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YA GSK4382276A Dose level 2 Group for Flu

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
FluGSK4382276A Dose level 4 - Biological
Eligibility
18 - 80
All Sexes
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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+.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
qIRV
1
BPL-1357
1
Dose 2 of BMN 331

Study Objectives

11 Primary · 3 Secondary · Reporting Duration: At Day 62 and Day 183

At Day 1
Geometric mean titers (GMT) of anti-vaccine antibody titers
At Day 22
Anti-vaccine antibody seroprotection rate (SPR)
GMT of anti-vaccine antibody titers
Day 183
Anti-vaccine antibody titer SPR
GMT of anti-vaccine antibody titer.
Day 29
Number of participants reporting a shift from non-clinically significant laboratory value on Day 1 to clinically significant abnormal laboratory value on Day 8 or on Day 29 for hematology, clinical chemistry, coagulation and urine analysis
Day 183
GMI of anti-vaccine antibody titer
Number of participants reporting adverse events of special interest (AESIs)
Number of participants reporting serious adverse events (SAEs)
Day 22
Anti-vaccine antibody titers seroconversion rate (SCR)
Geometric mean increase (GMI) of anti-vaccine antibody titers
Day 28
Number of participants reporting unsolicited adverse events (AEs)
Day 7
Number of participants reporting each solicited administration site event
Number of participants reporting each solicited systemic event

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
qIRV
1
BPL-1357
1
Dose 2 of BMN 331

Trial Design

7 Treatment Groups

YA Control Group
1 of 7
OA Control Group
1 of 7
YA GSK4382276A Dose level 2 Group
1 of 7
YA GSK4382276A Dose level 3 Group
1 of 7
YA GSK4382276A Dose level 4 Group
1 of 7
YA GSK4382276A Dose level 1 Group
1 of 7
OA GSK4382276A Group
1 of 7

Active Control

Experimental Treatment

198 Total Participants · 7 Treatment Groups

Primary Treatment: YA GSK4382276A Dose level 2 Group · No Placebo Group · Phase 1

YA GSK4382276A Dose level 2 Group
Biological
Experimental Group · 1 Intervention: GSK4382276A Dose level 2 · Intervention Types: Biological
YA GSK4382276A Dose level 3 Group
Biological
Experimental Group · 1 Intervention: GSK4382276A Dose level 3 · Intervention Types: Biological
YA GSK4382276A Dose level 4 Group
Biological
Experimental Group · 1 Intervention: GSK4382276A Dose level 4 · Intervention Types: Biological
YA GSK4382276A Dose level 1 Group
Biological
Experimental Group · 1 Intervention: GSK4382276A Dose level 1 · Intervention Types: Biological
OA GSK4382276A GroupExperimental Group · 3 Interventions: GSK4382276A Dose level 1, GSK4382276A Dose level 2, GSK4382276A Dose level 3 · Intervention Types: Biological, Biological, Biological
YA Control Group
CombinationProduct
ActiveComparator Group · 1 Intervention: FDQ21A-NH · Intervention Types: CombinationProduct
OA Control Group
CombinationProduct
ActiveComparator Group · 1 Intervention: FDQ21A-NH · Intervention Types: CombinationProduct

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at day 62 and day 183

Who is running the clinical trial?

CureVac AGIndustry Sponsor
21 Previous Clinical Trials
44,312 Total Patients Enrolled
CureVacIndustry Sponsor
21 Previous Clinical Trials
44,312 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,647 Previous Clinical Trials
7,944,445 Total Patients Enrolled

Eligibility Criteria

Age 18 - 80 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are between and including 18 and 45 years of age (YAs) or between and including 60 and 80 years of age (OAs) at the time of the study intervention administration.
You have been informed of the study's purpose and the risks and benefits of participating in the study.
You have been using a method of contraception for 28 days or more prior to study intervention administration.
You are female and of non-childbearing potential.
References

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