Impact of Prevnar 13 on Ear Infections in Children

NCT01272999

Last updated date
Study Location
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Otitis Media, Mastoiditis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-18 weeks
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- As this is an observational, laboratory based database study, there are no exclusion
criteria

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Acute Otitis Media, MastoiditisImpact of Prevnar 13 on Ear Infections in Children NCT01272999
  1. Little Rock, Arkansas
  2. Los Angeles, California
  3. San Diego, California
  4. Chicago, Illinois
  5. Winston-Salem, North Carolina
  6. Columbus, Ohio
  7. Pittsburgh, Pennsylvania
  8. Houston, Texas
ALL GENDERS
6 Weeks+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Impact of Prevnar 13 on Ear Infections in Children
Official Title Postmarketing Observational Study Of The Impact Of Prevnar 13 (Pneumococcal 13 Valent Conjugate Vaccine) On Otitis Media In Children
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Microbiology samples (middle ear fluid) taken by treating physicians in standard course of care for ear infections.
Sampling Method Non-Probability Sample
Study Population Children aged 6 weeks to 18 years
Condition
  • Acute Otitis Media
  • Mastoiditis
Intervention Not Provided
Study Groups/Cohorts 1
Otitis media cases
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 28, 2014)
391
Original Estimated Enrollment
 (submitted: January 7, 2011)
0
Actual Study Completion Date December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study:All
Ages 6 Weeks to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01272999
Other Study ID Numbers 6096A1-4024
B1851040
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2014