Prevenar13 Drug Use Investigation - Adults Aged 65 Years or Older-
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|ClinicalTrials.gov Identifier: NCT03014206|
Recruitment Status : Completed
First Posted : January 9, 2017
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
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).
- To confirm the use in actual clinical settings
- To confirm the occurrence of adverse events
|Condition or disease|
|Adult Not Younger Than 65 Years|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||696 participants|
|Target Follow-Up Duration:||28 Days|
|Official Title:||Prevenar13(Registried) Suspension Liquid For Injection Drug Use Investigation - Adults Aged 65 Years Or Older|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||January 2017|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014206
|Study Director:||Pfizer CT.gov Call Center||Pfizer|