Flu Shot for Elderly Individuals

Overseen By Janna Shapiro

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Oral steroids, Immune modulators

Disqualifiers: Egg allergy, Active malignancies, Inflammatory diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

1025 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the immune systems of individuals over 75 respond to the flu shot (influenza vaccine) and whether chronic cytomegalovirus (CMV) affects this response. Participants will receive a flu shot and provide blood samples to measure immune reactions. The study is open to those over 75 without certain health issues, such as active cancer or severe lung or heart conditions, and who are not on specific medications. Participants will attend several appointments for health assessments and blood tests, with follow-up calls during flu season. As an unphased study, this research allows participants to contribute to scientific understanding of immune responses in older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking oral steroids or immune-modulating drugs.

Is there any evidence suggesting that the flu shot is safe for elderly individuals?

Research has shown that the flu vaccine is generally safe for older adults. Studies have found that the flu shot can lower the risk of hospital visits for heart issues and other serious health problems in this group. Many studies have examined the vaccine's safety, and most people experience only mild side effects, such as a sore arm or slight fever. High-dose flu vaccines, often given to seniors, boost the immune system without adding major risks. The flu shot is recommended annually for people over 50, indicating it is well-tolerated in this age group. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard flu vaccines that are typically administered to the elderly, this influenza immunization focuses specifically on adults over age 75. Researchers are excited because it may offer enhanced immune protection tailored to the unique needs of this age group, who often have weaker immune responses. By potentially improving the vaccine's effectiveness in older adults, it could significantly reduce flu-related complications and hospitalizations in this vulnerable population.

What evidence suggests that the flu shot is effective for elderly individuals over 75?

Research has shown that flu vaccines work well for older adults, including those over 75. Studies have found that these vaccines lower the chances of severe illness, hospitalization, or death from flu-related issues. For example, vaccines can reduce hospital visits for heart problems and pneumonia by about 27% in older people. Although older adults may not respond as strongly to the vaccine, it still offers important protection against the flu. High-dose vaccines provide even better protection for older adults than regular doses. This trial will focus on influenza immunization in adults over age 75. Vaccination is an important step to stay healthy during flu season. ^{1 4 6 7 8}

Who Is on the Research Team?

Sean Leng

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults over the age of 75, regardless of their health status. It's not suitable for those on cancer treatments, with egg or vaccine allergies, active cancers, inability to consent, acute heart/lung conditions exacerbations, or taking steroids/immune-modifying drugs.

Inclusion Criteria

I am over 75 years old.

Exclusion Criteria

I am currently undergoing radiation or chemotherapy.

I am currently taking oral steroids or drugs that affect my immune system.

You are allergic to eggs or vaccines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or at home)

Vaccination and Initial Monitoring

Participants receive the Influenza vaccine and initial monitoring including blood samples and surveys

4 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after vaccination, including weekly health calls and additional blood draws if symptoms occur

Flu season (up to 6 months)

Weekly calls, additional visits if symptoms occur

Long-term Surveillance

Annual assessment of vaccine effectiveness and chronic CMV infection impact over 4 years

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Influenza

Trial Overview The study tests how well people over 75 respond to the flu shot and if chronic CMV infection affects this response. Participants will receive a free flu shot and undergo health assessments including blood draws before and after vaccination.

How Is the Trial Designed?

Group I: Influenza Immunization Experimental Treatment 1 Intervention

Influenza immunization in adults over age 75

Influenza is already approved in United States, European Union for the following indications:

Approved in United States as Fluzone for:

• Prevention of influenza infections in individuals 6 months and older

Approved in United States as Fluad for:

• Prevention of influenza infections in individuals 65 years and older

Approved in United States as Flublok for:

• Prevention of influenza infections in individuals 18 years and older

Approved in United States as Flucelvax for:

• Prevention of influenza infections in individuals 6 months and older

Approved in United States as Afluria for:

• Prevention of influenza infections in individuals 6 months and older

Approved in United States as FluMist for:

• Prevention of influenza infections in individuals 2 through 49 years

Approved in European Union as Fluzone for:

• Prevention of influenza infections in individuals 6 months and older

Approved in European Union as Fluad for:

• Prevention of influenza infections in individuals 65 years and older

Approved in European Union as Flublok for:

• Prevention of influenza infections in individuals 18 years and older

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

In a review of 27 patients injured by less-lethal weapons during civil unrest, 28% experienced significant morbidity, highlighting the potential for serious injuries despite the non-lethal intent of these weapons.

