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Trial record 1 of 1 for:    NCT03014206
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Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-

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ClinicalTrials.gov Identifier: NCT03014206
Recruitment Status : Completed
First Posted : January 9, 2017
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date July 18, 2016
First Posted Date January 9, 2017
Results First Submitted Date January 30, 2018
Results First Posted Date February 28, 2019
Last Update Posted Date February 28, 2019
Actual Study Start Date June 2015
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 18, 2018)
Number of Participants With Adverse Reactions [ Time Frame: 28 days ]
An adverse reaction (vaccine-related adverse event) was any untoward medical occurrence attributed to Prevenar 13 in a participant who received Prevenar 13. A serious adverse reaction was a vaccine-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Prevenar 13 was assessed by the physician.
Original Primary Outcome Measures
 (submitted: January 5, 2017)
Number of Subjects reporting Adverse Events [ Time Frame: 28 days ]
Change History Complete list of historical versions of study NCT03014206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-
Official Title Prevenar13(Registried) Suspension Liquid For Injection Drug Use Investigation - Adults Aged 65 Years Or Older
Brief Summary

This study aims to understand the following items in post-marketing actual clinical settings to evaluate the safety of 13vPnC administered as a single dose in the elderly (adults aged 65 years or older).

  1. To confirm the use in actual clinical settings
  2. To confirm the occurrence of adverse events
Detailed Description This study is a multicenter open-label cohort conducted in patients vaccinated with the Product; for which, case report forms will be recorded based on data presented in medical records obtained from day-to-day clinical treatment and diagnosis. "Pneumococcal vaccine health study diary" will be implemented to collect accurate safety data; to which, vaccine recipients will be asked directly to cooperate.
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration 28 Days
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Geriatric patients vaccinated with this product (adult not younger than 65 years)
Condition Adult Not Younger Than 65 Years
Intervention Not Provided
Study Groups/Cohorts Not Provided
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
 (submitted: February 16, 2017)
696
Original Estimated Enrollment
 (submitted: January 5, 2017)
660
Actual Study Completion Date January 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Geriatric patients vaccinated with this product (adult not younger than 65 years)
  2. Consent of vaccine recipients [Vaccine recipient (or his/her legally acceptable representative) must sign and date the consent form warranting that the relevant information concerning this Study was appropriately communicated to the recipient].

Exclusion Criteria:

None

Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03014206
Other Study ID Numbers B1851121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date October 2018