Health Condition 1: J111- Influenza due to unidentified influenza virus with other respiratory manifestations
Conditions
Interventions
Intervention1: Fluarix Tetra: Frequency: single 0.5 ml
Route of administration: intramuscular
Total duration of intervention: A single 0.5 ml intramuscular dose of Fluarix Tetra will be administered.
Sponsors
GlaxoSmithKline Biologicals SA
IQVIA RDS INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the trial. Therefore, adherence to the criteria as specified in the protocol is essential. The following criteria must be met in order to be enrolled in the trial: • 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
Exclusion criteria: Deviations from the exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the trial. Therefore, adherence to the criteria as specified in the protocol is essential. Participants meeting ANY of the following criteria are not eligible for participation: 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 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 6 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 judgment. • 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°C (100.4°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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate reactogenicity and safety of Fluarix Tetra single dose 0.5 ml intramuscularly (I/M) in participants aged 65 years and above in India.Timepoint: • Number and percentage of subjects with solicited adverse events (AEs) (local as well as general) for 7 days from the date of vaccination (Day 1) • Number and percentage of subjects with unsolicited AEs starting from the date of vaccination for 21 days. • Number and percentage of subjects with serious adverse events (SAEs) from the date of vaccination for 21 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate immunogenicity of Fluarix Tetra single dose 0.5 ml (I/M) in participants aged 65 years and above in IndiaTimepoint: • Geometric mean titers (GMT) of serum hemagglutination-inhibiting (HI) antibodies against the four influenza vaccine strains at baseline day 1 and 21 • Mean geometric increase at Day 21. MGI is fold increase in post-vaccination serum HI GMTs (Day 21) compared to Day 1 • Seroconversion rate at Day 21. • Seroprotection rate at Day 1 and Day 21. SPR is defined as the percentage of subjects with a serum HI titer = 1:40. | — |
Countries
India
Contacts
Public ContactJinu Jose
IQVIA RDS (India) Private Limited
Outcome results
None listed