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Impact of Prevnar 13 on Ear Infections in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01272999
First received: December 8, 2010
Last updated: September 10, 2014
Last verified: September 2014
  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
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

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:
No publications provided

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:
Mastoiditis
Otitis
Otitis Media
Bone Diseases
Bone Diseases, Infectious
Ear Diseases
Infection
Musculoskeletal Diseases
Osteomyelitis
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014