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Effect of Prevnar 13 on Ear Infections in Children

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Penfield Pediatrics
Penfield, New York, 14526 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Otitis Media
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-30 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subject has received full (3-dose) infant series of Prevnar 13

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

- Prior vaccination with any 7vPnC.

- Prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vPS).

- Any major illness/condition that, in the investigator's judgment, will substantially
increase the risk associated with the subject's participation in the study.

NCT01199016
Pfizer
Completed
Effect of Prevnar 13 on Ear Infections in Children

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Effect of Prevnar 13 on Ear Infections in Children
"a Phase 4, Postmarketing Study Evaluating The Impact Of Prevnar 13 (Trademark)(13-valent Pneumococcal Conjugate Vaccine; 13vpnc) In Reducing Acute Otitis Media And Nasopharyngeal Colonization Caused By Streptococcus Pneumoniae In Healthy 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.
Infants who have completed the Prevnar 13 infant vaccination series who provide consent and fit the study inclusion criteria to participate in the study will be recruited.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Middle Ear Fluid for microbiologic analysis Nose and throat swab for microbiologic analysis
Non-Probability Sample
Healthy children aged approximately 6 to 36 months of age.
Otitis Media
  • Procedure: Tympanocentesis
    To be performed as needed on children presenting with acute otitis media
  • Procedure: Nose/throat swab
    To be performed at every study visit
  • Biological: Observational
    Observational Study Only
1
Interventions:
  • Procedure: Tympanocentesis
  • Procedure: Nose/throat swab
  • Biological: Observational
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
239
January 2016
January 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has received full (3-dose) infant series of Prevnar 13

Exclusion Criteria:

  • Prior vaccination with any 7vPnC.
  • Prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vPS).
  • Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.
Sexes Eligible for Study: All
6 Months to 30 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01199016
6096A1-4010
B1851018 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2016

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.

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