Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00952367
First received: August 3, 2009
Last updated: March 12, 2012
Last verified: March 2012

August 3, 2009
March 12, 2012
April 2009
March 2010   (final data collection date for primary outcome measure)
  • Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
carriage rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00952367 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Categories are types of antibiotics.
  • Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Categories are types of antibiotics.
  • Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
serotype [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Nasopharyngeal swab

Non-Probability Sample

Healthy Children 12 to 18 months old

Streptococcus Pneumoniae Infections
Other: Nasopharyngeal swab
Nasopharyngeal swab
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3641
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
12 Months to 18 Months
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00952367
0887X1-4602
No
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP