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Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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

Condition or disease
Adult Not Younger Than 65 Years

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 696 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 28 Days
Official Title: Prevenar13(Registried) Suspension Liquid For Injection Drug Use Investigation - Adults Aged 65 Years Or Older
Actual Study Start Date : June 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Geriatric patients vaccinated with this product (adult not younger than 65 years)
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014206


Locations
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Japan
Tokyo, Japan
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Statistical Analysis Plan  [PDF] December 8, 2016
Study Protocol  [PDF] July 22, 2016

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03014206    
Other Study ID Numbers: B1851121
First Posted: January 9, 2017    Key Record Dates
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019
Last Verified: October 2018