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.
- 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.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 * | 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 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 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
