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

Last updated on December 6, 2018

FOR MORE INFORMATION
Study Location
Tokyo, , Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adult Not Younger Than 65 Years
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT03014206
Pfizer
Completed
Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-

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Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-
Prevenar (13v) Adult Special Investigation (Regulatory Post Marketing Commitment Plan)

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
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.
Observational [Patient Registry]
Observational Model: Case-Only
Time Perspective: Prospective
28 Days
Not Provided
Probability Sample
Geriatric patients vaccinated with this product (adult not younger than 65 years)
Adult Not Younger Than 65 Years
Not Provided
Not Provided
Not Provided
 
Completed
696
January 2017
January 2017   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT03014206
B1851121
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2017

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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