Among the injuries documented, three patients required hospitalization for severe conditions, including pulmonary contusion and liver laceration, indicating that even less-lethal weapons can cause critical harm and necessitate medical awareness of possible complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injury patterns related to use of less-lethal weapons during a period of civil unrest. Suyama, J., Panagos, PD., Sztajnkrycer, MD., et al.[2019]

Fluzone High-Dose is an injectable influenza vaccine specifically designed for individuals aged 65 and older, containing a higher amount of hemagglutinin antigen to improve immune response compared to standard vaccines.

The FDA approved Fluzone High-Dose for this age group due to their increased risk of severe influenza outcomes, although the Advisory Committee on Immunization Practices did not express a preference for it over other vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Licensure of a high-dose inactivated influenza vaccine for persons aged >or=65 years (Fluzone High-Dose) and guidance for use - United States, 2010. [2017]

Fluad, an MF59-adjuvanted subunit influenza vaccine, is specifically designed to enhance immune responses in vulnerable populations, particularly the elderly, who may have weakened immune systems.

Clinical effectiveness data indicate that Fluad provides greater immunogenicity compared to conventional influenza vaccines, potentially offering better protection against the disease in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MF59-adjuvanted subunit influenza vaccine: an improved interpandemic influenza vaccine for vulnerable populations. Puig Barberà, J., González Vidal, D.[2013]

Approximately 26.7% of older adults (ages 50-80) in the U.S. own firearms, primarily for protection, but only 39.4% store them safely (unloaded and locked), highlighting a significant risk for injury mortality in this age group.

There is strong support among older firearm owners for policy interventions aimed at enhancing safety, such as comprehensive background checks and restricting access for individuals deemed a danger to themselves or others, indicating a potential pathway for improving firearm safety through healthcare and policy initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Firearm ownership, attitudes, and safe storage practices among a nationally representative sample of older U.S. adults age 50 to 80. Carter, PM., Losman, E., Roche, JS., et al.[2022]

An estimated 67,864 emergency department visits by elderly patients (≥ 65 years) for consumer product-related eye injuries occurred in the U.S. from 2001 to 2007, with a significant majority (64%) being male and 70% of incidents happening at home.

The most common causes of these injuries were chemicals (22%) and cutting tools/construction (21%), with a high proportion of preventable injuries associated with cutting tools (90%) and gardening (88%), indicating a need for improved safety measures in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye injuries in the elderly from consumer products in the United States: 2001-2007. Chen, AJ., Kim, JG., Linakis, JG., et al.[2021]

A qualitative study involving 17 male veterans aged 50-70 revealed that early firearm experiences, often facilitated by family, shape their beliefs about firearm safety and usage, highlighting the importance of social and familial contexts in firearm-related interventions.

Veterans expressed a strong belief in the need for firearm safety discussions, particularly emphasizing that not everyone should have access to firearms, which suggests that targeted interventions should consider their values and preferences for effective implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Firearm-related experiences and perceptions among United States male veterans: A qualitative interview study. Simonetti, JA., Dorsey Holliman, B., Holiday, R., et al.[2023]

A study of 2,152 US adult firearm owners found that older adults (≥65 years) prioritize speed and ease of access when selecting firearm locking devices, which are crucial for reducing the risk of suicide and injury.

