A single-arm, open-label, multi-center, phase IV trial to evaluate the reactogenicity, safety, and immunogenicity of quadrivalent seasonal influenza vaccine (Fluarix Tetra) in participants aged 65 years and older in India
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 250
- Locations
- 7
- Primary Endpoint
- 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.
Study Overview
Brief Summary
| Overview of study design: A prospective, single-arm, open-label, multi-center, phase IV trial. |
Study sites: This trial will be conducted in multiple sites during northern hemisphere influenza season in India.
Vaccination schedule: A single 0.5 ml intramuscular dose of Fluarix Tetra will be administered.
Safety and reactogenicity monitoring:
· Recording of solicited adverse events (AEs) for 7 days (Day 1 to Day 7) after vaccination
· Recording of unsolicited AEs for 21 days (Day 1 to Day 21) after Fluarix Tetra is administered
· Recording of SAEs for 21 days (Day 1 to Day 21) after vaccination
Immunogenicity assessment:
· Blood Samples: Two 5 mL blood samples will be collected, one before administration of a single dose of study vaccine at Day 1 and one at Day 21.
· Laboratory testing: Serum HI antibodies will be measured against the four influenza strains that the Fluarix Tetra are designed to protect against. GMT, MGI, SCR and SPR shall be evaluated to assess immunogenicity.
Type of study vaccine intervention: Open label.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 65.00 Year(s) to 99.00 Year(s) (—)
- Sex
- All
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.
- •â€¢ 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).
- •â€¢ 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
- •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.
- •â€¢ 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.
- •â€¢ Receipt of any flu vaccine within 6 months before trial start or any other vaccine within 30 days before the trial.
- •â€¢ Receipt of any dose of a COVID-19 vaccine within 15 days of trial start.
- •â€¢ History of Guillain-Barré Syndrome.
- •â€¢ 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.
- •â€¢ History of acute infectious disease or acute respiratory illness needing antibiotics or antivirals in the previous 7 days, based on Investigator’s judgment.
- •â€¢ 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.
- •â€¢ Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by medical history, physical examination, or laboratory screening tests.
- •â€¢ Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the trial.
Outcomes
Primary Outcomes
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.
Time Frame: • 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 Outcomes
- To evaluate immunogenicity of Fluarix Tetra single dose 0.5 ml (I/M) in participants aged 65 years and above in India(• Geometric mean titers (GMT) of serum hemagglutination-inhibiting (HI) antibodies against the four influenza vaccine strains at baseline day 1 and 21)