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Virus Therapy
Universal Influenza Vaccine for Flu Prevention
Phase 1 & 2
Waitlist Available
Research Sponsored by Janssen Vaccines & Prevention B.V.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 8, 29, 57, 64, 85, 238 and 365
Awards & highlights
Study Summary
This trial evaluates the safety of a vaccine in adults 18-45 to help protect from flu.
Who is the study for?
Healthy adults aged 18-45 can join this trial. Women must use approved birth control and have negative pregnancy tests. Participants should not have had recent vaccines, investigational drugs/devices, or immune system issues. They also shouldn't be pregnant, breastfeeding, or planning to become pregnant soon.Check my eligibility
What is being tested?
The study is testing a new flu vaccine called INFLUENZA G1 mHA with or without an added ingredient (Al(OH)3 adjuvant). It's compared against a placebo to see how safe it is and how the body reacts to it in healthy adults.See study design
What are the potential side effects?
Possible side effects may include reactions at the injection site like pain and swelling, general symptoms such as fever or fatigue, allergic responses to vaccine components, and other potential immune-related effects.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 8, 29, 57, 64, 85, 238 and 365
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 8, 29, 57, 64, 85, 238 and 365
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of Solicited Local AEs at 7 Days Post-vaccination 1
Duration of Solicited Local AEs at 7 Days Post-vaccination 2
Duration of Solicited Systemic AEs at 7 Days Post-vaccination 1
+21 moreSecondary outcome measures
Quantification of Antibody Binding to Hemagglutinin (HA) Stem or Full-length Hemagglutinin as Assessed by Enzyme-linked Immunosorbent Assay (ELISA)
Trial Design
7Treatment groups
Experimental Treatment
Placebo Group
Group I: INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + PlaceboExperimental Treatment2 Interventions
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Day 1 and placebo on Day 57 in Cohort 2.
Group II: INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3Experimental Treatment2 Interventions
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Days 1 and 57 in Cohort 2.
Group III: INFLUENZA G1 mHA Dose Level 2 + PlaceboExperimental Treatment1 Intervention
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Day 1 and placebo on Day 57 in Cohort 2.
Group IV: INFLUENZA G1 mHA Dose Level 2Experimental Treatment1 Intervention
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Days 1 and 57 in Cohort 2.
Group V: INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3Experimental Treatment2 Interventions
Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 1 with Aluminum Hydroxide (Al[OH])3 adjuvant on Days 1 and 57 in Cohort 1.
Group VI: INFLUENZA G1 mHA Dose Level 1Experimental Treatment1 Intervention
Participants will receive single intramuscular (IM) injection of INFLUENZA G1 mHA Dose level 1 on Days 1 and 57 in Cohort 1.
Group VII: PlaceboPlacebo Group1 Intervention
Participants will receive IM injection of placebo on Days 1 and 57 in Cohorts 1 and 2.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,779 Total Patients Enrolled
Janssen Vaccines & Prevention B.V.Lead Sponsor
55 Previous Clinical Trials
1,134,178 Total Patients Enrolled
Biomedical Advanced Research and Development AuthorityFED
80 Previous Clinical Trials
909,225 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of severe nerve damage.I have received immunoglobulins or blood products recently.My immune system is not working properly due to certain health conditions or medications.You need to have normal results from medical tests to join the study. In some cases, a few abnormal results may be okay if the doctor says so.I have received or plan to receive vaccines within certain timeframes.I haven't had a fever or serious illness in the last 24 hours.You have participated in a study for a pandemic flu vaccine before.I am generally healthy as confirmed by recent medical exams.I have undergone the required pregnancy tests.
Research Study Groups:
This trial has the following groups:- Group 1: INFLUENZA G1 mHA Dose Level 2 + Placebo
- Group 2: INFLUENZA G1 mHA Dose Level 1
- Group 3: INFLUENZA G1 mHA Dose Level 2
- Group 4: INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3
- Group 5: Placebo
- Group 6: INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3
- Group 7: INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + Placebo
Awards:
This trial has 0 awards, including: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.
Are there any opportunities for qualified individuals to join this clinical experiment?
"Affirmative. The information on clinicaltrials.gov clearly states that this research trial, which was originally posted on May 17th 2023, is open for volunteers and currently seeks 170 individuals from 3 different medical centres."
Answered by AI
Is the inclusion criteria for this clinical trial extended to octogenarians?
"This clinical trial only considers individuals aged 18 to 45 for enrollment. For those younger than 18, there are 40 trials available and 76 if the individual is over 65 years old."
Answered by AI
Could I be accepted as a participant in this experiment?
"To be eligible for this trial, applicants should have immunity against flu and must fit within the specified age bracket of 18 to 45 years. The study is seeking 170 participants in total."
Answered by AI
What is the cap on enrollment for this research endeavor?
"Indeed, clinicaltrials.gov data affirms that this trial is presently seeking participants; the initial post was made on May 17th 2023 and the most recent update occurred June 5th 2023. 170 patients from 3 distinct locations are required to participate in order for the study to be considered complete."
Answered by AI
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