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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasopharyngeal swab | Other | Nasopharyngeal swab |
|
| 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 |
| 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. |
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Inclusion Criteria
Exclusion Criteria
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Healthy Children 12 to 18 months old
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Beijing | Beijing Municipality | 10013 | China | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | Enrolled participants signed the informed consent form, satisfied all screening criteria, and were eligible to enter the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Nasopharyngeal swab
| 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 |
| Dongguan |
| Guangdong |
| 523016 |
| China |
| Pfizer Investigational Site | Wuhan | Hubei | 430015 | China |
| Pfizer Investigational Site | Nanjing | Jiangsu | 210003 | China |
| Pfizer Investigational Site | Jinan | Shandong | 250001 | China |
| Pfizer Investigational Site | Shanghai | Shanghai Municipality | 200336 | China |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | months |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per-protocol (PP): Participants who completed collection of nasopharyngeal swab sample, Epidemiology Questionnaire, and 24 hours safety observation. n=number of participants analyzed at that site. | Posted | Number | percentage of participants | Day 1 |
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| Primary | 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. | PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae isolates. | Posted | Number | percentage of participants | Day 1 |
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| Secondary | 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. | PP. n=number of participants analyzed at that site. | Posted | Number | percentage of participants | Day 1 |
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| Secondary | 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. | PP. n=number of participants analyzed at that site. | Posted | Number | percentage of participants | Day 1 |
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| Secondary | 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. | PP. Number of participants analyzed = number of participants with carriage of Streptococcus pneumoniae. | Posted | Number | percentage of isolates | Day 1 |
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| Secondary | Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics | Categories are types of antibiotics. | PP. Number of participants analyzed = number of participants with carriage of Haemophilus influenzae type B. | Posted | Number | percentage of isolates | Day 1 |
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| Secondary | Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics | Categories are types of antibiotics. | PP. Number of participants analyzed = number of participants with carriage of Moraxella catarrhalis. | Posted | Number | percentage of isolates | Day 1 |
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| Secondary | 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). | PP | Posted | Mean | Standard Error | relative risk | Day 1 |
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| Secondary | 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). | PP | Posted | Mean | Standard Error | relative risk | Day 1 |
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| Secondary | 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). | PP | Posted | Mean | Standard Error | relative risk | Day 1 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Per-protocol Population | Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation. | 0 | 3,600 | 0 | 3,600 |
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Wyeth has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Title | Measurements |
|---|---|
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| Nanjing (n=598) |
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| Wuhan (n=596) |
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| Dongguan (n=598) |
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| Title | Denominators | Categories | ||||
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| Cefatriaxone |
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| Azithromycin |
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| Ampicillin |
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| Title | Denominators | Categories | ||||
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| Cefatriaxone |
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| Azithromycin |
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| Levofloxacin |
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| Erythromycin |
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