- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02522546
A Study to Assess the Carriage of Pneumococci in Children Aged 1-5 Years, and Their Household Contacts (PIN)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Gloucestershire, United Kingdom
- Gloucestershire Primary Care
-
Hertfordshire, United Kingdom
- Hertfordshire primary care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
nasopharyngeal swab
Children ages 1-5 years and their household contacts
|
nasopharyngeal swab
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
Time Frame: baseline
|
invasiveness of any emerging replacement carriage serotypes by estimating case: carrier ratio (CCR) using national surveillance data for invasive pneumococcal disease
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
carriage rates of individual serotype
Time Frame: baseline
|
baseline
|
|
changes in carriage serotype
Time Frame: baseline
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Elizabeth Coates, PhD, Public Health England
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PIN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nasal Carriage of Pneumococci
-
Hospices Civils de LyonCompleted
-
Assistance Publique - Hôpitaux de ParisRecruitingRectal Carriage of Carbapenemase Producing-EnterobacteriaceaeFrance
-
Centre Hospitalier Universitaire de BesanconUnknownStaphylococcus Aureus Nasal CarriageFrance
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingAdults Patients, With Fecal Carriage of Multi-Drug Resistant Enterobacterales (MDR-E)
-
Assistance Publique - Hôpitaux de ParisCompletedFecal Carriage of Multidrug-resistant BacteriaFrance
-
Sheba Medical CenterMaccabi Healthcare Services, IsraelCompletedAntibiotic Use | Carriage of Antibiotic Resistant Pathogens
-
Assiut UniversityRecruitingAnalgesia During Removal of Nasal Pack After Nasal SurgeryEgypt
-
Universitaire Ziekenhuizen KU LeuvenUnknown
-
Karnataka Institute of Medical SciencesCompletedTissue Adhesions | Nasal Synechiae | Adhesions of Nasal Cavity | Nasal AdhesionsIndia
-
Hamilton Health Sciences CorporationFirestone Institute for Respiratory HealthCompletedNasal Lavage Fluid | Eosinophils | Reproducibility of ResultsCanada
Clinical Trials on nasopharyngeal swab
-
LumiraDx UK LimitedActive, not recruitingCOVID-19United States
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Assistance Publique Hopitaux De MarseilleCompleted
-
St. Jude Children's Research HospitalNational Institute of Allergy and Infectious Diseases (NIAID); The University...Completed
-
Wyeth is now a wholly owned subsidiary of PfizerCompletedStreptococcus Pneumoniae InfectionsChina
-
Butantan InstituteCompleted
-
Medical University InnsbruckUnknown
-
Assistance Publique - Hôpitaux de ParisRecruitingSARS-CoV2 Infection | Mutation | COVID-19 Acute Respiratory Distress SyndromeFrance
-
Assistance Publique Hopitaux De MarseilleCompleted