- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00952367
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
March 12, 2012 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China
This study is to observe the carriage rate of Streptococcus pneumoniae (S.p.), Haemophilus influenzae Type B (Hib) and Moraxella catarrhalis (M.Cat.) in healthy Chinese children aged 12-18 months in order to estimate the prevalence of pathogens that commonly cause infection in Chinese young children.
The antibiotic resistance of all isolates and the serotypes distribution of S.p. isolates will also be tested.
Potential risk factors for nasopharyngeal carriage will be collected.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
3641
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 10013
- Pfizer Investigational Site
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Guangdong
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Dongguan, Guangdong, China, 523016
- Pfizer Investigational Site
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Hubei
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Wuhan, Hubei, China, 430015
- Pfizer Investigational Site
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Jiangsu
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Nanjing, Jiangsu, China, 210003
- Pfizer Investigational Site
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Shandong
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Jinan, Shandong, China, 250001
- Pfizer Investigational Site
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Shanghai
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Shanghai, Shanghai, China, 200336
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy Children 12 to 18 months old
Description
Inclusion Criteria
- Healthy children aged 12-18 months
Exclusion Criteria
- Use of antibiotics up to 15 days prior to study inclusion
- Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible
- Children with chronic infectious (chronic otitis media or chronic sinusitis prior to study inclusion.
- Received any pneumococcal vaccine in the past.
- Children who have already provided a NP sample in the same study period.
- Any relevant hemorrhagic disorder.
- Any febrile process (fever ≥ 38°C) at time of screening.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Per-protocol population
In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample.
The record presents demographic and result data for 3600 participants in the per-protocol population.
These participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
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Nasopharyngeal swab
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae
Time Frame: Day 1
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A nasopharyngeal swab sample approached via the nasal route was collected.
Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Streptococcus pneumoniae.
Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.
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Day 1
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Percentage of Participants With Serotypes of Streptococcus Pneumoniae
Time Frame: Day 1
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Categories are the serotypes of Streptococcus pneumoniae.
NO6A/NO6B belongs to Group 6 but is neither 6A nor 6B.
NO23F belongs to Group 23 but is not 23F.
NO19A/NO19F belongs to Group 19 but is neither 19A nor 19F.
Serotypes G, H, D, I, E, F are results of latex agglutination test, and do not refer to a specific serotype; they cannot be further serotyped by the Quellung reaction.
NO(Without capsule) includes all Streptococcus pneumoniae isolates that cannot be serotyped because of no capsule.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B
Time Frame: Day 1
|
A nasopharyngeal swab sample approached via the nasal route was collected.
Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Haemophilus influenzae type B. Percentage of participants in whom Haemophilus influenzae type B was isolated is reported by site.
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Day 1
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Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis
Time Frame: Day 1
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A nasopharyngeal swab sample approached via the nasal route was collected.
Swab samples were inoculated directly on plates and transferred to local laboratory for culture and isolation of Moraxella catarrhalis.
Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.
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Day 1
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Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics
Time Frame: Day 1
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Categories are types of antibiotics.
Penicillin (Old Criteria): Criteria of non-meningitis Streptococcus pneumoniae isolates resistant to penicillin were changed in Clinical Laboratory and Standards Institute (CLSI) in 2008.
Criteria in CLSI before 2008 were the old criteria.
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Day 1
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Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics
Time Frame: Day 1
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Categories are types of antibiotics.
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Day 1
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Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics
Time Frame: Day 1
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Categories are types of antibiotics.
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Day 1
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Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae
Time Frame: Day 1
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Risk factors include age of mother bearing (less than or equal to [<=] 30 years versus [vs] more than [>] 30 years); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); family monthly income per capita (below 600 Chinese Renminbi [RMB], 600 RMB to 1999 RMB, 2000 RMB to 4999 RMB, 5000 RMB to 7999 RMB, 8000 RMB to 9999 RMB vs more than or equal to [>=] 10000 RMB); whether have brothers or sisters (yes vs no).
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Day 1
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Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B
Time Frame: Day 1
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Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); feeding manners within 6 months (pure breast feeding, mixed feeding vs pure formula milk feeding); father's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university vs postgraduate and above); living space per capita (continuous variables); vaccination history of Haemophilus influenzae type B (Hib) (no vs yes).
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Day 1
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Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis
Time Frame: Day 1
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Risk factors include birth information (preterm vs full-term birth); household register (local vs nonlocal); mother's education level (illiteracy, elementary school, junior middle school, senior/vocational high school or technical, college/university, vs postgraduate and above); whether have brothers or sisters (no vs yes).
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Day 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
August 3, 2009
First Submitted That Met QC Criteria
August 3, 2009
First Posted (Estimate)
August 6, 2009
Study Record Updates
Last Update Posted (Estimate)
April 23, 2012
Last Update Submitted That Met QC Criteria
March 12, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0887X1-4602
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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