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

Pfizer

Status: Completed

Conditions: Adult Not Younger Than 65 Years

Study type: Observational

Funder types: Industry

Identifiers

NCT03014206

B1851121

Details and patient eligibility

About

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

Full 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.

Enrollment: 696 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design