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

Completed

• Conditions: Adult Not Younger Than 65 Years

• Registration Number: NCT03014206
• Lead Sponsor: 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

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 Timeline

• Study Start: 2015-06-15
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-09
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Results First Submitted: 2018-01-30
• Results First Submitted QC: 2018-10-18
• Results First Posted: 2019-02-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-18
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 696

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Reactions	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.