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Effect of Prevnar 13 on Ear Infections in Children

Last updated on November 13, 2019

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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.
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- 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.
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- 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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Descriptive Information
Brief TitleEffect of Prevnar 13 on Ear Infections in Children
Official Title"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
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 DescriptionInfants 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.
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenRetention:   Samples Without DNA
Description:
Middle Ear Fluid for microbiologic analysis Nose and throat swab for microbiologic analysis
Sampling MethodNon-Probability Sample
Study PopulationHealthy children aged approximately 6 to 36 months of age.
ConditionOtitis Media
Intervention
  • 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
Study Groups/Cohorts1
Interventions:
  • Procedure: Tympanocentesis
  • Procedure: Nose/throat swab
  • Biological: Observational
Publications *Pichichero M, Kaur R, Scott DA, Gruber WC, Trammel J, Almudevar A, Center KJ. Effectiveness of 13-valent pneumococcal conjugate vaccination for protection against acute otitis media caused by Streptococcus pneumoniae in healthy young children: a prospective observational study. Lancet Child Adolesc Health. 2018 Aug;2(8):561-568. doi: 10.1016/S2352-4642(18)30168-8. Epub 2018 Jun 19.


*   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: April 26, 2016)
239
Original Estimated Enrollment
 (submitted: September 9, 2010)
360
Actual Study Completion DateJanuary 2016
Actual Primary Completion DateJanuary 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages6 Months to 30 Months   (Child)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01199016
Other Study ID Numbers6096A1-4010
B1851018 ( Other Identifier: Alias Study Number )
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 DateDecember 2016

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