Flu Vaccine for Flu
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new mRNA-based flu vaccines to assess their safety and effectiveness in boosting the immune system in healthy adults. Participants are divided into groups, with some receiving the new vaccine and others receiving standard flu vaccines for comparison. Individuals who are generally healthy or have stable chronic conditions, and have not recently received a flu vaccine or had a flu infection, may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to important vaccine development.
Do I have to stop taking my current medications to join the trial?
The trial does not specify that you need to stop taking your current medications, but it does exclude those on immune-modifying drugs or certain other treatments. It's best to discuss your specific medications with the trial investigator to see if they affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
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 no serious side effects. Similarly, other mRNA flu vaccines, such as mRNA-1020 and mRNA-1030, did not cause any deaths or serious health issues related to the vaccine over six months. These findings suggest that new mRNA flu vaccines, including the one in this study, are likely safe for participants.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about the Flu mRNA vaccines because they utilize mRNA technology, which is different from traditional flu vaccines that often use inactivated or weakened viruses. The mRNA approach instructs cells to produce a protein that triggers an immune response without using the virus itself. This method could potentially lead to faster and more adaptable vaccine production, offering better protection against emerging flu strains. Additionally, the study is exploring two formulations, A and B, to determine the most effective option for both younger and older adults.
What evidence suggests that this trial's treatments could be effective for flu?
Studies have shown that mRNA-based flu vaccines can strengthen the body's defense against the flu. In this trial, participants will receive different formulations of an mRNA flu vaccine. Previous findings suggest that these vaccines, like the ones being tested, provide a stronger immune response, especially against influenza A strains. Research indicates that these vaccines are over 50% effective in healthy people, offering strong protection. In some studies, similar mRNA flu vaccines lowered the risk of flu-related hospital visits by 35% in high-risk groups. This evidence supports the idea that these mRNA flu vaccines could effectively prevent the flu.35678
Are You a Good Fit for This Trial?
Adults at least 18 years old, with a BMI between 18 and 33, can join this flu vaccine study. They must be healthy or have stable chronic conditions without recent hospitalizations. Women must test negative for pregnancy and use contraception.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 assigned vaccine or comparator on Day 1
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and laboratory abnormalities
What Are the Treatments Tested in This Trial?
Interventions
- Flu mRNA Vaccine
Trial Overview
The trial is testing two mRNA-based flu vaccines against three comparators in adults to evaluate immune response and safety. Participants will receive one of the vaccines or a comparator product.
How Is the Trial Designed?
9
Treatment groups
Experimental Treatment
Active Control
Eligible YA participants receive a single dose of Flu mRNA Formulation B (GSK6479715A) as study intervention at Day 1.
Eligible OA participants receive a single dose of Flu mRNA Formulation B (GSK6479715A) as study intervention at Day 1.
Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1.
Eligible Older Adults (OA) participants receive a single dose of Flu mRNA Formulation A (GSK6479720A) as study intervention at Day 1.
Eligible OA participants receive a single dose of comparator 1 at Day 1.
Eligible OA participants receive a single dose of comparator 3 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 2 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
1.
cidrap.umn.edu
cidrap.umn.edu/influenza-vaccines/moderna-announces-promising-efficacy-results-mrna-flu-vaccine-trialModerna announces promising efficacy results ... - CIDRAP
In a press release, the company said its candidate flu vaccine, called mRNA 1010, showed superior results, with an rVE of 26.6% in the overall ...
An mRNA-based seasonal influenza vaccine in adults
The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains ...
Moderna reports positive phase 3 data for mRNA seasonal ...
Moderna this week announced positive data from a phase 3 trial of its messenger RNA vaccine against seasonal influenza.
Comparing Moderna's mRNA-1083 and Pfizer's dual- ...
Influenza vaccinations have an effectiveness rate of over 50% in healthy individuals, as seen in individuals over 50 years old. This may ...
NCT05540522 | A Study to Evaluate a Modified RNA ...
This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a quadrivalent influenza modRNA ...
FLULAVAL (Influenza Vaccine)
Safety data were obtained with FLULAVAL QUADRIVALENT in children aged 6 through 35 months. Data with FLULAVAL QUADRIVALENT are relevant to FLULAVAL because ...
Immunogenicity and safety of mRNA-based seasonal ...
Through 6 months, no deaths or serious adverse events were related to vaccination with mRNA-1020 or mRNA-1030 at any dose. These findings ...
8.
pfizer.com
pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-mrna-based-combinationPfizer and BioNTech Provide Update on mRNA-based ...
No safety signals with the combination vaccine have been identified in an ongoing safety data review. Participants who received a licensed ...
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