A Study to Assess the Carriage of Pneumococci in Children Aged 1-5 Years, and Their Household Contacts

NCT02522546 | Completed

• 1 other identifier: PIN
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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.

Conditions

Nasal Carriage of Pneumococci

Outcome Measures

Primary Outcomes (2)

• 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

  pneumococcal carriage rates for PCV13 and non-PCV13 serotypes 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.

  baseline

• invasiveness of any emerging replacement carriage serotype

  invasiveness of any emerging replacement carriage serotypes by estimating case: carrier ratio (CCR) using national surveillance data for invasive pneumococcal disease

  baseline

Secondary Outcomes (2)

• carriage rates of individual serotype

  baseline

• changes in carriage serotype

  baseline

Study Arms (1)

nasopharyngeal swab

Children ages 1-5 years and their household contacts

Other: nasopharyngeal swab

Interventions

nasopharyngeal swab OTHER

nasopharyngeal swab

Also known as: nose swab

nasopharyngeal swab

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 1-5 years and their household contacts

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Public Health England: lead

Study Sites (2)

Gloucestershire primary care

Gloucestershire, Gloucestershire, United Kingdom

Location

Hertfordshire primary care

Hertfordshire, Hertfordshire, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29799839 RESULT

Related Links

• Published study results

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal swabs

Study Officials

• Elizabeth Coates, PhD

  Public Health England

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Elizabeth Miller

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: August 13, 2015
• Study Start: July 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 22, 2019

Record last verified: 2018-08

Locations

GB (2)