Impact 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: NCT01272999 |
Recruitment Status
:
Completed
First Posted
: January 10, 2011
Last Update Posted
: September 12, 2014
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Acute Otitis Media Mastoiditis |
Study Type : | Observational |
Actual Enrollment : | 391 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Postmarketing Observational Study Of The Impact Of Prevnar 13 (Pneumococcal 13 Valent Conjugate Vaccine) On Otitis Media In Children |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Group/Cohort |
---|
1
Otitis media cases
|
- S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (12 months from study start) ]
- S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (24 months from study start) ]
- S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (36 months from study start) ]
- The antimicrobial susceptibility patterns for each isolate [ Time Frame: Study Completion (36 months from study start) ]
- The primary clinical diagnosis of each child from whom S pneumoniae is isolated [ Time Frame: Study Completion (36 months from study start) ]
Biospecimen Retention: None Retained

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Weeks to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Case eligibility should be based on microbiologic data and should be reviewed and documented by an appropriately qualified member of the investigator's study team before cases are included in the study database.
- S pneumoniae identified from middle ear fluid or mastoiditis sample.
- Specimen obtained from children aged up to 18 years.
Exclusion Criteria:
- As this is an observational, laboratory based database study, there are no exclusion criteria

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): NCT01272999
United States, Arkansas | |
Arkansas Children's Hospital | |
Little Rock, Arkansas, United States, 72202 | |
United States, California | |
Children's Hospital of Los Angeles - University of Southern California School of Medicine | |
Los Angeles, California, United States, 90027 | |
Rady Children's Hospital - San Diego | |
San Diego, California, United States, 92123 | |
United States, Illinois | |
Children's Memorial Hospital | |
Chicago, Illinois, United States, 60614 | |
United States, North Carolina | |
Brenner Children's Hospital - Wake Forest University School of Medicine | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Ohio | |
Nationwide Children's Hospital - Ohio State University of Medicine and Public Health | |
Columbus, Ohio, United States, 43205 | |
United States, Pennsylvania | |
Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center | |
Pittsburgh, Pennsylvania, United States, 15224 | |
United States, Texas | |
Texas Children's Hospital - Feigin Center | |
Houston, Texas, United States, 77030 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT01272999 History of Changes |
Other Study ID Numbers: |
6096A1-4024 B1851040 |
First Posted: | January 10, 2011 Key Record Dates |
Last Update Posted: | September 12, 2014 |
Last Verified: | September 2014 |
Keywords provided by Pfizer:
Acute otitis media Prevnar 13 Streptococcus pneumoniae |
Additional relevant MeSH terms:
Otitis Otitis Media Mastoiditis Ear Diseases Otorhinolaryngologic Diseases Osteomyelitis Bone Diseases, Infectious |
Infection Bone Diseases Musculoskeletal Diseases Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |