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Virus Therapy

Flu mRNA_Ph1_1_YA for Flu

Phase 1 & 2
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female between 18 and 64 years of age or between 65 and 85 years of age at the time of the first study intervention administration
Females of childbearing potential who have practiced adequate contraception, have a negative pregnancy test, and agree to continue contraception for at least 1 month after completion of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 1, day 22, day 29, day 43, and day 203
Awards & highlights

Study Summary

This trial will test a new flu vaccine in healthy adults aged 18 to 85 to see how safe and effective it is.

Who is the study for?
This trial is for healthy adults aged 18 to 85 who want to help test a new vaccine against the H5N1 influenza virus. Specific details about who can join are not provided, but typically participants must meet certain health standards and not have conditions that would exclude them.Check my eligibility
What is being tested?
The study is testing different doses of an mRNA vaccine designed to protect against the H5N1 flu. Participants will receive one of several dose levels or a placebo, which does no harm but contains no active vaccine.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 feelings of being unwell such as fever or fatigue, and other immune responses that show your body is building protection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 85 years old.
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I am using effective birth control and agree to continue for 1 month after the study ends.
Select...
I cannot become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 1, day 22, day 29, day 43, and day 203
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1, day 22, day 29, day 43, and day 203 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants with AESIs [Phase 2 Part B]
Percentage of participants with MAAEs [Phase 2 Part B]
Percentage of participants with SAEs [Phase 2 Part B]
+17 more
Secondary outcome measures
GMI of anti-HI antibody titers [Phase 2 Part B]
GMT of Anti-HI antibody titers [Phase 2 Part B]
Geometric mean increase (GMI) of HA antibody titers [Phase 1 and Phase 2 Part A]
+9 more

Trial Design

42Treatment groups
Experimental Treatment
Placebo Group
Group I: Flu mRNA_Ph2_7_YA Part B (Scenario 2/Segment 2)Experimental Treatment1 Intervention
YA participants receive 1 dose of Flu Pandemic mRNA_ Dose level 7 in Phase 2 Part B, at Day 1.
Group II: Flu mRNA_Ph2_7_YA Part B (Scenario 2/Segment 1)Experimental Treatment1 Intervention
YA participants receive 1 dose of Flu Pandemic mRNA_ Dose level 7 during Phase 2 Part B, at Day 1.
Group III: Flu mRNA_Ph2_7_OA Part B (Scenario 2/Segment 2)Experimental Treatment1 Intervention
OA participants receive 1 dose of Flu Pandemic mRNA_ Dose level 7 in Phase 2 Part B, at Day 1.
Group IV: Flu mRNA_Ph2_7_OA Part B (Scenario 2/Segment 1)Experimental Treatment1 Intervention
OA participants receive 1 dose of Flu Pandemic mRNA_ Dose level 7 during Phase 2 Part B, at Day 1.
Group V: Flu mRNA_Ph2_6_YA Part B (Scenario 2/Segment 2)Experimental Treatment1 Intervention
YA participants receive 1 dose of Flu Pandemic mRNA_ Dose level 6 during Phase 2 Part B, at Day 1.
Group VI: Flu mRNA_Ph2_6_YA Part B (Scenario 2/Segment 1)Experimental Treatment1 Intervention
YA participants receive 1 dose of Flu Pandemic mRNA_ Dose level 6 during Phase 2 Part B, at Day 1.
Group VII: Flu mRNA_Ph2_6_OA Part B (Scenario 2/Segment 2)Experimental Treatment1 Intervention
OA participants receive 1 dose of Flu Pandemic mRNA_ Dose level 6 in Phase 2 Part B, at Day 1.
Group VIII: Flu mRNA_Ph2_6_OA Part B (Scenario 2/Segment 1)Experimental Treatment1 Intervention
OA participants receive 1 dose of Flu Pandemic mRNA_ Dose level 6 during Phase 2 Part B, at Day 1.
Group IX: Flu mRNA_Ph2_5_YA Part AExperimental Treatment1 Intervention
YA participants receive 2 doses of Flu Pandemic mRNA_Dose level 5 during Phase 2 Part A, at Day 1 and at Day 22.
Group X: Flu mRNA_Ph2_5_OA Part AExperimental Treatment1 Intervention
OA participants receive 2 doses of Flu Pandemic mRNA_Dose level 5 during Phase 2 Part A, at Day 1 and at Day 22.
Group XI: Flu mRNA_Ph2_4_YA Part AExperimental Treatment1 Intervention
YA participants receive 2 doses of Flu Pandemic mRNA_Dose level 4 during Phase 2 Part A, at Day 1 and at Day 22.
Group XII: Flu mRNA_Ph2_4_OA Part AExperimental Treatment1 Intervention
OA participants receive 2 doses of Flu Pandemic mRNA_Dose level 4 during Phase 2 Part A, at Day 1 and at Day 22.
Group XIII: Flu mRNA_Ph2_3_YA Part AExperimental Treatment1 Intervention
YA participants receive 2 doses of Flu Pandemic mRNA_Dose level 3 during Phase 2 Part A, at Day 1 and at Day 22.
Group XIV: Flu mRNA_Ph2_3_OA Part AExperimental Treatment1 Intervention
OA participants receive 2 doses of Flu Pandemic mRNA_Dose level 3 during Phase 2 Part A, at Day 1 and at Day 22.
Group XV: Flu mRNA_Ph2_2_YA Part B (Scenario 1)Experimental Treatment5 Interventions
YA participants receive 1 dose of Flu Pandemic mRNA at a selected dose level 2 from the 5 dose levels tested during Phase 2 Part A administered in Phase 2 Part B, at Day 1.
Group XVI: Flu mRNA_Ph2_2_YA Part AExperimental Treatment1 Intervention
YA participants receive 2 doses of Flu Pandemic mRNA_Dose level 2 during Phase 2 Part A, at Day 1 and at Day 22.
Group XVII: Flu mRNA_Ph2_2_OA Part B (Scenario 1)Experimental Treatment5 Interventions
OA participants receive 1 dose of Flu Pandemic mRNA at a selected dose level 2 from the 5 dose levels tested during Phase 2 Part A administered in Phase 2 Part B, at Day 1.
Group XVIII: Flu mRNA_Ph2_2_OA Part AExperimental Treatment1 Intervention
OA participants receive 2 doses of Flu Pandemic mRNA_Dose level 2 during Phase 2 Part A, at Day 1 and at Day 22.
Group XIX: Flu mRNA_Ph2_1_YA Part B (Scenario 1)Experimental Treatment5 Interventions
YA participants receive 1 dose of Flu Pandemic mRNA at a selected dose level 1 from the 5 dose levels tested during Phase 2 Part A administered in Phase 2 Part B, at Day 1.
Group XX: Flu mRNA_Ph2_1_YA Part AExperimental Treatment1 Intervention
YA participants receive 2 doses of Flu Pandemic mRNA_Dose level 1 during Phase 2 Part A, at Day 1 and at Day 22.
Group XXI: Flu mRNA_Ph2_1_OA Part B (Scenario 1)Experimental Treatment5 Interventions
OA participants receive 1 dose of Flu Pandemic mRNA at a selected dose level 1 from the 5 dose levels tested during Phase 2 Part A administered in Phase 2 Part B, at Day 1.
Group XXII: Flu mRNA_Ph2_1_OA Part AExperimental Treatment1 Intervention
OA participants receive 2 doses of Flu Pandemic mRNA_Dose level 1 during Phase 2 Part A, at Day 1 and at Day 22.
Group XXIII: Flu mRNA_Ph1_5_YAExperimental Treatment1 Intervention
YA participants receive 2 doses of Flu Pandemic mRNA_Dose level 5 during Phase 1, at Day 1 and at Day 22.
Group XXIV: Flu mRNA_Ph1_5_OAExperimental Treatment1 Intervention
OA participants receive 2 doses of Flu Pandemic mRNA_Dose level 5 during Phase 1, at Day 1 and at Day 22.
Group XXV: Flu mRNA_Ph1_4_YAExperimental Treatment1 Intervention
YA participants receive 2 doses of Flu Pandemic mRNA_Dose level 4 during Phase 1, at Day 1 and at Day 22.
Group XXVI: Flu mRNA_Ph1_4_OAExperimental Treatment1 Intervention
OA participants receive 2 doses of Flu Pandemic mRNA_Dose level 4 during Phase 1, at Day 1 and at Day 22.
Group XXVII: Flu mRNA_Ph1_3_YAExperimental Treatment1 Intervention
YA participants receive 2 doses of Flu Pandemic mRNA_Dose level 3 during Phase 1, at Day 1 and at Day 22.
Group XXVIII: Flu mRNA_Ph1_3_OAExperimental Treatment1 Intervention
OA participants receive 2 doses of Flu Pandemic mRNA_Dose level 3 during Phase 1, at Day 1 and at Day 22.
Group XXIX: Flu mRNA_Ph1_2_YAExperimental Treatment1 Intervention
YA participants receive 2 doses of Flu Pandemic mRNA_Dose level 2 during Phase 1, at Day 1 and at Day 22.
Group XXX: Flu mRNA_Ph1_2_OAExperimental Treatment1 Intervention
OA participants receive 2 doses of Flu Pandemic mRNA_Dose level 2 during Phase 1, at Day 1 and at Day 22.
Group XXXI: Flu mRNA_Ph1_1_YAExperimental Treatment1 Intervention
YA participants receive 2 doses of Flu Pandemic mRNA_Dose level 1 during Phase 1, at Day 1 and at Day 22.
Group XXXII: Flu mRNA_Ph1_1_OAExperimental Treatment1 Intervention
OA participants receive 2 doses of Flu Pandemic mRNA_Dose level 1 during Phase 1, at Day 1 and at Day 22.
Group XXXIII: Placebo_Ph2_YA Part APlacebo Group1 Intervention
YA participants receive 2 doses of Placebo during Phase 2 Part A, at Day 1 and at Day 22.
Group XXXIV: Placebo_Ph1_YAPlacebo Group1 Intervention
YA participants receive 2 doses of Placebo during Phase 1, at Day 1 and at Day 22.
Group XXXV: Placebo_Ph1_OAPlacebo Group1 Intervention
OA Adult participants receive 2 doses of Placebo during Phase 1, at Day 1 and at Day 22.
Group XXXVI: Placebo_Ph2_OA Part APlacebo Group1 Intervention
OA participants receive 2 doses of Placebo during Phase 2 Part A, at Day 1 and at Day 22.
Group XXXVII: Placebo_Ph2_YA Part B (Scenario 2/Segment 1)Placebo Group1 Intervention
YA participants receive 1 dose of Placebo during Phase 2 Part B, at Day 1.
Group XXXVIII: Placebo_Ph2_YA Part B (Scenario 1)Placebo Group1 Intervention
YA participants receive 1 dose of Placebo during Phase 2 Part B, at Day 1.
Group XXXIX: Placebo_Ph2_OA Part B (Scenario 2/Segment 1)Placebo Group1 Intervention
OA participants receive 1 dose of Placebo during Phase 2 Part B, at Day 1.
Group XL: Placebo_Ph2_OA Part B (Scenario 1)Placebo Group1 Intervention
OA participants receive 1 dose of Placebo during Phase 2 Part B, at Day 1.
Group XLI: Placebo_Ph2_YA Part B (Scenario 2/Segment 2)Placebo Group1 Intervention
YA participants receive 1 dose of Placebo in Phase 2 Part B, at Day 1.
Group XLII: Placebo_Ph2_OA Part B (Scenario 2/Segment 2)Placebo Group1 Intervention
OA participants receive 1 dose of Placebo in Phase 2 Part B, 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?

