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| ID | Type | Description | Link |
|---|---|---|---|
| VAC21148FLZ1001 | Other Identifier | Janssen Vaccines & Prevention B.V. | |
| 2019-004635-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Biomedical Advanced Research and Development Authority | FED |
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The primary purpose of this study is to evaluate safety/ reactogenicity of INFLUENZA G1 mini-hemagglutinin stem-derived protein vaccine antigen (mHA), with or without Al(OH)3 adjuvant, in healthy adults greater than or equal to (>=) 18 to less than or equal to (<=) 45 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INFLUENZA G1 mHA Dose Level 1 | Experimental | Participants will receive single intramuscular (IM) injection of INFLUENZA G1 mHA Dose level 1 on Days 1 and 57 in Cohort 1. |
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| INFLUENZA G1 mHA Dose Level 1 along with Al(OH)3 | Experimental | Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 1 with Aluminum Hydroxide (Al[OH])3 adjuvant on Days 1 and 57 in Cohort 1. |
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| Placebo | Placebo Comparator | Participants will receive IM injection of placebo on Days 1 and 57 in Cohorts 1 and 2. |
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| INFLUENZA G1 mHA Dose Level 2 | Experimental | Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Days 1 and 57 in Cohort 2. |
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| INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 | Experimental | Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Days 1 and 57 in Cohort 2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INFLUENZA G1 mHA | Biological | INFLUENZA G1 mHA will be administered intramuscularly. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | 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. | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) |
| Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | 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. | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) |
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Floridian Clinical Research LLC | Miami Lakes | Florida | 33016 | United States | ||
| Johnson County Clin-Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41974675 | Derived | Hertoghs N, Tang C, van Paassen V, Jongeneelen M, Tolboom J, Yieh L, Wang M, Kaszas K, McLean C, van den Berg S, Lowson D, Hu W, Aguilar Z, Hendriks J, Kuipers H, Kulke S, Sadoff J, Brandenburg B, Zahn R. A group 1 hemagglutinin stem vaccine elicits broad humoral responses against influenza in phase 1/2a study. Nat Commun. 2026 Apr 13;17(1):3451. doi: 10.1038/s41467-026-70396-1. |
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The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Study consisted of 2 Cohorts: Cohort 1 (Group 1 to 3) and Cohort 2 (Group 4 to 8). Participants were enrolled in a staggered approach with safety evaluations (Day 8) in place before extending enrollment in each cohort and progressing from one cohort to the next. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Participants received a single dose of 45 micrograms (mcg) Influenza A Group 1 (G1) hemagglutinin stem-derived protein antigen (mHA) vaccine as intramuscular (IM) injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2023 | Aug 18, 2025 |
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| INFLUENZA G1 mHA Dose Level 2 + Placebo | Experimental | Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 on Day 1 and placebo on Day 57 in Cohort 2. |
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| INFLUENZA G1 mHA Dose Level 2 along with Al(OH)3 + Placebo | Experimental | Participants will receive single IM injection of INFLUENZA G1 mHA Dose level 2 with Al(OH)3 adjuvant on Day 1 and placebo on Day 57 in Cohort 2. |
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| Placebo | Biological | Placebo will be administered intramuscularly. |
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| Al(OH)3 | Biological | Al(OH)3 will be administered intramuscularly. |
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| Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) |
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | 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). | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) |
| Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | 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. | From Day 1 up to Day 365 |
| Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | 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. | From Day 57 up to Day 365 |
| Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 | 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). | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) |
| Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 | 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). | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) |
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | 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). | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) |
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | 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). | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) |
| Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | 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). | From Day 1 up to Day 365 |
| Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | 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). | From Day 57 up to Day 365 |
| Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | 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. | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) |
| Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | 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. | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) |
| Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | 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. | Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29) |
| Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | 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. | Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85) |
| Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | 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). | Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29) |
| Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | 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). | Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85) |
| Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1 | 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. | From Day 1 up to Day 365 |
| Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | 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. | From Day 57 up to Day 365 |
| Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | 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. | Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29) |
| Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | 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. | Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85) |
| Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | 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. | From first vaccination (Day 1) up to Day 365 |
| Days 29 and 85 |
| Lenexa |
| Kansas |
| 66219 |
| United States |
| Clinical Trials Managements, LLC | Metairie | Louisiana | 70006 | United States |
| CTI Clinical Trial and Consulting Services | Cincinnati | Ohio | 45212 | United States |
| FG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Aluminum Hydroxide (Al[OH]3) vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| FG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| FG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| FG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| FG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| FG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| Number of Participants Who Received Vaccination 1 |
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| Number of Participants Who Received Vaccination 2 |
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| Number of Participants Who Received 2 Doses of Placebo in Group 3 |
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| Number of Participants Who Received 2 Doses of Placebo in Group 8 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| BG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| BG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| BG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| BG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| BG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| BG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | 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. | Full analysis set (FAS) included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) |
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| Primary | Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | 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. | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) |
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| Primary | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | 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). | FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) |
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| Primary | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | 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). | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) |
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| Primary | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | 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. | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicated that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Median | Full Range | Days | From Day 1 up to Day 365 |
