Effect of Prevnar 13 on Ear Infections in Children

Overview

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.

Full Title of Study: “”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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2016

Detailed Description

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 1

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Participants With Acute Otitis Media (AOM)
    • Time Frame: Baseline up to Month 36
    • MEF samples were obtained from participants who presented with an episode of AOM as defined by clinical criteria. Total percentage of MEF samples that were tested positive for any of the 6 additional serotypes included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 30 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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