Influenza Prevention
Conditions
Brief summary
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.
Interventions
BIOLOGICALINFLUENZA G1 mHA
INFLUENZA G1 mHA will be administered intramuscularly.
BIOLOGICALPlacebo
Placebo will be administered intramuscularly.
BIOLOGICALAl(OH)3
Al(OH)3 will be administered intramuscularly.
Sponsors
Biomedical Advanced Research and Development Authority
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be healthy as confirmed by medical history, physical examination, vital signs, and clinical laboratory tests performed at screening * Contraceptive (birth control) use by female participants should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies. Before randomization, participants who were born female must be either: a) not of childbearing potential; b) of childbearing potential and practicing a highly effective method of contraception and agreeing to remain on such a method of contraception from signing the informed consent until 3 months after the last dose of study vaccine. Use of hormonal contraception should start at least 28 days before the first administration of study vaccine. Highly effective methods for this study include: hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion/ligation procedures, vasectomized partner (the vasectomized partner should be the sole partner for that participant), and sexual abstinence * All female participants of childbearing potential must: a) have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test at screening; b) have a negative urine beta-hCG pregnancy test immediately prior to each study vaccine administration * Must be healthy on the basis of clinical laboratory tests performed at screening. If the results of the laboratory screening tests are outside the laboratory normal reference ranges and additionally within the limits of toxicity Grade 2 according to the US FDA toxicity scale the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant and appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
Exclusion criteria
* Contraindication to IM injections and blood draws, example, bleeding disorders * Clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (\>=) 38.0 degree Celsius (100.4 degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor * History of severe allergic reaction (for example, anaphylaxis) or other serious adverse reactions to vaccines or vaccine excipients (specifically the excipients of the study vaccine\[s\]) * Abnormal function of the immune system resulting from: a) clinical conditions (example, autoimmune disease or immunodeficiency) or their treatments expected to have an impact on the immune response elicited by the study vaccine; b) chronic or recurrent use of systemic corticosteroids within 2 months before administration of study vaccine and during the study; c) administration of antineoplastic and immunomodulating agents or radiotherapy expected to have an impact on the immune response elicited by the study vaccine within 6 months before administration of study vaccine and during the study * History of acute polyneuropathy (example, Guillain-Barré syndrome) or chronic idiopathic demyelinating polyneuropathy * Received treatment with immunoglobulins (including monoclonal antibodies) expected to impact the vaccine-induced immune response in the 2 months or blood products in the 3 months before the planned administration of the first dose of study vaccine or has any plans to receive such treatment during the study. * Received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine, or received an investigational biological product within 3 months or 5 half-lives, whichever is longer, before the planned study intervention, or is currently enrolled or plans to participate in another investigational study or observational clinical study during the course of this study * Pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study vaccine. Oocyte donation is prohibited while enrolled in this study * Received or plans to receive: licensed live attenuated vaccines - within 28 days before or after planned administration of the first or subsequent study vaccination\[s\]; other licensed (not live) vaccines (not including seasonal influenza vaccines) - within 14 days before or after planned administration of the first or subsequent study vaccination\[s\]; seasonal influenza vaccines - within 4 months before planned administration of the first study vaccination until the end of the study (that is, any individual who requires a seasonal influenza vaccination for occupational or other reasons will be excluded) * Has received a pandemic influenza vaccine (other than Hemagglutinin Type 1 and Neuraminidase Type 1 \[H1N1\]) in a previous pandemic influenza vaccine study at any time prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | From first vaccination (Day 1) up to Day 365 | 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. |
| Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) | 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. |
| Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) | 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. |
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) | 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). |
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) | AE: any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have a causal relationship with intervention. Solicited local AEs used to assess reactogenicity of vaccine. Pre-defined local AEs (pain/tenderness, erythema and swelling at injection site) were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity was assessed using FDA toxicity grading scale- Pain: Grade 1 (mild; does not interfere with activity); Grade 2 (moderate; requires modification in activity/use of medications); Grade 3 (severe; inability to do usual activities/use of narcotic pain reliever); Grade 4 (life threatening; hospitalization), Erythema and swelling: Grade 1 (mild; 25 -50 mm); Grade 2 (moderate; 51 -100 mm); Grade 3 (severe; \>100 mm); Grade 4 (life threatening; hospitalization/necrosis or exfoliative dermatitis). |
| Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | From Day 1 up to Day 365 | Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site) AEs for which participants were specifically questioned and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). Solicited local AEs included injection site pain/tenderness, erythema, and swelling at the vaccination site. |
| Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | From Day 57 up to Day 365 | 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. |
| Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85) | 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 Solicited Systemic AEs Within 7 Days After Vaccination 1 | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) | 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 AE Within 7 Days After Vaccination 2 | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) | 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 Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) | 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). |
| Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) | AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. AE does not necessarily have causal relationship with intervention. Solicited systemic AEs used to assess reactogenicity of vaccine. Systemic events (fatigue, headache, nausea, myalgia, fever) for which participants were specifically questioned and were noted by participants in a diary for 7 days post vaccination (day of vaccination and subsequent 7 days). Severity assessed by FDA toxicity grading scale- Fever: Grade (G) 1 (mild; 38.0-38.4 degrees Celsius \[C\]), G2 (moderate; 38.5-38.9 degrees C), G3 (severe; 39.0-40.0 degrees C), G4 (\>40.0 degrees C); fatigue, headache, nausea and myalgia: G1 (mild; does not interfere with activity), G2 (moderate; requires modification in activity/use of medications), G3 (severe; inability to do usual activities/use of medications); G4 (life threatening; hospitalization). |
| Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | From Day 1 up to Day 365 | Duration of solicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs were used to assess the reactogenicity of the study vaccine. Systemic events (fatigue, headache, nausea, myalgia, and fever) for which participants were specifically questioned, and which were noted by participants in a diary for 7 days post vaccination (day of vaccination and the subsequent 7 days). |
| Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | From Day 57 up to Day 365 | 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). |
| Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8) | 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. |
| Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64) | 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. |
| Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29) | 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 Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29) | 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). |
| Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85) | An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. The severity of AEs was assessed by FDA toxicity grading scale: Grade 1 (mild; symptoms causing no or minimal interference with usual social and functional activities); Grade 2 (moderate; symptoms causing greater than minimal interference with usual social and functional activities; Grade 3 (severe; symptoms causing inability to perform usual social and functional activities and requires medical intervention); Grade 4 (life threatening; hospitalization). |
| Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1 | From Day 1 up to Day 365 | Duration of unsolicited AEs was defined as number of days from the start of the event until resolution of the event. An AE was any untoward medical occurrence in clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have causal relationship with intervention. An unsolicited AE was defined as all AEs for which the participants were not specifically questioned in the participant's reactogenicity diary. Unsolicited AEs that occurred within 28 days after vaccination 1 are reported below. |
| Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | From Day 57 up to Day 365 | 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. |
| Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29) | 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. |
| Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | Days 29 and 85 | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 25 |
| 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). | 25 |
| 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). | 25 |
| 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). | 25 |
| 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). | 25 |
| 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). | 25 |
| 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). | 20 |
| Total | 170 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 | 1 | 3 | 1 |
| Overall Study | Non- Compliance With Study Schedule | 0 | 0 | 2 | 1 | 0 | 0 | 2 |
| Overall Study | Other | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Total | Group 3 and Group 8: Placebo (Two Doses) | Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 31.6 Years STANDARD_DEVIATION 7.77 | 32.7 Years STANDARD_DEVIATION 7.6 | 31.6 Years STANDARD_DEVIATION 7.69 | 32.5 Years STANDARD_DEVIATION 7.96 | 32.0 Years STANDARD_DEVIATION 7.06 | 35.1 Years STANDARD_DEVIATION 7.22 | 34.3 Years STANDARD_DEVIATION 7.13 | 31.2 Years STANDARD_DEVIATION 8.31 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 68 Participants | 9 Participants | 7 Participants | 12 Participants | 11 Participants | 12 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 102 Participants | 11 Participants | 18 Participants | 13 Participants | 14 Participants | 13 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 38 Participants | 3 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 129 Participants | 17 Participants | 20 Participants | 20 Participants | 20 Participants | 19 Participants | 18 Participants |
| Region of Enrollment United States | 25 Participants | 170 Participants | 20 Participants | 25 Participants | 25 Participants | 25 Participants | 25 Participants | 25 Participants |
