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

• ClinicalTrials.gov Identifier: NCT01128439
• Recruitment Status: Completed
• First Posted: May 21, 2010
• Last Update Posted: December 4, 2018
• Sponsor: Pfizer
• Collaborator: Kaiser Permanente
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: May 20, 2010
• First Posted Date: May 21, 2010
• Last Update Posted Date: December 4, 2018
• Study Start Date: July 2010
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 20, 2010): 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 ]
• Original Primary Outcome Measures (submitted: May 20, 2010): NA - no intervention
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: May 20, 2010): NA - no intervention
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

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]

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

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 Center; Pfizer

• PRS Account: Pfizer
• Verification Date: November 2018