Older males specifically prefer locking devices that allow firearms to remain loaded, indicating that their preferences may influence the effectiveness of firearm injury prevention strategies in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults' Preferences Regarding Firearm Locking Device Use: Results of a National Survey. Villarreal, RI., Stanley, IH., Anestis, MD., et al.[2023]

In a study involving 80 elderly volunteers, both the intramuscular MF59-adjuvanted vaccine (Fluad®) and the intradermal vaccine (Intanza®) effectively increased antibody responses against influenza strains A(H3N2) and A(H1N1) one month after vaccination.

The intradermal vaccine showed higher antibody responses against the B strain compared to the intramuscular vaccine, although both vaccines had lower responses against the B strain than the A strains. Both vaccines also provided positive responses against circulating drifted A(H3N2) viruses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibody responses to intradermal or intramuscular MF59-adjuvanted influenza vaccines as evaluated in elderly institutionalized volunteers during a season of partial mismatching between vaccine and circulating A(H3N2) strains. Camilloni, B., Basileo, M., Di Martino, A., et al.[2021]

In a clinical trial involving 2640 adults aged 50 and older, Flublok showed non-inferior safety compared to AFLURIA regarding hypersensitivity reactions, with only a slight difference in reported cases (0.15%).

Both vaccines had similar reactogenicity and overall adverse event profiles, indicating that Flublok is a safe alternative for seasonal influenza vaccination in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized comparison of the safety of Flublok(®) versus licensed inactivated influenza vaccine in healthy, medically stable adults ≥ 50 years of age. Izikson, R., Leffell, DJ., Bock, SA., et al.[2022]

The adjuvanted inactivated influenza vaccine quadrivalent (aIIV4) is specifically designed to enhance the immune response in older adults (65 years and older), who typically have a weaker response to standard influenza vaccines.

While aIIV4 is effective in protecting against influenza, it does carry a warning for potential Guillain-Barré syndrome and common side effects include injection site pain, fatigue, headache, and muscle aches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvanted inactivated influenza Vaccine Quadrivalent for Older People. Barranco, D., Chahine, EB.[2021]

Citations

1. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-10-20-05-00-00-3169062

Press Release: Sanofi's high-dose influenza vaccine ... Sanofi's high-dose influenza vaccine demonstrates superior protection for older adults against hospitalization vs standard-dose.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5812289/

Influenza Vaccine Effectiveness in Older Adults Compared ... There have been inconsistent reports of decreased vaccine effectiveness (VE) against influenza viruses among older adults (aged ≥65 years) compared with ...

3. cdc.gov cdc.gov/flu/highrisk/65over.htm

Flu and People 65 Years and Older | Influenza (Flu) Although immune responses to vaccination may be lower in older people, studies have consistently found that flu vaccination has been effective ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40955150/

High-dose influenza vaccine for elderly: a closer look into ... This review examined real-world effectiveness data comparing HD and SD influenza vaccines in elderly populations. While HD vaccines may ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1568163720302531

The efficacy and safety of influenza vaccination in older ... Vaccines decrease hospitalization for heart disease and for flu/ pneumonia by 27 %. •. Influenza vaccines in the elderly should be administered on the large ...

6. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-Flucelvax.pdf

Package Insert - Flucelvax In the safety population, 894 subjects (37.2%) were 6 months through 23 months of age, and 1508 subjects (62.8%) were 24 months through 47 months of age. The ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5861790/

Influenza vaccines: Evaluation of the safety profile - PMC The aim of this review is to provide an overview of influenza vaccine safety according to target groups, vaccine types and production methods.

8. goodrx.com goodrx.com/conditions/flu-vaccination/high-dose-flu-vaccine?srsltid=AfmBOootfhwbL4Ye8HNkXZR2dHohljo7kwfj-hVuQZfqIF-ciHqGKnM6

High-Dose Flu Shots for Seniors: What to Know Yes, evidence has shown that high-dose flu vaccines create a stronger immune response and are more effective than standard-dose vaccines for adults ages 65 and ...