| Sex: Female, Male Female | 8 Participants | 89 Participants | 12 Participants | 16 Participants | 13 Participants | 18 Participants | 15 Participants | 7 Participants |
| Sex: Female, Male Male | 17 Participants | 81 Participants | 8 Participants | 9 Participants | 12 Participants | 7 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 20 |
| other Total, other adverse events | 9 / 25 | 16 / 25 | 8 / 25 | 18 / 25 | 9 / 25 | 16 / 25 | 9 / 20 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 2 / 25 | 0 / 25 | 0 / 25 | 0 / 20 |
Outcome results
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.
Time frame: From Day 1 up to Day 365
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site pain | 1.0 Days |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site swelling | 1.0 Days |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site erythema | 1.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site swelling | 1.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site erythema | 1.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site pain | 2.5 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site pain | 4.0 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site erythema | 1.0 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site swelling | 5.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site pain | 2.0 Days |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site pain | 1.0 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site pain | 2.0 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site erythema | 1.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 1 | Vaccination site pain | 3.0 Days |
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.
Time frame: From Day 57 up to Day 365
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | Vaccination site pain | 1.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | Vaccination site pain | 2.0 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | Vaccination site pain | 2.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | Vaccination site pain | 1.5 Days |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | Vaccination site pain | 1.0 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | Vaccination site pain | 1.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | Vaccination site pain | 1.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | Vaccination site swelling | 1.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Solicited Local AEs That Occurred Within 7 Days After Vaccination 2 | Vaccination site erythema | 1.0 Days |
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).
Time frame: From Day 1 up to Day 365
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Headache | 3.0 Days |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Myalgia | 1.0 Days |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Nausea | 1.0 Days |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Fatigue | 2.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Myalgia | 3.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Fatigue | 3.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Headache | 4.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Nausea | 1.0 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Headache | 1.5 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Fatigue | 1.5 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Myalgia | 1.0 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Nausea | 1.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Myalgia | 1.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Headache | 1.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Fatigue | 1 Days |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Headache | 5.5 Days |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Nausea | 1.0 Days |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Myalgia | 3.5 Days |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Fatigue | 1.5 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Headache | 4.5 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Fatigue | 4.5 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Nausea | 5.0 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Myalgia | 1.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Myalgia | 1.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 1 | Fatigue | 1.0 Days |
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).
Time frame: From Day 57 up to Day 365
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Fatigue | 6.0 Days |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Headache | 9.0 Days |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Nausea | 1.0 Days |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Myalgia | 1.5 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Myalgia | 2.5 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Headache | 5.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Fatigue | 6.0 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Myalgia | 2.0 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Fatigue | 1.0 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Headache | 3.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Myalgia | 2.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Nausea | 1.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Fatigue | 1.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Headache | 3.0 Days |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Fatigue | 1.0 Days |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Headache | 2.0 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Myalgia | 1.0 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Nausea | 3.5 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Headache | 4.0 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Fatigue | 4.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Nausea | 1.5 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Pyrexia | 8.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Fatigue | 1.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Solicited Systemic AEs That Occurred Within 7 Days After Vaccination 2 | Headache | 2.0 Days |
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.
