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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
Results First Received: March 12, 2012  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Streptococcus Pneumoniae Infections
Intervention: Other: Nasopharyngeal swab

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
All Enrolled Participants Enrolled participants signed the informed consent form, satisfied all screening criteria, and were eligible to enter the study.

Participant Flow:   Overall Study
    All Enrolled Participants  
STARTED     3641  
COMPLETED     3635  
NOT COMPLETED     6  
Withdrawal by Subject                 2  
Noncoordination                 1  
Protocol Violation                 3  



  Baseline Characteristics
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Reporting Groups
  Description
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.

Baseline Measures
    Per-protocol Population  
Number of Participants  
[units: participants]
 		  3600  
Age  
[units: months]
Mean ± Standard Deviation 		  14.9  ± 2.1  
Gender  
[units: participants]
 		 
Female     1718  
Male     1882  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae   [ Time Frame: Day 1 ]
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2.  Primary:   Percentage of Participants With Serotypes of Streptococcus Pneumoniae   [ Time Frame: Day 1 ]
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3.  Secondary:   Percentage of Participants With Nasopharyngeal Carriage of Haemophilus Influenzae Type B   [ Time Frame: Day 1 ]
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4.  Secondary:   Percentage of Participants With Nasopharyngeal Carriage of Moraxella Catarrhalis   [ Time Frame: Day 1 ]
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5.  Secondary:   Percentage of Streptococcus Pneumoniae Isolates Resistant to Antibiotics   [ Time Frame: Day 1 ]
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6.  Secondary:   Percentage of Haemophilus Influenzae Type B Isolates Resistant to Antibiotics   [ Time Frame: Day 1 ]
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7.  Secondary:   Percentage of Moraxella Catarrhalis Isolates Resistant to Antibiotics   [ Time Frame: Day 1 ]
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8.  Secondary:   Risk Factors Associated With Nasopharyngeal Carriage for Streptococcus Pneumoniae   [ Time Frame: Day 1 ]
  Show Outcome Measure 8

9.  Secondary:   Risk Factors Associated With Nasopharyngeal Carriage for Haemophilus Influenzae Type B   [ Time Frame: Day 1 ]
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10.  Secondary:   Risk Factors Associated With Nasopharyngeal Carriage for Moraxella Catarrhalis   [ Time Frame: Day 1 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


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