PIN2

• Research type

  Research Study

• Full title

  A study to assess the carriage of pneumococci in children aged ≤8 years, and their household contacts

• IRAS ID

  241659

• Contact name

  Elizabeth Miller

• Contact email

  liz.miller@phe.gov.uk

• Sponsor organisation

  Public Health England

• Clinicaltrials.gov Identifier

  applied for, awaiting record release, ClinicalTrials.gov Identifier (NCT number):

• Duration of Study in the UK

  0 years, 6 months, 18 days

• Research summary

  Many bacteria, including a group called pneumococci, live in the nose/throat without causing a person any illness, but allow them to transmit the bacteria to others when they cough or sneeze. Pneumococcal vaccines have been shown to clear carriage of some of the strains that they include. This is important as clearing carriage stops the chain of transmission onto other people.
  Since the introduction of pneumococcal conjugate vaccines, this research group has conducted several carriage studies to assess the strains of pneumococcal bacteria that were carried in the nose of children and their household contacts. There have been several key changes in the national immunisation programme in terms of the pneumococcal vaccines given, including the introduction of a vaccine containing seven strains (PCV7), then a change to one with 13 strains (PCV13) and shortly a change in the number of doses infants are given from three to two. This group has conducted several carriage studies at key timepoints in relation to these changes which have helped inform vaccination policy.
  The last carriage study, conducted in 2015/16, identified interesting changes in carriage patterns of strains included in the vaccine in particular (manuscript in submission now) which will further be explored by the current planned study.

  One Nose swab and one saliva swab will be taken from each healthy volunteer and any pneumococci present will be cultured and serotyped using standard methods, as per our previous studies (Hussain et al., 2005; Flasche et al., 2011; van Hoek et al., 2014). Households recruited will need to have a child who is eligible for the pneumococcal vaccination (PCV13) under the national schedule, which means any child aged 8 years and under. We would collect samples, with consent and where appropriate assent, from this child and any of their household contacts who join the study.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  18/YH/0048

• Date of REC Opinion

  6 Feb 2018

• REC opinion

  Favourable Opinion