Impact of Prevnar 13 on Ear Infections in Children
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01272999
First received: December 8, 2010
Last updated: September 10, 2014
Last verified: September 2014
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Purpose
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 |
|---|
|
Acute Otitis Media Mastoiditis |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (12 months from study start) ] [ Designated as safety issue: No ]
- S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (24 months from study start) ] [ Designated as safety issue: No ]
- S pneumoniae serotype for each isolate assayed [ Time Frame: Annual (36 months from study start) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The antimicrobial susceptibility patterns for each isolate [ Time Frame: Study Completion (36 months from study start) ] [ Designated as safety issue: No ]
- The primary clinical diagnosis of each child from whom S pneumoniae is isolated [ Time Frame: Study Completion (36 months from study start) ] [ Designated as safety issue: No ]
Biospecimen Retention: None Retained
Microbiology samples (middle ear fluid) taken by treating physicians in standard course of care for ear infections.
| Enrollment: | 391 |
| Study Start Date: | December 2010 |
| Study Completion Date: | December 2013 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Otitis media cases
|
Eligibility| Ages Eligible for Study: | 6 Weeks to 18 Years (Child, Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Children aged 6 weeks to 18 years
Criteria
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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272999
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272999
Locations
| 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 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01272999 History of Changes |
| Other Study ID Numbers: | 6096A1-4024 B1851040 |
| Study First Received: | December 8, 2010 |
| Last Updated: | September 10, 2014 |
| Health Authority: | United States: Institutional Review Board |
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 |
ClinicalTrials.gov processed this record on September 23, 2016