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| ID | Type | Description | Link |
|---|---|---|---|
| B1841034 |
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Primary Objective: Evaluation of the
- Carriage rate of Streptococcus pneumoniae in the nasopharynx of children
Secondary Objective:
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Carriage of Streptococcus Pneumoniae in Nasopharynx | Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype Distribution of Streptococcus Pneumoniae Isolates | Streptococcus pneumoniae in swab culture of nasopharynx were serotyped. The assessment included 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F, non-vaccine, non-typable and missing serotypes. Percentage of participants under different vaccine serotypes in identified isolates of streptococcus pneumonia are reported. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects aged between 2 months and 5 years attending pediatric clinics in hospitals, daycare centers, and kindergartens
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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 | Taoyuan | 333 | Taiwan |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Potential Carriers | Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Potential Carriers | Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Carriage of Streptococcus Pneumoniae in Nasopharynx | Swab cultures obtained from the nasopharynx of participants were tested for the presence of streptococcus pneumoniae strains. | Evaluable population included all the participants who met inclusion and exclusion criteria for the study. | Posted | Number | Percentage of Participants | Day 1 |
|
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | All Potential Carriers | Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchiolitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Day 1 |
| Antibiotic-Resistant Streptococcus Pneumoniae Strains | Antibiotic resistance is defined as in vitro inhibition of a particular bacterial strain by a concentration of the drug associated with high likelihood of therapeutic failure. Antibiotic resistance for streptococcus pneumoniae was assessed against Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole. The standard breakpoint value (microbial growth inhibition zone) for Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole was not more than 8, 4, 13, 15 and 15 millimeter (mm) respectively. Percentage of participants with antibiotic-resistant streptococcus pneumoniae strains are reported. The same participant may have streptococcus pneumoniae strains which is resistance to more than one antibiotic. | Day 1 |
| Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril | Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains. | Day 1 |
| Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Participants for carriage of streptococcus pneumoniae were analyzed with respect to various risk factors which included number of bathrooms, number of siblings in the family (multiple siblings), size of the house in meter square (house area), frequency of hand wash in a day, bed sharing, smoking by family member, child breast feeding (breast milk practice), daycare attendance, vaccination for flu and pneumococcus, history of otitis media and upper respiratory infection (URI), antibiotic use and influenza virus infection. | Day 1 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Serotype Distribution of Streptococcus Pneumoniae Isolates | Streptococcus pneumoniae in swab culture of nasopharynx were serotyped. The assessment included 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F, non-vaccine, non-typable and missing serotypes. Percentage of participants under different vaccine serotypes in identified isolates of streptococcus pneumonia are reported. | Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, 'N' (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx. | Posted | Number | Percentage of Carrier Participants | Day 1 |
|
|
|
| Secondary | Antibiotic-Resistant Streptococcus Pneumoniae Strains | Antibiotic resistance is defined as in vitro inhibition of a particular bacterial strain by a concentration of the drug associated with high likelihood of therapeutic failure. Antibiotic resistance for streptococcus pneumoniae was assessed against Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole. The standard breakpoint value (microbial growth inhibition zone) for Penicillin, Cefotaxime, Levofloxacin, Erythromycin and combination of Trimethoprim with sulfamethoxazole was not more than 8, 4, 13, 15 and 15 millimeter (mm) respectively. Percentage of participants with antibiotic-resistant streptococcus pneumoniae strains are reported. The same participant may have streptococcus pneumoniae strains which is resistance to more than one antibiotic. | Evaluable population included all the participants who met inclusion and exclusion criteria for the study. Here, 'N' (number of participants analyzed) signifies those participants who were carrier of streptococcus pneumoniae in nasopharynx. | Posted | Number | Percentage of Carrier Participants | Day 1 |
|
|
|
| Secondary | Percentage of Participants With Carriage of Staphylococcus Aureus in Nostril | Swab cultures obtained from the nostril of participants were tested for the presence of Staphylococcus aureus strains. | Evaluable population included all participants who met inclusion and exclusion criteria for the study. | Posted | Number | Percentage of Participants | Day 1 |
|
|
|
| Secondary | Percentage of Participants With Carriage of Streptococcus Pneumoniae Based on Risk Factors | Participants for carriage of streptococcus pneumoniae were analyzed with respect to various risk factors which included number of bathrooms, number of siblings in the family (multiple siblings), size of the house in meter square (house area), frequency of hand wash in a day, bed sharing, smoking by family member, child breast feeding (breast milk practice), daycare attendance, vaccination for flu and pneumococcus, history of otitis media and upper respiratory infection (URI), antibiotic use and influenza virus infection. | Evaluable population included all the participants who met inclusion and exclusion criteria for the study. 'n' signifies those participants who were evaluated for the respective risk factor. | Posted | Number | Percentage of Participants | Day 1 |
|
|
|
| 1 |
| 9,705 |
| 359 |
| 9,705 |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Herpangina | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Pfizer 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.
| D007239 | Infections |
| Title | Measurements |
|---|
|
| 4 |
|
| 5 |
|
| 6B |
|
| 7F |
|
| 8 |
|
| 9N |
|
| 9V |
|
| 10A |
|
| 11A |
|
| 12F |
|
| 14 |
|
| 15B |
|
| 17F |
|
| 18C |
|
| 19A |
|
| 19F |
|
| 20 |
|
| 22F |
|
| 23F |
|
| 33F |
|
| Non-vaccine serotype |
|
| Non-typable |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| Erythromycin |
|
| Trimethoprim-sulfamethoxazole |
|
| Title | Measurements |
|---|---|
|
| House area : >50 (n=4007) |
|
| Multiple siblings : >1 (n=6383) |
|
| Multiple siblings : Only 1 (n=3320) |
|
| Frequency of hand wash : Less than (<) 4 (n=2646) |
|
| Frequency of hand wash : 4 to 8 (n=5276) |
|
| Frequency of hand wash : >8 (n=1783) |
|
| Bed sharing : Yes (n=8689) |
|
| Bed sharing : No (n=1016) |
|
| Family member smoking : Yes (n=4546) |
|
| Family member smoking : No (n=5159) |
|
| Breast milk practice : Yes (n=7000) |
|
| Breast milk practice : No (n=2705) |
|
| Daycare attendance : Yes (n=1783) |
|
| Daycare attendance : No (n=7922) |
|
| Flu vaccine : Yes (n=3993) |
|
| Flu vaccine : No (n=5712) |
|
| Pneumoccal vaccine : Yes (n=2225) |
|
| Pneumoccal vaccine : No (n=7480) |
|
| Otitis media : Yes (n=894) |
|
| Otitis media : No (n=8811) |
|
| URI in last 2 weeks : Yes (n=2940) |
|
| URI in last 2 weeks : No (n=6765) |
|
| Antibiotic use : Yes (n=574) |
|
| Antibiotic use : No (n=9131) |
|
| Influenza virus infection : Yes (n=21) |
|
| Influenza virus infection : No (n=9684) |
|