Your session is about to expire
← Back to Search
Cancer Vaccine
mRNA Flu Vaccine for Influenza
Phase 1 & 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 92 and day 183
Awards & highlights
Study Summary
This trial tests a new mRNA-based vaccine to see if it's safe and effective in young and older adults.
Who is the study for?
Healthy adults or those with stable chronic conditions, aged 18-50 in Phase 1 and 18-85 in Phase 2. Participants must have a BMI of >=18 and <=35 kg/m^2, agree to contraception if applicable, and not plan pregnancy soon after the trial. Exclusions include recent blood product receipt, influenza vaccination within past six months, other clinical trials participation, certain neurological disorders like Guillain-Barré syndrome, myocarditis/pericarditis history within ten years (including post-mRNA COVID-19 vaccine), dementia or severe cognitive impairment.Check my eligibility
What is being tested?
The study is testing GSK's mRNA-based multivalent seasonal flu vaccine candidates for safety and immune response in two age groups. It involves comparing the new vaccines against controls that may be placebos or standard treatments to determine their effectiveness.See study design
What are the potential side effects?
Potential side effects could include typical reactions at the injection site such as pain or swelling, general symptoms like fever or fatigue, allergic responses to components of the vaccine (e.g., polyethylene glycol), muscle aches, headaches and possibly more serious events related to immune system activation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 92 and day 183
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 92 and day 183
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Geometric mean increase (GMI) of antigen 1 antibody titer
Geometric mean titer (GMT) of antigen 1 antibody titer
Percentage of participants reporting a shift from a non-clinically significant laboratory value on Day 1 (pre-dose) to a clinically significant abnormal laboratory value on Day 8 (post-dose) and/or Day 29 (post-dose) for hematology and clinical chemistry
+8 moreSecondary outcome measures
GMI of antigen 1 antibody titer
GMI of antigen 2 antibody titer
GMT of antigen 1 antibody titer
+2 moreTrial Design
21Treatment groups
Experimental Treatment
Active Control
Group I: Flu mRNA_Ph2_3_YA GroupExperimental Treatment1 Intervention
Eligible YA participants receive single dose of Flu mRNA (GSK4382276A) study intervention formulation 3 administered in Phase 2, at Day 1.
Group II: Flu mRNA_Ph2_3_OA GroupExperimental Treatment1 Intervention
Eligible OA participants receive single dose of Flu mRNA (GSK4382276A) study intervention formulation 6 administered in Phase 2, at Day 1.
Group III: Flu mRNA_Ph2_2_YA GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 2 administered in Phase 2, at Day 1.
Group IV: Flu mRNA_Ph2_2_OA GroupExperimental Treatment1 Intervention
Eligible OA participants receive single dose of Flu mRNA (GSK4382276A) study intervention formulation 5 administered in Phase 2, at Day 1.
Group V: Flu mRNA_Ph2_1_YA GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 1 administered in Phase 2, at Day 1.
Group VI: Flu mRNA_Ph2_1_OA GroupExperimental Treatment1 Intervention
Eligible OA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 4 administered in Phase 2, at Day 1.
Group VII: Flu mRNA_1_9 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 9 administered in Phase 1, at Day 1.
Group VIII: Flu mRNA_1_8 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 8 administered in Phase 1, at Day 1.
Group IX: Flu mRNA_1_7 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 7 administered in Phase 1, at Day 1.
Group X: Flu mRNA_1_6 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 6 administered in Phase 1, at Day 1.
Group XI: Flu mRNA_1_5 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 5 administered in Phase 1, at Day 1.
Group XII: Flu mRNA_1_4 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 4 administered in Phase 1, at Day 1.
Group XIII: Flu mRNA_1_3 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 3 administered in Phase 1, at Day 1.
Group XIV: Flu mRNA_1_2 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 2 administered in Phase 1, at Day 1.
Group XV: Flu mRNA_1_12 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 12 administered in Phase 1, at Day 1.
Group XVI: Flu mRNA_1_11 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 11 administered in Phase 1, at Day 1.
Group XVII: Flu mRNA_1_10 GroupExperimental Treatment1 Intervention
Eligible YA participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 10 administered in Phase 1, at Day 1.
Group XVIII: Flu mRNA_1_1 GroupExperimental Treatment1 Intervention
Eligible Younger Adults (YA) participants receive a single dose of Flu mRNA (GSK4382276A) study intervention formulation 1 administered in Phase 1, at Day 1.
Group XIX: Control_Ph2_OA GroupActive Control1 Intervention
Eligible OA participants receive a single dose of Control 2 vaccine administered in Phase 2, at Day 1.
