A Clinical Study to Evaluate an Experimental Universal Influenza Vaccine, INFLUENZA G1 mHA, in Healthy Adults

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.

AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using food and drug administration (FDA) toxicity grading scale- Pain: Grade (G) 1 (mild; does not interfere with activity); G2 (moderate; requires modification in activity/use of medications); G3 (severe; inability to do usual activities/use of narcotic pain reliever); G4 (life threatening; hospitalization), Erythema and swelling: G 1 (mild; 25 -50 millimeter [mm]); G2 (moderate; 51 -100 mm); G3 (severe; greater than [>] 100 mm); G4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).

AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using FDA toxicity grading scale- Pain: Grade 1 (mild; does not interfere with activity); Grade 2 (moderate; requires modification in activity/use of medications); Grade 3 (severe; inability to do usual activities/use of narcotic pain reliever); Grade 4 (life threatening; hospitalization), Erythema and swelling: Grade 1 (mild; 25 -50 mm); Grade 2 (moderate; 51 -100 mm); Grade 3 (severe; >100 mm); Grade 4 (life threatening; hospitalization/necrosis or exfoliative dermatitis).

Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.

Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius [C]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).

AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius [C]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization).

Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Number of participants with solicited systemic AEs related to study vaccine were reported.

An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.

An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary.

An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).

An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization).

Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 1 are reported below.

Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 2 are reported below.

An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.

An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Number of participants with any unsolicited AEs related to study vaccine were reported.

An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with SAEs and SAEs related to study vaccine were reported.

Geometric mean concentration of antibodies binding to HA stem or full-length HA protein as measured by ELISA (H5-ELISA and mHA ELISA) was reported. HA stem derived protein vaccine antigen (mHA) derived from H1N1 A/California/07/2009 virus strain. Per-protocol Immunogenicity population was denoted as PPI. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.