Time frame: From Day 1 up to Day 365
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1 | Nasopharyngitis | 11.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1 | Diarrhoea | 1.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1 | Ventricular extrasystoles | 1.0 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1 | Dermatitis contact | 11.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 1 | Anaemia | 57.0 Days |
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.
Time frame: From Day 57 up to Day 365
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Nephrolithiasis | 14.0 Days |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Arthralgia | 3.0 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Influenza like illness | 6.0 Days |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Leukopenia | 52.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Hypertension | 252.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Otitis media acute | 7.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Influenza like illness | 7.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Blood pressure increased | 20.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Transient ischaemic attack | 3.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Rhinorrhoea | 2.0 Days |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Gastroenteritis | 7.0 Days |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Anaemia | 34.0 Days |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Influenza like illness | 4.0 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Sinusitis | 8.0 Days |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Influenza like illness | 7.0 Days |
| Group 3 and Group 8: Placebo (Two Doses) | Duration of Unsolicited AEs That Occurred Within 28 Days After Vaccination 2 | Pulmonary embolism | 92.0 Days |
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.
Time frame: From first vaccination (Day 1) up to Day 365
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE | 0 Participants |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE related to study vaccine | 0 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE | 0 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE related to study vaccine | 0 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE | 0 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE related to study vaccine | 0 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE | 2 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE related to study vaccine | 0 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE | 0 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE related to study vaccine | 0 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE | 0 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE related to study vaccine | 0 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE | 0 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Serious Adverse Events (SAEs) and SAEs Related to Study Vaccine | SAE related to study vaccine | 0 Participants |
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.
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | 5 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | 12 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | 3 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | 13 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | 6 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | 14 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Solicited Local Adverse Events (AEs) Within 7 Days After Vaccination 1 | 1 Participants |
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.
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | 5 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | 9 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | 5 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | 8 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | 2 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | 5 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Solicited Local AEs Within 7 Days After Vaccination 2 | 2 Participants |
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.
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | 7 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | 12 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | 6 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | 9 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | 7 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | 12 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 1 | 4 Participants |
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.
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | 4 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | 8 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | 7 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | 9 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | 6 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | 8 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Solicited Systemic AEs Related to Study Vaccine Within 7 Days After Vaccination 2 | 3 Participants |
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).
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 | 7 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 | 12 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 | 6 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 | 9 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 | 7 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 | 12 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Solicited Systemic AEs Within 7 Days After Vaccination 1 | 4 Participants |
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).
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 | 4 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 | 8 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 | 7 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 | 9 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 | 6 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 | 8 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Solicited Systemic AE Within 7 Days After Vaccination 2 | 4 Participants |
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.
Time frame: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | 0 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | 0 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | 0 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | 0 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | 0 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | 0 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 1 | 0 Participants |
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.
Time frame: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | 0 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | 1 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | 0 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | 0 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | 0 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | 0 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Unsolicited AEs Related to Study Vaccine Within 28 Days After Vaccination 2 | 0 Participants |
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.
Time frame: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | 1 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | 1 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | 0 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | 1 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | 0 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | 1 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 1 | 1 Participants |
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.
Time frame: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | 1 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | 1 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | 2 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | 3 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | 2 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | 2 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Unsolicited AEs Within 28 Days After Vaccination 2 | 1 Participants |
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).
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | 1 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 1 | 0 Participants |
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).
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | 0 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | 0 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | 0 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | 0 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | 0 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | 0 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Local AEs Within 7 Days After Vaccination 2 | 0 Participants |
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).
Time frame: Within 7 Days after vaccination 1 on Day 1 (from Day 1 up to Day 8)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | 0 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AEs Within 7 Days After Vaccination 1 | 0 Participants |
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).
