Nasopharyngeal Carriage of S. PneumoniaeNCT01109108
Streptococcus Pneumonia: Effects of PCV13 on Pneumococcal Carriage
An observational study of Nasopharyngeal Carriage of S. Pneumoniae, run by Boston Medical Center at 1 site in United States.
Trial summary
The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children < 5. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carriage of S. Pneumoniae
- How many people
- 9,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Mar 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: children < 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to particpate
Who may be able to join
- children < 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to participate
Who cannot join
- children with facial malformations making NP sampling unacceptable
- children in foster care
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Primary Care, Boston Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Streptococcus Pneumonia: Herd Effects and Emergence of Potentially Virulent Serotypes PCV13_Impact of NP Colonization, Herd Effects and Emergence of Potentially Virulent Serotypes of Pneumococci
The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children < 5.
Specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotypes and decline in carriage. The study has been extended to complete 5 years of surveillance to determine the new SP serotype distribution at the time presumably a new equilibrium has been achieved.
- Conditions
- Nasopharyngeal Carriage of S. Pneumoniae
- Keywords
- pneumococcal vaccine, nasopharyngeal carriage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children <2 years of age | Children <2 years of age with and without respiratory tract infection | |
| Children 2<5 years of age | Children 2<5 years of age with and without respiratory tract infection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasopharngeal Colonization With PCV13 S. Pneumoniae
Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae
Measured: Study years 1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasopharyngeal Carriage of S. PneumoniaeStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Stephen Pelton, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109108
- Sponsor's protocol ID
- H-28757
- Status last verified
- Jan 2017
- First submitted
- 21 Apr 2010
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Streptococcus Pneumonia: Herd Effects and Emergence of Potentially Virulent Serotypes PCV13_Impact of NP Colonization, Herd Effects and Emergence of Potentially Virulent Serotypes of Pneumococci
- ClinicalTrials.gov ID
- NCT01109108
- Acronym / sponsor ID
- H-28757
- Conditions
- Nasopharyngeal Carriage of S. Pneumoniae
- Keywords
- pneumococcal vaccine, nasopharyngeal carriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Apr 2010
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Posted 14 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aim is to evaluate the impact of PCV13 as administered in the pediatric primary care clinic at Boston medical center on the serotype specific carriage of Streptococcus pneumoniae in children < 5.
Specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotypes and decline in carriage. The study has been extended to complete 5 years of surveillance to determine the new SP serotype distribution at the time presumably a new equilibrium has been achieved.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children <2 years of age | – | –Children <2 years of age with and without respiratory tract infection |
| Children 2<5 years of age | – | –Children 2<5 years of age with and without respiratory tract infection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children < 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to particpate
Key inclusion criteria (1 listed)
- children < 5 years of age receiving care at Primary Care center at BMC and as many parent(s) as willing to participate
Key exclusion criteria (2 listed)
- children with facial malformations making NP sampling unacceptable
- children in foster care
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
Nasopharngeal Colonization With PCV13 S. Pneumoniae
Time frame: Study years 1-5
Proportion of PCV13 serotypes among n=1851 children colonized with any S. pneumoniae
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carriage of S. Pneumoniae, run by Boston Medical Center at 1 site in United States.
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 1 inclusion and 2 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 14 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Nasopharngeal Colonization With PCV13 S. Pneumoniae (time frame: Study years 1-5). 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 14 Mar 2017.