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Study Estimating the Impact of Prevnar 13™ (13vPnC) on Invasive Pneumococcal Disease

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ClinicalTrials.gov Identifier: NCT01128439
Recruitment Status : Completed
First Posted : May 21, 2010
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date May 20, 2010
First Posted Date May 21, 2010
Last Update Posted Date December 4, 2018
Study Start Date July 2010
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 20, 2010)
Incidence of IPD in the NCKP healthcare system in children 6 weeks through 5 years of age (prior to the sixth birthday) during each of the 5 years following introduction of Prevnar 13. [ Time Frame: 5 years ]
Original Primary Outcome Measures
 (submitted: May 20, 2010)
NA - no intervention
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: May 20, 2010)
NA - no intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study Estimating the Impact of Prevnar 13™ (13vPnC) on Invasive Pneumococcal Disease
Official Title A Postmarketing Observational Study Estimating The Impact Of Prevnar 13 (Trade Mark) (13vpnc) On Invasive Pneumococcal Disease Caused By Vaccine Serotypes Of Streptococcus Pneumoniae After Introduction Into Routine Pediatric Use
Brief Summary This study will estimate the incidence of invasive pneumococcal disease in members of the Northern Kaiser Permanente healthcare system during each of the 5 following introduction of Prevnar 13.
Detailed Description No sampling as no subjects are enrolled
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary Care Clinic
Condition Invasive Pneumococcal Disease
Intervention Other: No intervention
No intervention
Study Groups/Cohorts 1
Intervention: Other: No intervention
Publications * Baxter R, Aukes L, Pelton SI, Yee A, Klein NP, Gruber WC, Scott DA, Center KJ. Impact of the 13-Valent Pneumococcal Conjugate Vaccine on Invasive Pneumococcal Disease After Introduction Into Routine Pediatric Use. J Pediatric Infect Dis Soc. 2021 Mar 26;10(2):141-150. doi: 10.1093/jpids/piaa035.

*   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: November 10, 2014)
1
Original Estimated Enrollment
 (submitted: May 20, 2010)
0
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Documented invasive pneumococcal disease (IPD), defined as recovery of an isolate of S pneumoniae from a normally sterile site in a member of the surveillance population.

Exclusion Criteria:

None

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
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 NCT01128439
Other Study ID Numbers 6096A1-4005
B1851042 ( 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 Kaiser Permanente
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018