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

Nasal Carriage of Pneumococci Clinical Trial

— PIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522546
• Other study ID #: PIN
• Status: Completed
• Start date: July 2015
• Est. completion date: December 2016

Study information

• Verified date: August 2018
• Source: Public Health England
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Carriage of Pneumococci

Intervention

Other:
• nasopharyngeal swab
nasopharyngeal swab

Locations

Country	Name	City	State
United Kingdom	Gloucestershire primary care	Gloucestershire
United Kingdom	Hertfordshire primary care	Hertfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Public Health England

Country where clinical trial is conducted

United Kingdom, 

References & 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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	carriage rates of individual serotype		baseline
Secondary	changes in carriage serotype	changes in carriage serotype, by age, vs previous carriage studies performed by the Health Protection Agency in 2001/02, 2008/09 and 2012 in children and adults. This includes changes in the prevalence of proportion and changes in the proportion of carriage strains that are vaccine and non-vaccine types	baseline

External Links

•   Published study results