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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ at day 22 (post-dose 1/pre-vaccination) and day 43 (post-dose 2/pre-vaccination)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 22 (post-dose 1/pre-vaccination) and day 43 (post-dose 2/pre-vaccination)
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 moreSecondary 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 moreTrial 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.
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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
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