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Adjuvant

FLU-Q-PAN H7N9 Formulation 2_A Group for Flu

Phase 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 22 (post-dose 1/pre-vaccination) and day 43 (post-dose 2/pre-vaccination)
Awards & highlights

Study Summary

This trial will study whether a certain combination of H7N9 antigen and AS03 adjuvant system is safe and causes an immune response in healthy adults.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 22 (post-dose 1/pre-vaccination) and day 43 (post-dose 2/pre-vaccination)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 22 (post-dose 1/pre-vaccination) and day 43 (post-dose 2/pre-vaccination) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Any SAEs
Number of Participants With Any Solicited Administration Site Events
Number of Participants With Any Solicited Systemic Events
+8 more
Secondary outcome measures
Anti-microneutralization (MN) Antibody Titers Against Vaccine-homologous H7N9 for a Subset of Participants
HI Antibody Titers Against Vaccine-homologous H7N9
Mean Geometric Increase (MGI) of HI Antibody Titers Against Vaccine-homologous H7N9
+5 more

Trial Design

7Treatment groups
Active Control
Placebo Group
Group I: FLU-Q-PAN H7N9 Formulation 2_A GroupActive Control2 Interventions
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
Group II: FLU-Q-PAN H7N9 Formulation 3_B GroupActive Control2 Interventions
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
Group III: FLU-Q-PAN H7N9 Formulation 3_A GroupActive Control2 Interventions
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 3 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
Group IV: FLU-Q-PAN H7N9 Formulation 1_B GroupActive Control2 Interventions
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
Group V: FLU-Q-PAN H7N9 Formulation 1_A GroupActive Control2 Interventions
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 1 vaccine and AS03A adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
Group VI: FLU-Q-PAN H7N9 Formulation 2_B GroupActive Control2 Interventions
Healthy male and female participants who received two doses of FLU-Q-PAN H7N9 Formulation 2 vaccine and AS03B adjuvant. Participants received the first dose at Day 1 and the second dose at Day 22.
Group VII: Placebo GroupPlacebo Group1 Intervention
Healthy male and female participants who received two doses of placebo, the first dose at Day 1 and the second dose at Day 22.

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,066,639 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,097 Total Patients Enrolled

Frequently Asked Questions

~204 spots leftby Apr 2025