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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3641 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Streptococcus Pneumoniae Infections

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Nasopharyngeal swab

Intervention Type OTHER

Nasopharyngeal swab

Interventions

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Nasopharyngeal swab

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes