Pneumococcal DiseasePneumococciNCT00843895
Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years
A study testing pneumococcal conjugate vaccine(prevenar) in people with Pneumococcal Disease, run by King Saud University.
Trial summary
The purpose of this study is to identify the S. pneumoniae serotypes strains and to determine antibiotic susceptibility. Read more about this study
- Who is it for?
- Ages 3 weeks to 5 years
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- pneumococcal conjugate vaccine(prevenar)
- Type of treatment
- Vaccines
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Dec 2009
- Phase
- Interventional
- 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 weeks to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age less than 5 years
Who cannot join
- none
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serotyping of Pneumococci
The purpose of this study is to identify the S. pneumoniae serotypes strains and to determine antibiotic susceptibility.
- Conditions
- Pneumococcal Disease
- Being tested
- pneumococcal conjugate vaccine(prevenar)
- Keywords
- Laboratory based study, antibiotic susceptibilty, invasive strains
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumococcal conjugate vaccine(prevenar)Biological
to see the vaccine impact on pneumococcal diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and serotypes of invasive pneumococcal dis.
Measured: 6-8 months
Secondary outcomes (1)
Antibiotic susceptibility
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionAug 2009 (estimated)
- Study completionDec 2009 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843895
- Sponsor's protocol ID
- kingsadu
- Acronym
- Pneumococci
- Status last verified
- Feb 2009
- First submitted
- 9 Feb 2009
- Last updated
- 13 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotyping of Pneumococci
- ClinicalTrials.gov ID
- NCT00843895
- Acronym / sponsor ID
- Pneumococci / kingsadu
- Conditions
- Pneumococcal Disease
- Keywords
- Laboratory based study, antibiotic susceptibilty, invasive strains
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 13 Feb 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.
The purpose of this study is to identify the S. pneumoniae serotypes strains and to determine antibiotic susceptibility.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 3 weeks to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- age less than 5 years
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| pneumococcal conjugate vaccine(prevenar)to see the vaccine impact on pneumococcal diseases | Biological | – |
Primary outcome
Incidence and serotypes of invasive pneumococcal dis.
Time frame: 6-8 months
1 secondary outcome
Antibiotic susceptibility
Time frame: 6-8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
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.
Questions about this trial
What is this clinical trial studying?
A study testing pneumococcal conjugate vaccine(prevenar) in people with Pneumococcal Disease, run by King Saud University.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atef M. Shibl, PH D (00966505 30 2775, amshibl@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and serotypes of invasive pneumococcal dis. (time frame: 6-8 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 13 Feb 2009.