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| Primary | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | 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. | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicated that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Median | Full Range | Days | From Day 57 up to Day 365 |
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| Primary | Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 | 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). | FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) |
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| Primary | Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 | 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). | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) |
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| Primary | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | 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). | FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) |
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| Primary | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | 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). | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) |
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| Primary | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | 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). | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicated that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Median | Full Range | Days | From Day 1 up to Day 365 |
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| Primary | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | 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). | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicated that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Median | Full Range | Days | From Day 57 up to Day 365 |
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| Primary | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | 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. | FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) |
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| Primary | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | 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. | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) |
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| Primary | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | 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. | FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29) |
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| Primary | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | 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. | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85) |
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| Primary | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | 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). | FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29) |
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| Primary | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | 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). | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85) |
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| Primary | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1 | 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. | FAS: all participants with at least 1 vaccination documented. N=number of participants evaluable for this outcome measure; n (number analyzed)=number of participants evaluable for specified rows. N=0 indicated that data was not collected and analyzed as no participant experienced any AE in specified arm. n=0 indicated that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Median | Full Range | Days | From Day 1 up to Day 365 |
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| Primary | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | 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. | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants evaluable for this outcome measure and 'n' (number analyzed) signifies number of participants evaluable for specified rows. n=0 indicates that no participant experienced the specified AE in respective arm. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Median | Full Range | Days | From Day 57 up to Day 365 |
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| Primary | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | 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. | FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29) |
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| Primary | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | 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. | FAS included all participants with at least 1 vaccination documented. Here 'N' (overall number of participants analyzed) refers to the number of participants who received vaccination 2. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85) |
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| Primary | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | 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. | FAS included all participants with at least 1 vaccination documented. As planned, combined data was collected and analyzed for participants who received Placebo in Groups 3 and 8. | Posted | Count of Participants | Participants | From first vaccination (Day 1) up to Day 365 |
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| Secondary | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | 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. | PPI included all randomized and vaccinated participants for whom immunogenicity data were available excluding samples taken on or after the date when a participant experiences a major protocol deviation expected to impact the immunogenicity outcomes. 'n' (number analyzed)=number of participants evaluable for specified rows. n=0 indicates that no participant was available for the analysis in the respective arm for specified category. | Posted | Geometric Mean | 95% Confidence Interval | ELISA Unit per milliliter (EU)/mL | Days 29 and 85 |
|
All cause mortality: From baseline (pre-vaccination Day 1) up to Day 365; SAE: From the day of vaccination 1 (Day 1) up to Day 365; Other AEs: Solicited AEs: within 7 days after vaccination 1 on Day 1 (up to Day 8), within 7 days after vaccination 2 on Day 57 (up to Day 64); Unsolicited AEs: within 28 days after vaccination 1 on Day 1 (up to Day 29 ), within 28 days after vaccination 2 on Day 57 (up to Day 85)
All Cause Mortality: All randomized participants. SAE and Other AEs: FAS included all participants with at least 1 vaccination documented.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). | 0 | 25 | 0 | 25 | 9 | 25 |
| EG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). | 0 | 25 | 0 | 25 | 16 | 25 |
| EG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). | 0 | 25 | 0 | 25 | 8 | 25 |
| EG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). | 0 | 25 | 2 | 25 | 18 | 25 |
| EG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). | 0 | 25 | 0 | 25 | 9 | 25 |
| EG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). | 0 | 25 | 0 | 25 | 16 | 25 |
| EG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). | 0 | 20 | 0 | 20 | 9 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 27.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Nausea (Solicited) | Gastrointestinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Fatigue (Solicited) | General disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Pyrexia (Solicited) | General disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Vaccination Site Erythema (Solicited) | General disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Vaccination Site Pain (Solicited) | General disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Vaccination Site Swelling (Solicited) | General disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Myalgia (Solicited) | Musculoskeletal and connective tissue disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Headache (Solicited) | Nervous system disorders | MedDRA Version 27.0 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.0 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Lead | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2024 | Aug 18, 2025 | SAP_002.pdf |
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) |
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG001 |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) |
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG001 | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) |
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) |
Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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Participants received a single dose of 45 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG002 | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG003 | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG004 | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG005 | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Participants received a single dose of 135 mcg Influenza A G1 mHA with Al(OH)3 vaccine as IM injection on Day 1 and a single dose of placebo matching to Influenza A G1 mHA vaccine on Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
| OG006 | Group 3 and Group 8: Placebo (Two Doses) | Participants received a single dose of placebo matching to Influenza A G1 mHA vaccine as IM injection on Day 1 and Day 57. Participants were followed up for safety for a minimum period of 28 days after each vaccination (up to Day 29 and Day 85 respectively) and for long term safety until 1 year after the first vaccination (Day 365). |
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