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

Adult Not Younger Than 65 Years Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03014206
• Other study ID #: B1851121
• Status: Completed
• Start date: June 15, 2015
• Est. completion date: January 31, 2017

Study information

• Verified date: August 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 696
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Not Younger Than 65 Years

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Reactions	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.	28 days

External Links

•   To obtain contact information for a study center near you, click here.