Phase
Condition
N/ATreatment
Fluarix Tetra Vaccine
Clinical Study ID
Ages > 65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participants aged >= 65 years of age
Participants and/or legally acceptable representative (s) (LAR) who in the opinionof the Investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits
Written or witnessed/thumb printed informed consent obtained from the participantand/or participant's LAR(s) after the study has been explained according to thelocal authority requirements and prior to performance of any study-specificprocedure
Exclusion
Exclusion Criteria:
History of severe allergic reactions (e.g., anaphylaxis) to any component of thevaccine, including egg protein, or following a previous dose of any influenzavaccine.
Receipt of licensed vaccine, immune sera and/or any blood products, or aninvestigational trial agent within previous 30 days or planned during theirparticipation in the trial.
Receipt of any flu vaccine within 6 months before trial start or any other vaccinewithin 30 days before the trial.
Receipt of any dose of a Coronavirus Disease 2019 (COVID-19) vaccine within 15 daysof trial start.
History of Guillain-Barré Syndrome.
Altered immune status or chronic administration (defined as more than 14 days) ofimmunosuppressants or other immune-modifying agents within six months prior toadministration of trial vaccine.
History of acute infectious disease or acute respiratory illness needing antibioticsor antivirals in the previous 7 days, based on investigator's judgement.
If a participant candidate has fever, the trial vaccination should be postponed towhen the fever has resolved for at least 2 days (temporary exclusion criterion).Fever is defined as temperature >=38.0 degree Celsius (°C) (100.4 degrees Fahrenheit [°F]) by any route. The preferred location for measuring temperature will be oralroute.
Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renalfunctional abnormality, as determined by medical history, physical examination, orlaboratory screening tests.
Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the participant due to participation in the trial.
Study Design
Connect with a study center
GSK Investigational Site
Vishakhapatnam, Andhra Pradesh 530002
IndiaSite Not Available
GSK Investigational Site
Belagavi, 590010
IndiaSite Not Available
GSK Investigational Site
Kattankulathur, 603211
IndiaSite Not Available
GSK Investigational Site
Nashik, 422003
IndiaSite Not Available
GSK Investigational Site
Varanasi, 221010
IndiaSite Not Available
GSK Investigational Site
Vishakha Patnam, 530002
IndiaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.