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Virus Therapy
Influenza Vaccine for Flu
Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception for 28 days prior to study intervention administration, has a negative pregnancy test on the day of study intervention administration, and has agreed to continue adequate contraception for at least 1 month after study intervention administration.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 62 and day 183
Awards & highlights
Study Summary
This trial is testing a new vaccine for safety and how well it works. It is for healthy adults ages 18-64 and 65+.
Who is the study for?
Healthy adults aged 18-45 or 60-80 can join this flu vaccine trial. They must be willing to follow the study rules, not pregnant, and agree to use contraception. People with a history of serious health issues like cancer, neurological disorders, immune conditions, or those who've recently received other vaccines or treatments are excluded.Check my eligibility
What is being tested?
The trial is testing different doses of GSK's new mRNA-based flu vaccine (GSK4382276A) in young and older adults. It aims to check how safe it is and how well it triggers an immune response against influenza.See study design
What are the potential side effects?
Possible side effects may include typical reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, allergic reactions to components in the vaccine, and potentially others that will be monitored during the trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 62 and day 183
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 62 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
Anti-vaccine antibody seroprotection rate (SPR)
Anti-vaccine antibody titers seroconversion rate (SCR)
GMT of anti-vaccine antibody titers
+8 moreSecondary outcome measures
Anti-vaccine antibody titer SPR
GMI of anti-vaccine antibody titer
GMT of anti-vaccine antibody titer.
Trial Design
14Treatment groups
Experimental Treatment
Active Control
Group I: YA GSK4382276A Dose level 9 GroupExperimental Treatment1 Intervention
Eligible YA participants receive dose level 9 of GSK4382276A study intervention administered at Day 1.
Group II: YA GSK4382276A Dose level 8 GroupExperimental Treatment1 Intervention
Eligible YA participants receive dose level 8 of GSK4382276A study intervention administered at Day 1.
Group III: YA GSK4382276A Dose level 7 GroupExperimental Treatment1 Intervention
Eligible YA participants receive dose level 7 of GSK4382276A study intervention administered at Day 1.
Group IV: YA GSK4382276A Dose level 6 GroupExperimental Treatment1 Intervention
Eligible YA participants receive dose level 6 of GSK4382276A study intervention administered at Day 1.
Group V: YA GSK4382276A Dose level 4 GroupExperimental Treatment1 Intervention
Eligible young adults (YA) participants receive dose level 4 of GSK4382276A study intervention administered at Day 1.
Group VI: YA GSK4382276A Dose level 3 GroupExperimental Treatment1 Intervention
Eligible young adults (YA) participants receive dose level 3 GSK4382276A study intervention administered at Day 1.
Group VII: YA GSK4382276A Dose level 2 GroupExperimental Treatment1 Intervention
Eligible young adults (YA) participants receive dose level 2 of GSK4382276A study intervention administered at Day 1.
Group VIII: YA GSK4382276A Dose level 11 GroupExperimental Treatment1 Intervention
Eligible YA participants receive dose level 11 of GSK4382276A study intervention administered at Day 1.
Group IX: YA GSK4382276A Dose level 10 GroupExperimental Treatment1 Intervention
Eligible YA participants receive dose level 10 of GSK4382276A study intervention administered at Day 1.
Group X: YA GSK4382276A Dose level 1 GroupExperimental Treatment1 Intervention
Eligible young adults (YA) participants receive dose level 1 of GSK4382276A study intervention administered at Day 1.
Group XI: OA GSK4382276A GroupExperimental Treatment3 Interventions
Eligible OA participants receive single dose of GSK4382276A study intervention at 1 dose level selected from the first 3 dose levels in YAs, administered at Day 1.
Group XII: OA Control GroupActive Control1 Intervention
Eligible OA participants receive single dose of FDQ21A-NH administered at Day 1.
Group XIII: YA Control 1 GroupActive Control1 Intervention
Eligible YA participants receive single dose of FDQ21A-NH administered at Day 1.
Group XIV: YA Control 2 GroupActive Control1 Intervention
Eligible YA participants receive single dose of FDQ22A-NH administered at Day 1.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
CureVac AGIndustry Sponsor
21 Previous Clinical Trials
44,230 Total Patients Enrolled
CureVacIndustry Sponsor
24 Previous Clinical Trials
46,177 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,148 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who cannot become pregnant.I am either 18-45 or 60-80 years old. If I'm older, I'm not over 70.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 don't have extensive tattoos on both arms that would affect skin assessments.I haven't received blood products or immunoglobulins in the last 90 days, except for COVID-19 treatment.I haven't taken long-acting immune drugs in the last 90 days and don't plan to during the study.I have had cancer before, but it has been completely resolved for over 5 years.I haven't received any vaccines not approved by the study within 4 weeks of starting or planned within 4 weeks after, except for COVID-19 vaccines.I do not have uncontrolled neurological disorders or seizures, except for childhood febrile seizures.I have a condition that weakens my immune system, like HIV.You have any important abnormality in your blood, clotting, or urine test results.I have had the flu shot within the last 6 months or plan to by Day 29.You have had a bad reaction to any part of the study treatment, including latex, poly-ethylene-glycol, egg protein, or aminoglycoside antibiotics.You have been around someone with the flu or confirmed COVID-19 in the past week and have not yet tested negative for COVID-19.I haven't taken immune system altering drugs, except for inhaled or topical steroids, in the last 3 months.You have a history of heavy drinking or drug use in the past 5 years.Your body mass index is between 18 and 32.I do not have significant lung, heart, liver, or kidney problems.
Research Study Groups:
This trial has the following groups:- Group 1: OA GSK4382276A Group
- Group 2: YA GSK4382276A Dose level 6 Group
- Group 3: OA Control Group
- Group 4: YA GSK4382276A Dose level 1 Group
- Group 5: YA GSK4382276A Dose level 3 Group
- Group 6: YA GSK4382276A Dose level 9 Group
- Group 7: YA GSK4382276A Dose level 10 Group
- Group 8: YA Control 1 Group
- Group 9: YA Control 2 Group
- Group 10: YA GSK4382276A Dose level 2 Group
- Group 11: YA GSK4382276A Dose level 4 Group
- Group 12: YA GSK4382276A Dose level 7 Group
- Group 13: YA GSK4382276A Dose level 8 Group
- Group 14: YA GSK4382276A Dose level 11 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What safety precautions are taken for patients prescribed YA GSK4382276A Dose level 2 Group?
"Due to the limited data associated with Phase 1 trials, YA GSK4382276A Dose level 2 Group was assigned a score of 1 for safety by Power's team."
Answered by AI
Are recruitment efforts still underway for this trial?
"Affirmative. Clinicaltrials.gov showcases that this trial, which was initially published on August 9th 2022, is actively enrolling participants. A total of 198 patients need to be recruited from 2 participating sites."
Answered by AI
What is the current population enrolled in this trial?
"Affirmative. Data hosted on clinicaltrials.gov demonstrates that this medical study, which was initially posted in August 9th 2022 is currently accepting applications. Approximately 198 participants need to be recruited from 2 distinct health institutions."
Answered by AI
Is the enrollment criterion for this trial limited to individuals aged eighteen and above?
"This medical trial welcomes patients of age 18 to 80. Of these individuals, 40 are minors and 70 are seniors."
Answered by AI
May I have the privilege to participate in this experiment?
"In order to qualify for this medical trial, prospective participants must have contracted the flu virus, be between 18 and 80 years old, and fill out an application. Currently there are 198 available spots in the research program."
Answered by AI
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