Overview

This trial is active, not recruiting.

Condition nasal carriage of pneumococci
Treatment nasopharyngeal swab
Sponsor Public Health England
Start date July 2015
End date December 2016
Trial size 400 participants
Trial identifier NCT02522546, PIN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Children ages 1-5 years and their household contacts
nasopharyngeal swab nose swab
nasopharyngeal swab

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
time frame: baseline
invasiveness of any emerging replacement carriage serotype
time frame: baseline

Secondary Outcomes

Measure
carriage rates of individual serotype
time frame: baseline
changes in carriage serotype
time frame: baseline

Eligibility Criteria

Male or female participants at least 1 year old.

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.

Additional Information

Official title A Study to Assess the Carriage of Pneumococci in Children Aged 1-5 Years, and Their Household Contacts
Principal investigator Elizabeth Miller, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Public Health England.