A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India
Launched by GLAXOSMITHKLINE · Dec 5, 2022
Trial Information
Current as of January 16, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male or female participants aged \>= 65 years of age
- • Participants and/or legally acceptable representative (s) (LAR) who in the opinion of 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 participant and/or participant's LAR(s) after the study has been explained according to the local authority requirements and prior to performance of any study-specific procedure
- Exclusion Criteria:
- • History of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine.
- • Receipt of licensed vaccine, immune sera and/or any blood products, or an investigational trial agent within previous 30 days or planned during their participation in the trial.
- • Receipt of any flu vaccine within 6 months before trial start or any other vaccine within 30 days before the trial.
- • Receipt of any dose of a Coronavirus Disease 2019 (COVID-19) vaccine within 15 days of trial start.
- • History of Guillain-Barré Syndrome.
- • Altered immune status or chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within six months prior to administration of trial vaccine.
- • History of acute infectious disease or acute respiratory illness needing antibiotics or antivirals in the previous 7 days, based on investigator's judgement.
- • If a participant candidate has fever, the trial vaccination should be postponed to when 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 oral route.
- • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination, or laboratory screening tests.
- • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the trial.
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Belagavi, , India
Vishakhapatnam, Andhra Pradesh, India
Nashik, Maharashtra, India
Kattankulathur, Tamil Nadu, India
Varanasi, Uttar Pradesh, India
Belagavi, Karnataka, India
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0
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