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Trial record 1 of 1 for:    NCT00952367
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Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China

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ClinicalTrials.gov Identifier: NCT00952367
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : April 23, 2012
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date August 3, 2009
First Posted Date August 6, 2009
Results First Submitted Date March 12, 2012
Results First Posted Date April 23, 2012
Last Update Posted Date April 23, 2012
Study Start Date April 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2012)
  • Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae [ 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 Streptococcus pneumoniae. Percentage of participants in whom Streptococcus pneumoniae was isolated is reported by site.
  • Percentage of Participants With Serotypes of Streptococcus Pneumoniae [ Time Frame: Day 1 ]
    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.
Original Primary Outcome Measures
 (submitted: August 3, 2009)
carriage rate [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures
 (submitted: March 12, 2012)
  • 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.
  • Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis [ 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 Moraxella catarrhalis. Percentage of participants in whom Moraxella catarrhalis was isolated is reported by site.
  • Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics [ Time Frame: Day 1 ]
    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.
  • Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics [ Time Frame: Day 1 ]
    Categories are types of antibiotics.
  • Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics [ Time Frame: Day 1 ]
    Categories are types of antibiotics.
  • Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae [ Time Frame: Day 1 ]
    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).
  • Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B [ Time Frame: Day 1 ]
    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).
  • Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis [ Time Frame: Day 1 ]
    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).
Original Secondary Outcome Measures
 (submitted: August 3, 2009)
serotype [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
Official Title Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Nasopharyngeal swab
Sampling Method Non-Probability Sample
Study Population Healthy Children 12 to 18 months old
Condition Streptococcus Pneumoniae Infections
Intervention Other: Nasopharyngeal swab
Nasopharyngeal swab
Study Groups/Cohorts 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.
Intervention: Other: Nasopharyngeal swab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 12, 2012)
3641
Original Estimated Enrollment
 (submitted: August 3, 2009)
3600
Actual Study Completion Date March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Months to 18 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT00952367
Other Study ID Numbers 0887X1-4602
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date March 2012