Immunization; InfectionPIN2NCT03407690
A Study to Assess the Carriage of Pneumococci in Children Aged ≤8 Years, and Their Household Contacts
An observational study of Immunization; Infection, run by Public Health England at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Immunization; Infection
- What is being tested?
- nasal swab
- How many people
- 280 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 14 Feb 2018to 31 Jul 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: • At least 200 children (index cases) aged ≤8 years and at least 200 household contacts.
Who may be able to join
- 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
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
Gloucester, Gloucestershire
Hertfordshire primary care
Hertford, Hertfordshire
About this study
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).
Read the detailed description
Streptococcus pneumoniae frequently colonises the human nasopharynx and most carriers remain asymptomatic. However, sometimes the organism may spread locally to cause non-invasive, mucosal infections such as sinusitis and otitis media or may invade the bloodstream and cause serious infections, including septicaemia, meningitis and pneumonia. In the 2005/06 epidemiological year, there were 6,391 cases of invasive pneumococcal diseases in England and Wales, with the highest incidence in the first year of life. The risk of developing invasive disease is dependent on both the susceptibility of the host and the invasiveness of the pneumococcus, which is largely determined by the characteristics of its polysaccharide capsule. Of the >90 known pneumococcal serotypes, the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in the 7-valent pneumococcal conjugate vaccine (PCV7) accounted for around 75% of childhood IPD cases in England and Wales prior to routine pneumococcal vaccination.
There have been several carriage studies conducted by this group at key points in the evolution of the pneumococcal vaccination policy of the UK, before use of any PCV, once the PCV7 had been introduced and once the change to PCV13 had been made. Studies have shown that conjugate vaccines, of which PCV7 and PCV13 are examples, can affect carriage of the bacteria against which the vaccinate. This series of carriage studies is important in understanding which pneumococcal strains are in the nose and so are potentially part of the chain of transmission as the vaccinations given have changed. For pneumococcus, where there are many strains, it is important to understand whether clearing carriage of a strain contained in the vaccine creates a niche which can be exploited by a strain of greater virulence or one which causes more serious disease. Our last such study suggested there are changes which we should continue to monitor, which is why the current study is now happening.
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.
- Conditions
- Immunization; Infection
- Being tested
- nasal swab
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal swabOther
collection of nasal swab to allow carriage of pneumococci to be assessed
| Study group | Role | What they receive |
|---|---|---|
| PIN2 study participants | All those giving swabs for the study Receives: Other: nasal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, expected 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start14 Feb 2018
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunization; InfectionStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Elizabeth Coates, PhD, Study director, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407690
- Sponsor's protocol ID
- PIN2
- Acronym
- PIN2
- Status last verified
- Aug 2018
- First submitted
- 9 Jan 2018
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 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 ≤8 Years, and Their Household Contacts
- ClinicalTrials.gov ID
- NCT03407690
- Acronym / sponsor ID
- PIN2 / PIN2
- Conditions
- Immunization; Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 23 Jan 2018 (actual)
- 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.
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).
Detailed description
Streptococcus pneumoniae frequently colonises the human nasopharynx and most carriers remain asymptomatic. However, sometimes the organism may spread locally to cause non-invasive, mucosal infections such as sinusitis and otitis media or may invade the bloodstream and cause serious infections, including septicaemia, meningitis and pneumonia. In the 2005/06 epidemiological year, there were 6,391 cases of invasive pneumococcal diseases in England and Wales, with the highest incidence in the first year of life. The risk of developing invasive disease is dependent on both the susceptibility of the host and the invasiveness of the pneumococcus, which is largely determined by the characteristics of its polysaccharide capsule. Of the >90 known pneumococcal serotypes, the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in the 7-valent pneumococcal conjugate vaccine (PCV7) accounted for around 75% of childhood IPD cases in England and Wales prior to routine pneumococcal vaccination.
There have been several carriage studies conducted by this group at key points in the evolution of the pneumococcal vaccination policy of the UK, before use of any PCV, once the PCV7 had been introduced and once the change to PCV13 had been made. Studies have shown that conjugate vaccines, of which PCV7 and PCV13 are examples, can affect carriage of the bacteria against which the vaccinate. This series of carriage studies is important in understanding which pneumococcal strains are in the nose and so are potentially part of the chain of transmission as the vaccinations given have changed. For pneumococcus, where there are many strains, it is important to understand whether clearing carriage of a strain contained in the vaccine creates a niche which can be exploited by a strain of greater virulence or one which causes more serious disease. Our last such study suggested there are changes which we should continue to monitor, which is why the current study is now happening.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PIN2 study participants | – | Other: nasal swabAll those giving swabs for the study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- • At least 200 children (index cases) aged ≤8 years and at least 200 household contacts.
Key inclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| nasal swabcollection of nasal swab to allow carriage of pneumococci to be assessed | Other | PIN2 study participants |
Primary outcome
pneumococcal carriage rates
Time frame: through study completion, expected 6 months
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
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 29 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Immunization; Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Active, not recruiting
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
COVID-19
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 4
An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
HPV Infection
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 study director
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 Immunization; Infection, 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 29 Aug 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 rates (time frame: through study completion, expected 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2019.