Flu Vaccine for Influenza
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new flu vaccine using mRNA technology to evaluate its safety and effectiveness in boosting the immune system of healthy adults. The trial compares different formulations of this vaccine with standard flu vaccines. It suits healthy adults or those with stable chronic conditions who have not recently received a flu shot or had a flu infection and are willing to receive an mRNA vaccine. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in flu prevention.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on immune-modifying drugs or certain investigational products, you may need to stop them before joining the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that mRNA-based flu vaccines, like the one in this study, are generally safe. Studies have found that most people tolerate these vaccines well. For instance, one study reported that serious side effects occurred in less than 1% of participants. Most side effects, such as soreness at the injection site or mild flu-like symptoms, were mild and temporary.
Regarding the specific vaccines in this trial, earlier research has shown promising safety results. The Flu mRNA Formulation B3 was part of a study where doctors found it safe, with no major safety concerns. Similarly, the Flu mRNA Formulation A has been tested in thousands of adults, showing good tolerance with minimal side effects.
These findings suggest that participants in the trial can expect the treatments to be safe, with any side effects likely being mild and short-lived.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these new flu vaccines because they employ mRNA technology, which is a game-changer in the world of vaccines. Unlike traditional flu vaccines that use inactivated viruses or viral proteins, these mRNA vaccines teach your cells to make a protein that triggers an immune response. This approach can potentially offer faster production times and a more precise immune response tailored to emerging flu strains. Additionally, the mRNA formulations being tested might provide broader protection, which could be more effective than current vaccines in preventing the flu.
What evidence suggests that this trial's treatments could be effective for influenza?
Research shows that mRNA flu vaccines, tested in this trial, hold promise in combating the flu. Studies have found these vaccines to be up to 34.5% more effective than traditional egg-based flu vaccines, potentially protecting more people from illness. They can also be produced more quickly, allowing for a better match to the flu strains each year. In past studies, 57 out of 9,225 people who received an mRNA vaccine contracted the flu, compared to 87 out of 9,251 who received a different vaccine. This evidence suggests that mRNA flu vaccines could offer a more effective way to prevent the flu.678910
Are You a Good Fit for This Trial?
Adults aged 18 and above, both healthy individuals and those with stable chronic conditions, can join this flu vaccine study. They must be able to follow the trial's procedures, use contraception effectively, and have a BMI between 18-33 kg/m2. Pregnant women or those planning pregnancy are excluded.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of the mRNA-based multivalent seasonal influenza vaccine or comparator on Day 1
Follow-up
Participants are monitored for safety and effectiveness, including adverse events and serious adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Flu mRNA
Trial Overview
The trial is testing different formulations of GSK's mRNA-based flu vaccines (Formulation A, B1, B3) against comparators in younger and older adults to evaluate immune response and safety.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Active Control
Eligible YA participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1.
Eligible YA participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1.
Eligible YA participants receive a single dose of Flu mRNA Formulation B3 (GSK6498032A) as study intervention at Day 1.
Eligible YA participants receive a single dose of Flu mRNA Formulation B3 (GSK6498032A) as study intervention at Day 1.
Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA Formulation B1 (GSK6498032A) as study intervention at Day 1.
Eligible Older Adults (OA) participants receive a single dose of Flu mRNA Formulation B1 (GSK6498032A) as study intervention at Day 1.
Eligible OA participants receive a single dose of comparator 1 at Day 1.
Eligible YA participants receive a single dose of comparator 1 at Day 1.
Eligible YA participants receive a single dose of comparator 2 at Day 1.
Eligible OA participants receive a single dose of comparator 3 at Day 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School
Citations
Efficacy, Immunogenicity, and Safety of Modified mRNA ...
During the 2022–2023 influenza season, U.S.-licensed influenza vaccines had a vaccine effectiveness of approximately 44 to 54% in participants ...
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cidrap.umn.edu
cidrap.umn.edu/influenza-vaccines/experimental-mrna-flu-vaccine-shows-superior-efficacy-against-symptomaticExperimental mRNA flu vaccine shows superior efficacy ...
mRNA vaccines are more effective than egg-based vaccines and can be made more quickly, increasing the likelihood that they match circulating flu ...
Pfizer's mRNA flu vaccine shows 34.5% greater efficacy ...
Of 9,225 people received given Pfizer's mRNA vaccine, 57 developed the flu, compared to 87 of the 9,251 people given Sanofi's Fluzone shot.
Updated Evidence for Covid-19, RSV, and Influenza ...
Among immunocompromised adults, one multicenter U.S. case–control study showed an influenza vaccine effectiveness of 32% (95% CI, 7 to 50) ...
mRNA flu vaccine is up to 34.5% more effective ... - Scimex
An mRNA based flu vaccine, which has been developed by Pfizer, is 34.5% more effective against influenza-like illness compared to current flu ...
NCT07204964 | A Study to Evaluate the Immune ...
The purpose of this study is to assess the reactogenicity, safety and immune response of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based ...
Immunogenicity and safety of mRNA-based seasonal ...
Any solicited AR, reflective of reactogenicity, within 7 days of vaccination was reported by 93.3% of mRNA-1020 recipients (any dose), 90.2% of ...
An mRNA-based seasonal influenza vaccine in adults
... data (solicited safety ... In both trials, the original formulation of mRNA-1010 showed an acceptable safety profile in adult participants.
Flu Vaccine for Flu · Info for Participants
Research has shown that mRNA-based flu vaccines are generally safe and well-tolerated. In studies involving over 14,000 adults, the mRNA-1010 flu vaccine showed ...
Safety and immunogenicity of mRNA-based seasonal ...
Frequencies of solicited adverse reactions were similar across vaccine groups; 551 (79%) of 694 participants reported at least one solicited ...
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