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Trial record 29 of 449 for:    OTITIS

Effect of Prevnar 13 on Ear Infections in Children

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.
 
ClinicalTrials.gov Identifier: NCT01199016
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Otitis Media
Interventions Procedure: Tympanocentesis
Procedure: Nose/throat swab
Biological: Observational
Enrollment 239
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prevnar 13
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 239
Treated 236
Completed 162
Not Completed 77
Reason Not Completed
No longer meets eligibility criteria             4
Entrance criteria             5
Protocol Violation             9
Other             13
Withdrawal by Subject             21
Lost to Follow-up             25
Arm/Group Title Prevnar 13
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 236
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 236 participants
7.4  (2.61)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 236 participants
Female
115
  48.7%
Male
121
  51.3%
1.Primary Outcome
Title 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)
Hide Description MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.
Time Frame Baseline up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
MEF AOM population included all participants with at least 1 MEF sample from an episode of AOM. In this analysis, 'Number of MEF samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae serotypes 1, 3, 5, 6A, 7F, or 19A.
Arm/Group Title Prevnar 13
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 90
Overall Number of Units Analyzed
Type of Units Analyzed: MEF Samples
53
Measure Type: Number
Unit of Measure: percentage of MEF samples
7.5
2.Other Pre-specified Outcome
Title Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants
Hide Description Total percentage of NP/OP samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.
Time Frame Baseline up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
NP/OP healthy population included all participants with an NP/OP swab collection at a healthy visit. In this analysis, 'Number of NP/OP samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae serotypes 1, 3, 5, 6A, 7F, or 19A.
Arm/Group Title Prevnar 13
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 228
Overall Number of Units Analyzed
Type of Units Analyzed: NP/OP Samples
383
Measure Type: Number
Unit of Measure: percentage of NP/OP samples
6.0
3.Other Pre-specified Outcome
Title 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)
Hide Description MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.
Time Frame Baseline up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
MEF AOM population included all participants with at least 1 MEF sample from an episode of AOM. In this analysis, 'Number of MEF samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae.
Arm/Group Title Prevnar 13
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 90
Overall Number of Units Analyzed
Type of Units Analyzed: MEF Samples
53
Measure Type: Number
Unit of Measure: percentage of MEF samples
92.5
4.Other Pre-specified Outcome
Title 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
Hide Description Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.
Time Frame Baseline up to Month 36
Hide Outcome Measure Data
Hide Analysis Population Description
NP/OP healthy population included all participants with an NP/OP swab collection at a healthy visit. In this analysis, 'Number of NP/OP samples analyzed' indicates those samples that tested positive for Streptococcus pneumoniae.
Arm/Group Title Prevnar 13
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 228
Overall Number of Units Analyzed
Type of Units Analyzed: NP/OP Samples
383
Measure Type: Number
Unit of Measure: percentage of NP/OP samples
94.0
Time Frame [Not Specified]
Adverse Event Reporting Description Only protocol-related adverse events (AEs) or research-related injury (RRIs) were planned to be collected.
 
Arm/Group Title Prevnar 13
Hide Arm/Group Description 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).
All-Cause Mortality
Prevnar 13
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Prevnar 13
Affected / at Risk (%)
Total   0/239 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Prevnar 13
Affected / at Risk (%)
Total   0/239 (0.00%) 
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01199016    
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
Results First Posted: March 1, 2017
Last Update Posted: March 1, 2017