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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
History of Changes
  Purpose

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.


Condition Intervention
Streptococcus Pneumoniae Infections
 Other: Nasopharyngeal swab

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Biospecimen Retention:   Samples Without DNA

Nasopharyngeal swab


Enrollment: 3641
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
 Other: Nasopharyngeal swab
Nasopharyngeal swab

  Eligibility

Ages Eligible for Study:   12 Months to 18 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy Children 12 to 18 months old

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952367

Locations
China, Beijing
Pfizer Investigational Site
Beijing, Beijing, China, 10013
China, Guangdong
Pfizer Investigational Site
Dongguan, Guangdong, China, 523016
China, Hubei
Pfizer Investigational Site
Wuhan, Hubei, China, 430015
China, Jiangsu
Pfizer Investigational Site
Nanjing, Jiangsu, China, 210003
China, Shandong
Pfizer Investigational Site
Jinan, Shandong, China, 250001
China, Shanghai
Pfizer Investigational Site
Shanghai, Shanghai, China, 200336
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00952367     History of Changes
Other Study ID Numbers: 0887X1-4602
Study First Received: August 3, 2009
Results First Received: March 12, 2012
Last Updated: March 12, 2012
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Pneumococcal Infections
Pneumonia
Streptococcal Infections
Gram-Positive Bacterial Infections
 Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 19, 2013