GlaxoSmithKlineLead Sponsor
4,758 Previous Clinical Trials
8,103,050 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals above the age of 25 eligible to participate in this medical study?

"This clinical investigation is seeking individuals over 18 years old but under the age of 85 to participate."

Answered by AI

At how many distinct sites is the management of this study taking place?

"Patients can currently enroll in this research at 21 different sites. These locations include Little Rock, Fort Collins, and Fort Myers among others. Opting for the nearest site is advisable to reduce travel requirements during your participation."

Answered by AI

Would it be possible for me to participate in this medical study?

"Potential participants must be diagnosed with influenza and fall between the age range of 18 to 85. The trial aims to recruit approximately 1080 individuals."

Answered by AI

What is the current number of individuals who are being enrolled in this clinical investigation?

"Indeed, the details on clinicaltrials.gov suggest that this research endeavor is actively seeking suitable participants. Initially shared on April 18th, 2024 and most recently updated on April 19th, 2024, the investigation aims to recruit a total of 1080 patients across twenty-one distinct sites."

Answered by AI

Is the recruitment phase for this medical study currently ongoing?

"According to the details provided on clinicaltrials.gov, this investigation is presently seeking volunteers. The trial was initially published on April 18th, 2024 and underwent its latest revision on April 19th, 2024."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults
2024. "A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06382311.
All > Pflugerville Tx > Greensboro
~720 spots leftby Aug 2024
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