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Not Yet Recruiting NCT05648357

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

Conditions: Influenza, Human

Sex: All
Ages: 65 Years – N/A
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 250
Sponsor: GlaxoSmithKline

Summary

The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter [mL]) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.

Eligibility Criteria

Inclusion Criteria:Male or female participants aged >= 65 years who are eligible to receive Fluarix Tetra according to current Indian national CDC guideline for Flu vaccination and able to comply with trial procedures.Signed informed consent form obtained from the participant.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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05648357). StuddyBuddy aggregates publicly available trial information.