Study Estimating the Impact of Prevnar 13™ (13vPnC) on Invasive Pneumococcal Disease
NCT01128439
Last updated date
ABOUT THIS STUDY
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.
Study Location
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
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
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 | 1 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria: None | |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | November 2018 | |||