Fig. 1: Study CONSORT diagram and overview of clinical study design. | Nature Communications

Fig. 1: Study CONSORT diagram and overview of clinical study design.

From: A group 1 hemagglutinin stem vaccine elicits broad humoral responses against influenza in phase 1/2a study

Fig. 1: Study CONSORT diagram and overview of clinical study design.

a CONSORT diagram showing the flow of healthy adult participants through the FLZ1001 study between 17th May 2023 and 19th Aug 2024. Participants were randomly assigned to either a low dose (LD; 45 µg INFLUENZA G1 mHA) or high dose (HD; 135 µg INFLUENZA G1 mHA) with or without aluminum hydroxide adjuvant (Al(OH)3). ¶: Discontinued due to non-compliance with study schedule; †: Discontinued due to non-compliance with study drug; ‡: Discontinued vaccination due to physician decision; ◊: Withdrawal by participant; Δ Participant moved. b Overview of FLZ1001 study regimens and sampling scheme. Participants were vaccinated at Day 1 and Day 57 with either a placebo dose or active vaccine. Participants in the active vaccine groups received two doses of INFLUENZA G1 mHA at 45 μg with or without Al(OH)3 or one or two doses of INFLUENZA G1 mHA at 135 μg, with or without Al(OH)3. Groups 3 and 8 received 2 doses of placebo at Day 1 and Day 57 and these two groups were combined for analysis. Participants were followed up until 1 year after the first vaccination. Vaccination and sampling time points are indicated with vertical lines (top). Vaccination (syringe), and safety and immunogenicity visits are indicated by symbols (bottom).

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