Healthy SubjectsCarriageNCT00768833
Study Evaluating the Nasopharyngeal Carriage in Healthy Children
An observational study of Healthy Subjects, run by Pfizer at 1 site in Germany.
Trial summary
The purpose of this study is to assess the prevalence of pneumococcal stereotypes in the nasopharynx of healthy children and to describe the changes of nasopharyngeal carriage at different ages over time. Read more about this study
- Who is it for?
- Ages 3 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- How many people
- 242 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2008to Aug 2014
- 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 4 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: community sample
Who may be able to join
- Main inclusion criteria:
- Age at enrolment 3 to 4 month Main
Who cannot join
- Malformation or injury of the nasopharynx
- Known or suspected immunodeficiency
- Relevant immunosuppression
- Use of antibiotics up to 10 days prior to study inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasopharyngeal Carriage in Children After Introduction of General Pneumococcal Immunization in Germany
The purpose of this study is to assess the prevalence of pneumococcal stereotypes in the nasopharynx of healthy children and to describe the changes of nasopharyngeal carriage at different ages over time.
- Conditions
- Healthy Subjects
- Keywords
- S.pneumoniae healthy subjects, Healthy subjects
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and frequency of S. pneumonia positive serotypes
Measured: 57 months
Secondary outcomes (1)
Changes in number and frequency of S. pneumonia positive children at different ages over time
Measured: 57 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 242 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
- NCT00768833
- Sponsor's protocol ID
- 0887X1-4453
- Acronym
- Carriage
- Status last verified
- Aug 2014
- First submitted
- 7 Oct 2008
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasopharyngeal Carriage in Children After Introduction of General Pneumococcal Immunization in Germany
- ClinicalTrials.gov ID
- NCT00768833
- Acronym / sponsor ID
- Carriage / 0887X1-4453
- Conditions
- Healthy Subjects
- Keywords
- S.pneumoniae healthy subjects, Healthy subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Oct 2008 (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 prevalence of pneumococcal stereotypes in the nasopharynx of healthy children and to describe the changes of nasopharyngeal carriage at different ages over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- community sample
Key inclusion criteria (2 listed)
- Age at enrolment 3 to 4 month Main
Key exclusion criteria (4 listed)
- Malformation or injury of the nasopharynx
- Known or suspected immunodeficiency
- Relevant immunosuppression
- Use of antibiotics up to 10 days prior to study inclusion
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
Number and frequency of S. pneumonia positive serotypes
Time frame: 57 months
1 secondary outcome
Changes in number and frequency of S. pneumonia positive children at different ages over time
Time frame: 57 month
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 21 Aug 2014.
- 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
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 Healthy Subjects, run by Pfizer at 1 site in Germany.
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 2 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 21 Aug 2014. 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 Germany. 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?
Number and frequency of S. pneumonia positive serotypes (time frame: 57 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 21 Aug 2014.