Effect of Prevnar 13 on Ear Infections in Children
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ClinicalTrials.gov Identifier: NCT01199016 |
Recruitment Status :
Completed
First Posted : September 10, 2010
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
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Condition or disease | Intervention/treatment |
---|---|
Otitis Media | Procedure: Tympanocentesis Procedure: Nose/throat swab Biological: Observational |
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 |

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 |
- 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.
- 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.
- 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.
- 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

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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 |
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.

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
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 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Acute otitis media Prevnar 13 Streptococcus pneumoniae nasopharyngeal colonization. |
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |