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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 Description
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Brief Summary:
Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar. It is expected that the effectiveness of Prevnar 13 against ear infections in children will be similar to that observed following Prevnar. Pfizer has committed to conduct a postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.

Condition or disease Intervention/treatment
Otitis Media Procedure: Tympanocentesis Procedure: Nose/throat swab Biological: Observational

Detailed Description:
Infants who have completed the Prevnar 13 infant vaccination series who provide consent and fit the study inclusion criteria to participate in the study will be recruited.
Study Design
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Study Type : Observational
Actual Enrollment : 239 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: "a Phase 4, Postmarketing Study Evaluating The Impact Of Prevnar 13 (Trademark)(13-valent Pneumococcal Conjugate Vaccine; 13vpnc) In Reducing Acute Otitis Media And Nasopharyngeal Colonization Caused By Streptococcus Pneumoniae In Healthy Children
Study Start Date : September 2010
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
1 Procedure: Tympanocentesis
To be performed as needed on children presenting with acute otitis media

Procedure: Nose/throat swab
To be performed at every study visit

Biological: Observational
Observational Study Only


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.


Other Outcome Measures:
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.


Biospecimen Retention:   Samples Without DNA
Middle Ear Fluid for microbiologic analysis Nose and throat swab for microbiologic analysis

Eligibility Criteria
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Ages Eligible for Study:   6 Months to 30 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy children aged approximately 6 to 36 months of age.
Criteria

Inclusion Criteria:

  • Subject has received full (3-dose) infant series of Prevnar 13

Exclusion Criteria:

  • Prior vaccination with any 7vPnC.
  • Prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vPS).
  • Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01199016


Locations
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United States, New York
Penfield Pediatrics
Penfield, New York, United States, 14526
Long Pond Pediatrics
Rochester, New York, United States, 14606
Legacy Pediatrics
Rochester, New York, United States, 14618
Lewis Pediatrics
Rochester, New York, United States, 14618
Pathway Pediatrics
Rochester, New York, United States, 14618
Sunrise Pediatrics
Rochester, New York, United States, 14618
Westfall Pediatrics
Rochester, New York, United States, 14618
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01199016    
Other Study ID Numbers: 6096A1-4010
B1851018 ( Other Identifier: Alias Study Number )
First Posted: September 10, 2010    Key Record Dates
Results First Posted: March 1, 2017
Last Update Posted: March 1, 2017
Last Verified: December 2016
Keywords provided by Pfizer:
Acute otitis media
Prevnar 13
Streptococcus pneumoniae
nasopharyngeal colonization.
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases