illness or temperature of 38Ā°C or above on the day of the visit or in the preceding 24 hours.
ā. Respiratory illness on the day of the study visit or in the preceding 24 hours. A respiratory illness will be classified as a combination of at least two of the following symptoms: cough, sore throat, and runny nose.