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Impact of Prevnar 13 on Ear Infections in Children

Last updated on October 11, 2019

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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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Descriptive Information
Brief TitleImpact of Prevnar 13 on Ear Infections in Children
Official TitlePostmarketing Observational Study Of The Impact Of Prevnar 13 (Pneumococcal 13 Valent Conjugate Vaccine) On Otitis Media In Children
Brief SummaryPrevnar (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 DescriptionNot Provided
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   None Retained
Description:
Microbiology samples (middle ear fluid) taken by treating physicians in standard course of care for ear infections.
Sampling MethodNon-Probability Sample
Study PopulationChildren aged 6 weeks to 18 years
Condition
  • Acute Otitis Media
  • Mastoiditis
InterventionNot Provided
Study Groups/Cohorts1
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 StatusCompleted
Actual Enrollment
 (submitted: July 28, 2014)
391
Original Estimated Enrollment
 (submitted: January 7, 2011)
0
Actual Study Completion DateDecember 2013
Actual Primary Completion DateDecember 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
Ages6 Weeks to 18 Years   (Child, Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01272999
Other Study ID Numbers6096A1-4024
B1851040
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2014

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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