Pneumococcal DiseasePneucastNCT01040143
A Study to Assess the Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci
An observational study of Pneumococcal Disease, run by Public Health England at 3 sites in United Kingdom.
Trial summary
A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- How many people
- 450 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Jan 2008to Mar 2010
- 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: Community samples taken within the home of eligible subjects.
Who may be able to join
- Born in a cohort eligible for routine or catch up pneumococcal conjugate vaccination (i.e. date of birth since 4th September 2004) or a family member where a child is eligible and has been enrolled
- Written informed consent given by the subject's parent/ legal guardian as well as assent from the child after the nature of the study has been explained to them or
- Written informed consent given by the subject after the nature of the study has been explained to them
Who cannot join
- Moderate to severe disability.
- Cerebral palsy, syndromes and neurological disorders affecting swallowing.
- Ear Nose and Throat disorders affecting the anatomy of the ear,i.e.malformed ears.
- Confirmed or suspected immunodeficiency (congenital or acquired).
- On immunosuppressive therapy.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Health Protection Agency
Gloucester
Health Protection Agency
London, NW9 5HT
Health Protection Agency
Stevenage, Hertfordshire
About this study
A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.
- Conditions
- Pneumococcal Disease
- Keywords
- Pneumococci, Streptococcus pneumoniae
- Medical subject headings
- Pneumococcal Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pneumococci in nasopharyngeal swabs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startJan 2008
- Primary completionMar 2010
- Study completionMar 2010
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 Pneumococcal DiseaseStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040143
- Sponsor's protocol ID
- PneuCaSt
- Acronym
- Pneucast
- Status last verified
- Sep 2010
- First submitted
- 28 Dec 2009
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
van Hoek AJ, Sheppard CL, Andrews NJ, Waight PA, Slack MP, Harrison TG, Ladhani SN, Miller E. Pneumococcal carriage in children and adults two years after introduction of the thirteen valent pneumococcal conjugate vaccine in England. Vaccine. 2014 Jul 23;32(34):4349-55. doi: 10.1016/j.vaccine.2014.03.017. Epub 2014 Mar 21.
PubMed 24657717
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 Impact of Pneumococcal Conjugate Vaccination Programme on the Carriage of Pneumococci
- ClinicalTrials.gov ID
- NCT01040143
- Acronym / sponsor ID
- Pneucast / PneuCaSt
- Conditions
- Pneumococcal Disease
- Keywords
- Pneumococci, Streptococcus pneumoniae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Jan 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 29 Dec 2009 (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.
A study taking swabs from the back of the nose (nasopharynx) to look at carriage of pneumococci.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community samples taken within the home of eligible subjects.
Key inclusion criteria (3 listed)
- Born in a cohort eligible for routine or catch up pneumococcal conjugate vaccination (i.e. date of birth since 4th September 2004) or a family member where a child is eligible and has been enrolled
- Written informed consent given by the subject's parent/ legal guardian as well as assent from the child after the nature of the study has been explained to them or
- Written informed consent given by the subject after the nature of the study has been explained to them
Key exclusion criteria (5 listed)
- Moderate to severe disability.
- Cerebral palsy, syndromes and neurological disorders affecting swallowing.
- Ear Nose and Throat disorders affecting the anatomy of the ear,i.e.malformed ears.
- Confirmed or suspected immunodeficiency (congenital or acquired).
- On 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.
Primary outcome
Presence of pneumococci in nasopharyngeal swabs
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 24657717van Hoek AJ, Sheppard CL, Andrews NJ, Waight PA, Slack MP, Harrison TG, Ladhani SN, Miller E. Pneumococcal carriage in children and adults two years after introduction of the thirteen valent pneumococcal conjugate vaccine in England. Vaccine. 2014 Jul 23;32(34):4349-55. doi: 10.1016/j.vaccine.2014.03.017. Epub 2014 Mar 21.
- Published study resultsLink provided by the sponsor.
Related trials for Pneumococcal Disease
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
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 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Disease, run by Public Health England at 3 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 3 inclusion and 5 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 3 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?
Presence of pneumococci in nasopharyngeal swabs. 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 NCT01040143, 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.