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

Last updated on December 2, 2019

FOR MORE INFORMATION
Study Location
Kaiser Permanente Vaccine Study Center
Oakland, California, 94612 United States
Contact
1-800-718-1021
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.
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- 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
NCT01128439
Pfizer
Completed
Study Estimating the Impact of Prevnar 13™ (13vPnC) on Invasive Pneumococcal Disease

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Descriptive Information
Brief TitleStudy Estimating the Impact of Prevnar 13? (13vPnC) on Invasive Pneumococcal Disease
Official TitleA 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 SummaryThis 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 DescriptionNo sampling as no subjects are enrolled
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationPrimary Care Clinic
ConditionInvasive Pneumococcal Disease
InterventionOther: No intervention
No intervention
Study Groups/Cohorts1
Intervention: Other: No intervention
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
 (submitted: November 10, 2014)
1
Original Estimated Enrollment
 (submitted: May 20, 2010)
0
Actual Study Completion DateApril 2015
Actual Primary Completion DateApril 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01128439
Other Study ID Numbers6096A1-4005
B1851042 ( Other Identifier: Alias Study Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsKaiser Permanente
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2018

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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