A Study to Assess the Carriage of Pneumococci in Children Aged ≤8 Years, and Their Household Contacts

NCT03407690 | Completed

• 1 other identifier: PIN2
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 2

Brief Summary

Since the introduction of pneumococcal conjugate vaccines, this research group has conducted several carriage studies. These were at key points in the evolution of the pneumococcal immunisation schedule, with regard to the introduction of PCV7, the change to PCV13 and the impending change in number of doses of PCV13 given to infants. The last carriage study, conducted in 2015/16 identified interesting changes in carriage patterns which will further be explored by the current planned study. Nasopharyngeal swabs and saliva swabs will be taken from healthy subjects 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).

Conditions

Immunization; Infection

Outcome Measures

Primary Outcomes (1)

• pneumococcal carriage rates

  pneumococcal carriage rates for PCV13 and non-PCV13 serotypes in children and infants eligible for primary or booster immunisation with PCV 13 and their household contacts

  through study completion, expected 6 months

Study Arms (1)

PIN2 study participants

All those giving swabs for the study

Other: nasal swab

Interventions

nasal swab OTHER

collection of nasal swab to allow carriage of pneumococci to be assessed

PIN2 study participants

Eligibility Criteria

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

Study Population

• At least 200 children (index cases) aged ≤8 years and at least 200 household contacts.

You may qualify if:

• At least one child aged ≤8 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

Gloucester, Gloucestershire, United Kingdom

Location

Hertfordshire primary care

Hertford, Hertfordshire, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Swab

MeSH Terms

Conditions

Infections

Study Officials

• Elizabeth Coates, PhD

  Public Health England

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2018
• First Posted: January 23, 2018
• Study Start: February 14, 2018
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 29, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)