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Effect of Prevnar 13 on Ear Infections in Children

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ClinicalTrials.gov Identifier: NCT01199016
Recruitment Status : Completed
First Posted : September 10, 2010
Results First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 8, 2010
First Posted Date September 10, 2010
Results First Submitted Date January 10, 2017
Results First Posted Date March 1, 2017
Last Update Posted Date March 1, 2017
Study Start Date September 2010
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 10, 2017)
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.
Original Primary Outcome Measures
 (submitted: September 9, 2010)
Streptococcus Pneumoniae serotypes 1, 3, 5, 6A, 7F, and 19A isolated from middle ear fluid from children with acute otitis media. [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: September 9, 2010)
Streptococcus Pneumoniae serotypes 1, 3, 5, 6A, 7F, and 19A isolated the respiratory tract of children enrolled in this study. [ Time Frame: 5 years ]
Current Other Pre-specified Outcome Measures
 (submitted: January 10, 2017)
  • Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes 1, 3, 5, 6A, 7F, or 19A in Healthy Participants [ Time Frame: Baseline up to Month 36 ]
    Total percentage of NP/OP 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. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.
  • Percentage of Middle Ear Fluid (MEF) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 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 Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported.
  • Percentage of Nasopharyngeal/Oropharyngeal (NP/OP) Samples With Positive Results for Streptococcus Pneumoniae Serotypes Other Than 1, 3, 5, 6A, 7F, or 19A in Healthy Participants [ Time Frame: Baseline up to Month 36 ]
    Total percentage of MEF samples that were tested positive for Streptococcus pneumoniae serotypes other than those included in Prevnar 13 (1, 3, 5, 6A, 7F, or 19A) have been reported. NP/OP samples were collected from participants at all healthy visits as well as AOM visits.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effect 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 Summary 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Middle Ear Fluid for microbiologic analysis Nose and throat swab for microbiologic analysis
Sampling Method Non-Probability Sample
Study Population Healthy children aged approximately 6 to 36 months of age.
Condition Otitis 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/Cohorts 1
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 Status Completed
Actual Enrollment
 (submitted: April 26, 2016)
239
Original Estimated Enrollment
 (submitted: September 9, 2010)
360
Actual Study Completion Date January 2016
Actual Primary Completion Date January 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
Ages 6 Months to 30 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01199016
Other Study ID Numbers 6096A1-4010
B1851018 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2016