Nasopharyngeal Carriage of Streptococcus PneumoniaeNCT01925222
Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
An observational study of Nasopharyngeal Carriage of Streptococcus Pneumoniae, run by Arto Palmu at 1 site in Finland.
Trial summary
The purpose of this study is to assess the direct effects of the ten-valent pneumococcal conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age. Read more about this study
- Who is it for?
- Ages 3 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Carriage of Streptococcus Pneumoniae
- How many people
- 3,900 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2013to 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 3 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011 and their unvaccinated older siblings.
Who may be able to join
- age 3 to 5 years
- enrolled in the FinIP trial and has received at least one dose of study vaccine in the infant vaccine schedule (3+1 or 2+1)
- at least one parent with fluent Finnish
- informed consent from one parent
- age 5 to 9 years
- younger sibling living in the same household having participated in the FinIP trial (regardless of the vaccination schedule)
- at least one parent with fluent Finnish
- informed consent from one parent
Who cannot join
- PCV vaccination administered, other than the randomized study vaccine
- history of antimicrobial treatment within 4 weeks (the child can be enrolled later)
- PCV vaccination administered
- history of antimicrobial treatment within 4 weeks (the child can be enrolled later)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study During PCV National Vaccination Programme
The purpose of this study is to assess the direct effects of the ten-valent pneumococcal conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.
These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011.
Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder non-vaccinated siblings aged 5 to 9 years.
Read the detailed description
This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2013 from vaccinated and unvaccinated children.
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 |
|---|---|---|
| PCV-vaccinated infant, 3+1 schedule | Not described | |
| PCV-vaccinated infant, 2+1 schedule | Not described | |
| Control-vaccinated infant | Not described | |
| PCV-vaccinated child, catch-up schedule | Not described | |
| Control-vaccinated child, catch-up schedule | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) in children vaccinated in infancy
Nasopharyngeal and oropharyngeal swabs taken once at 3 to 5 years of age
Measured: one sampling at 3 to 5 years of age
Secondary outcomes (1)
Carriage due to any pneumococcal serotype in children vaccinated in infancy
Measured: one sampling at 3 to 5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2013 (estimated)
- Study startAug 2013
- 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 Nasopharyngeal Carriage of Streptococcus PneumoniaeStudies 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
- Cross-sectional
- Enrolment
- 3,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arto Palmu
- Sponsor type
- Other government
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor-investigator, Arto Palmu, Finnish Institute for Health and Welfare
- Investigators
- Arto A Palmu, MD, PhD, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925222
- Sponsor's protocol ID
- FinIP-carriage13THL
- Status last verified
- Mar 2017
- First submitted
- 15 Aug 2013
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Palmu AA, Jokinen J, Borys D, Nieminen H, Ruokokoski E, Siira L, Puumalainen T, Lommel P, Hezareh M, Moreira M, Schuerman L, Kilpi TM. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet. 2013 Jan 19;381(9862):214-22. doi: 10.1016/S0140-6736(12)61854-6. Epub 2012 Nov 16.
PubMed 23158882
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study During PCV National Vaccination Programme
- ClinicalTrials.gov ID
- NCT01925222
- Acronym / sponsor ID
- FinIP-carriage13THL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,900 participants (actual)
- Lead sponsor
- Arto PalmuOther government
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Aug 2013 (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.
The purpose of this study is to assess the direct effects of the ten-valent pneumococcal conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.
These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011.
Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder non-vaccinated siblings aged 5 to 9 years.
Detailed description
This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2013 from vaccinated and unvaccinated children.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| PCV-vaccinated infant, 3+1 schedule | – | – |
| PCV-vaccinated infant, 2+1 schedule | – | – |
| Control-vaccinated infant | – | – |
| PCV-vaccinated child, catch-up schedule | – | – |
| Control-vaccinated child, catch-up schedule | – | – |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011 and their unvaccinated older siblings.
Key inclusion criteria (8 listed)
- age 3 to 5 years
- enrolled in the FinIP trial and has received at least one dose of study vaccine in the infant vaccine schedule (3+1 or 2+1)
- at least one parent with fluent Finnish
- informed consent from one parent
- age 5 to 9 years
Key exclusion criteria (4 listed)
- PCV vaccination administered, other than the randomized study vaccine
- history of antimicrobial treatment within 4 weeks (the child can be enrolled later)
- PCV vaccination administered
- history of antimicrobial treatment within 4 weeks (the child can be enrolled later)
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
Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) in children vaccinated in infancy
Time frame: one sampling at 3 to 5 years of age
Nasopharyngeal and oropharyngeal swabs taken once at 3 to 5 years of age
1 secondary outcome
Carriage due to any pneumococcal serotype in children vaccinated in infancy
Time frame: one sampling at 3 to 5 years of age
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 30 Mar 2017.
- Background: PubMed 23158882Palmu AA, Jokinen J, Borys D, Nieminen H, Ruokokoski E, Siira L, Puumalainen T, Lommel P, Hezareh M, Moreira M, Schuerman L, Kilpi TM. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet. 2013 Jan 19;381(9862):214-22. doi: 10.1016/S0140-6736(12)61854-6. Epub 2012 Nov 16.
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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.
Arto A Palmu, MD, PhD principal investigator
Finnish Institute for Health and Welfare
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 Streptococcus Pneumoniae, run by Arto Palmu at 1 site in Finland.
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 8 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 30 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 Finland. 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?
Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) in children vaccinated in infancy (time frame: one sampling at 3 to 5 years of age). 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 NCT01925222, 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 30 Mar 2017.