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Impact of Prevnar 13 on Ear Infections in Children

This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01272999
First received: December 8, 2010
Last updated: June 14, 2013
Last verified: June 2013
History of Changes
  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 Phase
Acute Otitis Media
Mastoiditis
 Phase 4

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:

U.S. FDA Resources

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.


Estimated Enrollment: 0
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272999

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
United States, Arkansas
Arkansas Children's Hospital Not yet recruiting
Little Rock, Arkansas, United States, 72202
United States, California
Children's Hospital of Los Angeles - University of Southern California School of Medicine Not yet recruiting
Los Angeles, California, United States, 90027
Rady Children's Hospital - San Diego Not yet recruiting
San Diego, California, United States, 92123
United States, Illinois
Children's Memorial Hospital Not yet recruiting
Chicago, Illinois, United States, 60614
United States, North Carolina
Brenner Children's Hospital - Wake Forest University School of Medicine Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Nationwide Children's Hospital - Ohio State University of Medicine and Public Health Not yet recruiting
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Pittsburgh - University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Texas Children's Hospital - Feigin Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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: June 14, 2013
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
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013