Group XX: Control GroupActive Control1 Intervention
Eligible YA participants receive a single dose of Control 1 administered in Phase 1, at Day 1.
Group XXI: Control_Ph2_YA GroupActive Control1 Intervention
Eligible YA participants receive single dose of Control 1 vaccine administered in Phase 2, at Day 1.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
CureVacIndustry Sponsor
24 Previous Clinical Trials
45,245 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,750 Previous Clinical Trials
8,066,196 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,142,674 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't received blood products or immunoglobulins in the last 90 days, except for COVID-19 treatment.You have a weakened immune system due to a medical condition, unless you have HIV and meet specific stable treatment requirements.I am a woman who can have children, have used birth control for 28 days, tested negative for pregnancy, and will continue birth control for 1 month after treatment.I have a condition that affects my thinking or memory.I have not received and do not plan to receive any vaccines outside the study's schedule around the time of the treatment.I don't have extensive tattoos on both arms that would affect skin assessments.I am a woman who cannot become pregnant.I haven't had a flu shot in the last 6 months and won't get one within 4 weeks after joining the study.I do not have uncontrolled neurological disorders or seizures, except for childhood febrile seizures.I have had heart inflammation within the last 10 years, including after a COVID-19 vaccine.I haven't taken long-acting immune drugs in the last 90 days and don't plan to during the study.I haven't taken long-term immune system drugs or high-dose steroids recently.You tested positive for the flu within the last 180 days before the study starts.I am bedridden.You have had a severe allergic reaction to a vaccine or any of the ingredients in the study treatment.In phase 1, you have any important abnormality in your blood, urine, or other lab tests that could affect your health.Your body mass index (BMI) is between 18 and 35.I am between 18 and 50 years old for Phase 1, or between 18 and 85 for Phase 2.You have had problems with alcohol or drugs in the past 2 years, like using too much, having issues with friends or family because of it, or feeling sick when not using.I have been cancer-free for more than 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Control_Ph2_OA Group
- Group 2: Flu mRNA_1_2 Group
- Group 3: Flu mRNA_1_1 Group
- Group 4: Flu mRNA_1_7 Group
- Group 5: Flu mRNA_1_3 Group
- Group 6: Flu mRNA_1_8 Group
- Group 7: Flu mRNA_1_4 Group
- Group 8: Flu mRNA_1_5 Group
- Group 9: Flu mRNA_1_6 Group
- Group 10: Flu mRNA_1_9 Group
- Group 11: Flu mRNA_1_10 Group
- Group 12: Flu mRNA_1_11 Group
- Group 13: Flu mRNA_1_12 Group
- Group 14: Flu mRNA_Ph2_1_YA Group
- Group 15: Control Group
- Group 16: Flu mRNA_Ph2_2_YA Group
- Group 17: Control_Ph2_YA Group
- Group 18: Flu mRNA_Ph2_3_YA Group
- Group 19: Flu mRNA_Ph2_1_OA Group
- Group 20: Flu mRNA_Ph2_2_OA Group
- Group 21: Flu mRNA_Ph2_3_OA Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Flu Patient Testimony for trial: Trial Name: NCT05823974 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who qualifies for inclusion in this clinical experiment?
"Potential candidates for this medical trial must have contracted the flu and be between 18-85 years old. Approximately 1512 people are needed to participate."
Answered by AI
Is this clinical trial accommodating participants aged fifty and over?
"As per the study's entrance criteria, those wishing to take part must be aged between 18 and 85. The research has earmarked 40 positions for minors and 75 spots are available for seniors."
Answered by AI
How many people have registered for this experiment?
"Affirmative. Clinicaltrials.gov officially records that this research project, which was initially published on April 27th 2023, is still looking for participants. A total of 1,512 volunteers across 5 different trial sites are required to complete the study."
Answered by AI
Are there any vacancies remaining in this research trial?
"Affirmative. The data hosted on clinicaltrials.gov reveals that this medical research, which was debuted on April 27th 2023, is currently searching for volunteers to join the trial. Specifically, 1512 participants are needed from 5 distinct locations."
Answered by AI
How widely is this medical experiment being conducted in Canadian healthcare facilities?
"Presently, the trial is accessible at 5 locations; Lexington, Fort Worth and Newport News are amongst these. To reduce travel needs for participants, it can be beneficial to select a nearby location."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I believe the mRNA technology is a very effective and safe method for helping people stay healthy. I am eager to help in the process of creating safe vaccines.
PatientReceived 1 prior treatment
I typically respond as expected to medication & feel that makes me a good research subject for new vaccines. I was contacted for this and other research opportunities v.i.a. email.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How long do trial visit last?
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger