Nasal Carriage of PneumococciPINNCT02522546
A Study to Assess the Carriage of Pneumococci in Children Aged 1-5 Years, and Their Household Contacts
An observational study of Nasal Carriage of Pneumococci, run by Public Health England at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Carriage of Pneumococci
- What is being tested?
- nasopharyngeal swab
- How many people
- 400 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children aged 1-5 years and their household contacts
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Gloucestershire primary care
Gloucestershire, Gloucestershire
Hertfordshire primary care
Hertfordshire, Hertfordshire
About this study
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.
Read the 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
- Conditions
- Nasal Carriage of Pneumococci
- Being tested
- nasopharyngeal swab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasopharyngeal swabOther
Also called nose swab
nasopharyngeal swab
| Study group | Role | What they receive |
|---|---|---|
| nasopharyngeal swab | Children ages 1-5 years and their household contacts Receives: Other: nasopharyngeal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: baseline
Secondary outcomes (2)
carriage rates of individual serotype
Measured: baseline
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal Carriage of PneumococciStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Elizabeth Miller, Public Health England
- Investigators
- Elizabeth Coates, PhD, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522546
- Sponsor's protocol ID
- PIN
- Acronym
- PIN
- Status last verified
- Aug 2018
- First submitted
- 22 Jul 2015
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29799839
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Carriage of Pneumococci in Children Aged 1-5 Years, and Their Household Contacts
- ClinicalTrials.gov ID
- NCT02522546
- Acronym / sponsor ID
- PIN / PIN
- Conditions
- Nasal Carriage of Pneumococci
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nasopharyngeal swab | – | Other: nasopharyngeal swabChildren ages 1-5 years and their household contacts |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children aged 1-5 years and their household contacts
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasopharyngeal swabAlso: nose swabnasopharyngeal swab | Other | nasopharyngeal swab |
Primary outcome
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.
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
2 secondary outcomes
carriage rates of individual serotype
Time frame: baseline
changes in carriage serotype
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Results publication: PubMed 29799839Southern 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.
- Published study resultsLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Coates, PhD
Public Health England
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Carriage of Pneumococci, run by Public Health England at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02522546, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.