Pneumococcal DiseaseNCT01111214
Child Pneumococcal Serotype Epidemiology In Greece
An observational study of Pneumococcal Disease, run by Pfizer at 9 sites in Greece.
Trial summary
Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia, and pneumococcal meningitis among infants and children worldwide. The 7-valent conjugate pneumococcal vaccine (Prevenar) has been introduced in the Greek Market in 2004. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Pneumococcal Disease
- How many people
- 457 participants
- Where
- 9 sitesGreece
- Study dates
- Nov 2011to Nov 2012
- 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 Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Hospitalized children in participating centers
Who may be able to join
- Children aged 14 years old or less.
- Hospitalized in a participating healthcare facility with an IPD.
- IPD will be confirmed by isolation of S. pneumoniae from a sterile body site.
Who cannot join
- Children > 14 years of age
- Unconfirmed IPD
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Greece9 sites
University Hospital of Alexandroupolis
Alexandroupoli, 68100
Agia Sophia Children's Hospital
Athens, Attica, 115 27
University Hospital of Herakleion
Heraklion, Herakleion, 70013
Venizeleion General Hospital of Herakleion
Heraklion, Herakleion, 71409
University Hospital of Ioannina
Ioannina, Ioannina, 45332
University of Thessaly School of Medicine
Larissa, 415 00
Ahepa Hospital Paediatric Outpatient Special Clinic 1st Kyri
Thessaloniki, Thessaloniki, 54636
Ippokrateion Peripheral Hospital of Thessaloniki
Thessaloniki, Thessaloniki, 54642
Peripheral Hospital of Trikala
Trikala, Trikala, 42100
About this study
Official title: Incidence And Serotypes Of Invasive Pneumococcal Disease, After The Introduction Of The Heptavalent Conjugated Vaccine In Greece
Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia, and pneumococcal meningitis among infants and children worldwide. The 7-valent conjugate pneumococcal vaccine (Prevenar) has been introduced in the Greek Market in 2004. Additionally, as of 2006 Prevenar has been included in the Greek National Immunization Program.
The effect of the mass vaccination on the incidence of pneumococcal serotypes involved in the occurring invasive pneumococcal disease, is an important factor to consider for the introduction of the 13-valent pneumococcal conjugate vaccine.
Read the detailed description
open label, one group Purposive sampling of hospitalized children ≤14 years of age with confirmed IPD
- Conditions
- Pneumococcal Disease
- Being tested
- no intervention
- Keywords
- Invasive Pneumococcal Disease (IPD), pneumococcal serotypes
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
There is no intervention. This is a non interventional study.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Hospitalized children ≤14 years of age with invasive pneumococcal disease Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The serotype distribution of invasive S. pneumoniae isolates of hospitalized children up to 14 years of age after the introduction of the 7-valent conjugate pneumococcal vaccine
Measured: yearly
Secondary outcomes (3)
Serotype distribution of resistant S. pneumoniae isolates
Measured: yearly
Serotype distribution of IPD between immunized and non immunized children ≤14 years of age
Measured: yearly
Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin
Measured: yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Time perspective
- Retrospective
- Enrolment
- 457 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111214
- Sponsor's protocol ID
- 0887X1-4434
- Other IDs
- B1841010
- Status last verified
- Jan 2013
- First submitted
- 23 Apr 2010
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence And Serotypes Of Invasive Pneumococcal Disease, After The Introduction Of The Heptavalent Conjugated Vaccine In Greece
- ClinicalTrials.gov ID
- NCT01111214
- Acronym / sponsor ID
- 0887X1-4434
- Conditions
- Pneumococcal Disease
- Keywords
- Invasive Pneumococcal Disease (IPD), pneumococcal serotypes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 457 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 27 Apr 2010 (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.
Streptococcus pneumoniae is a major cause of pneumonia, sepsis, bacteremia, and pneumococcal meningitis among infants and children worldwide. The 7-valent conjugate pneumococcal vaccine (Prevenar) has been introduced in the Greek Market in 2004. Additionally, as of 2006 Prevenar has been included in the Greek National Immunization Program.
The effect of the mass vaccination on the incidence of pneumococcal serotypes involved in the occurring invasive pneumococcal disease, is an important factor to consider for the introduction of the 13-valent pneumococcal conjugate vaccine.
Detailed description
open label, one group Purposive sampling of hospitalized children ≤14 years of age with confirmed IPD
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: no interventionHospitalized children ≤14 years of age with invasive pneumococcal disease |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Hospitalized children in participating centers
Key inclusion criteria (3 listed)
- Children aged 14 years old or less.
- Hospitalized in a participating healthcare facility with an IPD.
- IPD will be confirmed by isolation of S. pneumoniae from a sterile body site.
Key exclusion criteria (2 listed)
- Children > 14 years of age
- Unconfirmed IPD
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 |
|---|---|---|
| no interventionThere is no intervention. This is a non interventional study. | Other | group 1 |
Primary outcome
The serotype distribution of invasive S. pneumoniae isolates of hospitalized children up to 14 years of age after the introduction of the 7-valent conjugate pneumococcal vaccine
Time frame: yearly
3 secondary outcomes
Serotype distribution of resistant S. pneumoniae isolates
Time frame: yearly
Serotype distribution of IPD between immunized and non immunized children ≤14 years of age
Time frame: yearly
Antimicrobial susceptibilities of IPD isolates and rates of resistance to penicillin
Time frame: yearly
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 10 Jan 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
9 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 Pfizer at 9 sites in Greece.
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 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 10 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Greece. 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?
The serotype distribution of invasive S. pneumoniae isolates of hospitalized children up to 14 years of age after the introduction of the 7-valent conjugate pneumococcal vaccine (time frame: yearly). 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 10 Jan 2013.