Seasonal Influenza Vaccines for Flu

This trial aims to study how different approved flu vaccines affect the immune response, focusing on how antibodies respond to the vaccines. It involves several vaccines, such as Fluzone (Influenza Virus Vaccine) and Fluad (Adjuvanted Quadrivalent Inactivated Influenza Vaccine), with participants grouped by age and vaccine type. Healthy adults who haven't had respiratory infections in the past month and have no known allergy to flu vaccines make good candidates. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand how it benefits more patients.

The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants with certain medical conditions and recent vaccinations, so it's best to discuss your specific situation with the trial team.

Research has shown that all the flu vaccines in this study—Fluzone, Fluzone High-Dose, Flucelvax, and Fluad—are safe, as they have already received FDA approval.

Fluzone and Fluzone High-Dose do not contain any live flu virus, so they cannot cause the flu. Some individuals might experience mild soreness or swelling at the injection site, but serious side effects are rare.

Flucelvax is also safe. In past studies, fewer than 1% of participants experienced serious side effects within a month of vaccination. Most people have only mild reactions, if any.

Fluad has been tested in over 10,000 adults aged 65 and older, demonstrating its safety and tolerability. Most side effects are mild and temporary, such as soreness at the injection site.

Researchers are excited about these influenza vaccines because each offers unique benefits for different age groups. Flucelvax stands out as it is produced using cell culture technology instead of the traditional egg-based methods, which may result in a more effective vaccine for those 18–50 years old. Fluzone High-Dose and Fluad are designed specifically for older adults (65–80 years old), providing a higher dose or an adjuvanted formulation, respectively, to boost immune response in this age group. Each of these vaccines targets the flu virus differently, helping to enhance protection and effectiveness across varying populations.

This trial will compare different influenza vaccines. Studies have shown that Fluzone High-Dose, one of the vaccines in this trial, is 24% more effective than regular flu shots at preventing the flu in adults aged 65 and older. Another vaccine in this trial, Flucelvax, a cell-based vaccine, significantly reduces doctor visits due to the flu compared to traditional egg-based vaccines. Research on Fluad, also part of this trial, includes an ingredient to boost the immune response and indicates it provides strong protection and lowers the risk of hospitalization in older adults. These vaccines are all FDA-approved and have proven effective in preventing the flu and related complications.⁶⁷⁸⁹¹⁰