Time frame: Within 7 Days after vaccination 2 on Day 57 (from Day 57 up to Day 64)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | 0 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | 0 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | 0 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | 1 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | 1 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | 0 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Worst Grade (at Least Grade 3) Solicited Systemic AE Within 7 Days After Vaccination 2 | 0 Participants |
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).
Time frame: Within 28 Days after vaccination 1 on Day 1 (from Day 1 up to Day 29)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | 0 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | 0 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | 0 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | 0 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | 0 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | 0 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 1 | 0 Participants |
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).
Time frame: Within 28 Days after vaccination 2 on Day 57 (from Day 57 up to Day 85)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | 0 Participants |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | 0 Participants |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | 0 Participants |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | 1 Participants |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | 1 Participants |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | 0 Participants |
| Group 3 and Group 8: Placebo (Two Doses) | Number of Participants With Worst Grade (At Least Grade 3) Unsolicited AEs Within 28 Days After Vaccination 2 | 0 Participants |
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.
Time frame: Days 29 and 85
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 29 | 2919 ELISA Unit per milliliter (EU)/mL |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 85 | 3015 ELISA Unit per milliliter (EU)/mL |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 29 | 27285 ELISA Unit per milliliter (EU)/mL |
| Group 1: Influenza A G1 mHA 45 mcg (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 85 | 28875 ELISA Unit per milliliter (EU)/mL |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 85 | 29496 ELISA Unit per milliliter (EU)/mL |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 29 | 28343 ELISA Unit per milliliter (EU)/mL |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 29 | 2990 ELISA Unit per milliliter (EU)/mL |
| Group 2: Influenza A G1 mHA 45 mcg With Al(OH)3 (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 85 | 2892 ELISA Unit per milliliter (EU)/mL |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 29 | 31894 ELISA Unit per milliliter (EU)/mL |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 85 | 3413 ELISA Unit per milliliter (EU)/mL |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 29 | 3240 ELISA Unit per milliliter (EU)/mL |
| Group 4: Influenza A G1 mHA 135 mcg (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 85 | 36459 ELISA Unit per milliliter (EU)/mL |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 29 | 4468 ELISA Unit per milliliter (EU)/mL |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 85 | 4276 ELISA Unit per milliliter (EU)/mL |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 29 | 43631 ELISA Unit per milliliter (EU)/mL |
| Group 5: Influenza A G1 mHA 135 mcg With Al(OH)3 (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 85 | 45667 ELISA Unit per milliliter (EU)/mL |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 29 | 3998 ELISA Unit per milliliter (EU)/mL |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 85 | 31845 ELISA Unit per milliliter (EU)/mL |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 85 | 3044 ELISA Unit per milliliter (EU)/mL |
| Group 6: Influenza A G1 mHA 135 mcg (First Dose) + Placebo (Second Dose) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 29 | 44575 ELISA Unit per milliliter (EU)/mL |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 85 | 3087 ELISA Unit per milliliter (EU)/mL |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 29 | 5468 ELISA Unit per milliliter (EU)/mL |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 29 | 57306 ELISA Unit per milliliter (EU)/mL |
| Group 7: Influenza A G1 mHA 135 mcg With Al(OH)3 (First Dose) + Placebo (Second Dose) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 85 | 32809 ELISA Unit per milliliter (EU)/mL |
| Group 3 and Group 8: Placebo (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 29 | 3337 ELISA Unit per milliliter (EU)/mL |
| Group 3 and Group 8: Placebo (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 29 | 329 ELISA Unit per milliliter (EU)/mL |
| Group 3 and Group 8: Placebo (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H5 A/Vietnam/1203/2004 ELISA: Day 85 | 363 ELISA Unit per milliliter (EU)/mL |
| Group 3 and Group 8: Placebo (Two Doses) | Geometric Mean Concentration of Antibodies Binding to Hemagglutinin (HA) Stem or Full-length HA Protein as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | H1 mHA A/California/07/2009 ELISA: Day 85 | 3383 ELISA Unit per milliliter (EU)/mL |