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Impact of Prevnar 13 on Ear Infections in Children

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Arkansas Children's Hospital
Little Rock, Arkansas, 72202 United States
Contact
1-800-718-1021
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

NCT01272999
Pfizer
Completed
Impact of Prevnar 13 on Ear Infections in Children

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Impact of Prevnar 13 on Ear Infections in Children
Postmarketing Observational Study Of The Impact Of Prevnar 13 (Pneumococcal 13 Valent Conjugate Vaccine) On Otitis Media In Children
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
Microbiology samples (middle ear fluid) taken by treating physicians in standard course of care for ear infections.
Non-Probability Sample
Children aged 6 weeks to 18 years
  • Acute Otitis Media
  • Mastoiditis
Not Provided
1
Otitis media cases
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
391
December 2013
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Weeks to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01272999
6096A1-4024
B1851040
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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