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

Study Overview
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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.

Official Title
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Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children Aged 12-18 Months in Six Cities of China

Conditions
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Streptococcus Pneumoniae Infections

Intervention / Treatment
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* Other: Nasopharyngeal swab


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Per-protocol population<br>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<br>* Nasopharyngeal swab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae | 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. | Day 1 | 
| Percentage of Participants With Serotypes of Streptococcus Pneumoniae | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B | 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. | Day 1 | 
| Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis | 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. | Day 1 | 
| Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics | 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. | Day 1 | 
| Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics | Categories are types of antibiotics. | Day 1 | 
| Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics | Categories are types of antibiotics. | Day 1 | 
| Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae | 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). | Day 1 | 
| Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B | 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). | Day 1 | 
| Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis | 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). | Day 1 |