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Effect of Prevnar 13 on Ear Infections in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01199016
First Posted: September 10, 2010
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
Results First Submitted: January 10, 2017  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Otitis Media
Interventions: Procedure: Tympanocentesis
Procedure: Nose/throat swab
Biological: Observational

  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
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Reporting Groups
  Description
Prevnar 13 Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).

Participant Flow:   Overall Study
    Prevnar 13
STARTED   239 
Treated   236 
COMPLETED   162 
NOT COMPLETED   77 
No longer meets eligibility criteria                4 
Entrance criteria                5 
Protocol Violation                9 
Other                13 
Withdrawal by Subject                21 
Lost to Follow-up                25 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set included all participants who had at least one dose of study drug and had undergone at least 1 of the study procedures.

Reporting Groups
  Description
Prevnar 13 Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).

Baseline Measures
   Prevnar 13 
Overall Participants Analyzed 
[Units: Participants]
 236 
Age 
[Units: Months]
Mean (Standard Deviation)
 7.4  (2.61) 
Gender 
[Units: Participants]
Count of Participants
 
Female      115  48.7% 
Male      121  51.3% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)   [ Time Frame: Baseline up to Month 36 ]

2.  Other Pre-specified:   Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants   [ Time Frame: Baseline up to Month 36 ]

3.  Other Pre-specified:   Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)   [ Time Frame: Baseline up to Month 36 ]

4.  Other Pre-specified:   Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Healthy Participants   [ Time Frame: Baseline up to Month 36 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01199016     History of Changes
Other Study ID Numbers: 6096A1-4010
B1851018 ( Other Identifier: Alias Study Number )
First Submitted: September 8, 2010
First Posted: September 10, 2010
Results First Submitted: January 10, 2017
Last Update Posted: March 1, 2017