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OpenTrials
Completed

NCT Number: NCT03014206

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

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

Completed

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Key information

Conditions

Adult Not Younger Than 65 Years

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Geriatric patients vaccinated with this product (adult not younger than 65 years)
  • 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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

PREVENAR13(REGISTRIED) SUSPENSION LIQUID FOR INJECTION DRUG USE INVESTIGATION - ADULTS AGED 65 YEARS OR OLDER

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 9, 2017
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.