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

NCT01128439

Last updated date
Study Location
Kaiser Permanente Vaccine Study Center
Oakland, California, 94612, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Invasive Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


None

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Advanced Information
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. 2020 May 16. pii: piaa035. doi: 10.1093/jpids/piaa035. [Epub ahead of print]

*   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 CenterPfizer
PRS Account Pfizer
Verification Date November 2018