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Trial record 1 of 1 for:    NCT01128439
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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

Study Description
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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.

Condition or disease Intervention/treatment
Invasive Pneumococcal Disease Other: No intervention

Detailed Description:
No sampling as no subjects are enrolled
Study Design
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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : July 2010
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
1 Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinic
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128439


Locations
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United States, California
Kaiser Permanente Vaccine Study Center
Oakland, California, United States, 94612
Sponsors and Collaborators
Pfizer
Kaiser Permanente
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01128439    
Other Study ID Numbers: 6096A1-4005
B1851042 ( Other Identifier: Alias Study Number )
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: November 2018
Keywords provided by Pfizer:
Pneumococcal conjugate vaccine
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections