Clinical trial NCT02522546: A Study to Assess the Carriage of Pneumococci in Children Aged 1-5 Years, and Their Household Contacts
Official title: A Study to Assess the Carriage of Pneumococci in Children Aged 1-5 Years, and Their Household Contacts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Carriage of Pneumococci
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2015-08-13
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 1-5 years and their household contacts

Brief summary: Pneumococci are bacteria which can cause serious and potentially life threatening illnesses like meningitis and blood poisoning.

Pneumococcal vaccines (PCV) have been given in the national immunisation schedule since 2006.Carriage studies allow assessment of how the strains in the nose change over time, in that by clearing some strains away which other strains take up those niches in their place both in children and in their close/household contacts. This helps to inform the best use of the vaccines available and for future vaccine development and which strains would be useful to include.

Detailed description: Pneumococci are bacteria which can cause serious and potentially life threatening illnesses like meningitis and blood poisoning. There are \~90 strains, some are more dangerous than others in the severity of the disease they cause. Around half of all children carry pneumococci at the back of their nose without any ill effect. Pneumococcal vaccines (PCV) have been given in the national immunisation schedule since 2006. Vaccines protect individuals by making antibodies to be made in the blood and these vaccines help to clear the pneumococci from the nose, which helps control disease in the population by stopping their onward transmission when children cough and sneeze. This clearing effect is specific to the strains that are included in the vaccine. The first vaccines used included seven (PCV7) strains and the one used currently includes 13 (PCV13).

This group has conducted three previous carriage studies, and this will be the fourth. The first was before any vaccine was used, the second just after PCV7 was introduced and the third after the UK moved to using PCV13. These carriage studies allow assessment of how the strains in the nose change over time, in that by clearing some strains away which other strains take up those niches in their place both in children and in their close/household contacts. This helps to inform the best use of the vaccines available and for future vaccine development and which strains would be useful to include.

All families registered at participating surgeries, with a child aged 1-5 years, will be invited to take part. The study involves a single nasopharyngeal swab and a saliva swab from the child and as many other household members as are happy to participate. Participants may be seen at their GP surgery or in the home if more mutually convenient

Eligibility criteria: Inclusion Criteria:

* At least one child aged 1 to 5 years in the household
* Written informed consent obtained from the child's parent / legal guardian for their participation, and for any participating household contacts

Exclusion Criteria:

* Moderate to severe cerebral palsy or other debilitating condition
* Syndromes and neurological disorders affecting swallowing.
* Ear, nose \& throat disorders affecting local anatomy for swabbing (e.g. malformed ears)
* Confirmed or suspected immunodeficiency (congenital or acquired) or receiving immunosuppressive therapy.

Primary outcomes:
measure: pneumococcal carriage rate in children aged 1-5 years, older children and adolescents (aged 5-20 years) and adults (aged >20 years), five years after the introduction of PCV13
timeFrame: baseline
measure: invasiveness of any emerging replacement carriage serotype
timeFrame: baseline
Secondary outcomes:
measure: carriage rates of individual serotype
timeFrame: baseline
measure: changes in carriage serotype
timeFrame: baseline
Other outcomes:
Locations:
city: Gloucestershire
country: United Kingdom
facility: Gloucestershire primary care
city: Hertfordshire
country: United Kingdom
facility: Hertfordshire primary care
Study officials:
affiliation: Public Health England
name: Elizabeth Coates, PhD
References:
citation: Southern J, Andrews N, Sandu P, Sheppard CL, Waight PA, Fry NK, Van Hoek AJ, Miller E. Pneumococcal carriage in children and their household contacts six years after introduction of the 13-valent pneumococcal conjugate vaccine in England. PLoS One. 2018 May 25;13(5):e0195799. doi: 10.1371/journal.pone.0195799. eCollection 2018.