Influenza Infection
Conditions
Keywords
Flu, Seasonal Allergy, Respiratory Illness, Flu Virus, Viral Infection
Brief summary
Background: The flu is a common viral infection that can be deadly for certain people. Vaccines against flu have been developed to teach the body to prevent or fight the infection. A new vaccine may help the body to make an immune response to H1 flu, a flu strain that infects humans. Objective: To test the safety and effectiveness of the H1 Stabilized Stem Ferritin vaccine (VRC-FLUNPF099-00-VP). Eligibility: Healthy people ages 18-70 years old who got at least 1 licensed flu vaccine since January 1, 2014. Design: Participants received 1 or 2 vaccinations by injections (shots) in the upper arm muscle over 4 months. Participants received a thermometer and recorded their temperature and symptoms every day a diary card for 7 days after each injection. The injection site was checked for redness, swelling, or bruising. Participants had 9-11 follow-up visits over 12-15 months. At follow-up visits, participants had blood drawn and were checked for health changes or problems. Participants who reported influenza-like illness had nose and throat swabs for evaluation of viral infection. Some participants had apheresis. A needle was placed into a vein in both arms. Blood was removed through a needle in the vein of one arm. A machine removed the white blood cells and then the rest of the blood was returned to the participant through a needle in the other arm. A separate consent was provided to participants for genetic testing on their samples.
Detailed description
Study Design: This was a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of VRC-FLUNPF099-00-VP in two regimens. The hypotheses were that the vaccine is safe and tolerable and will elicit an immune response. The primary objective was to evaluate the safety and tolerability of the investigational vaccine in healthy adults. Secondary objectives were related to immunogenicity of the investigational vaccine and dosing regimen. Study Products: The investigational vaccine, VRC-FLUNPF099-00-VP (H1ssF\_3928), was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID) and is composed of Helicobacter pylori non-heme ferritin assembled with influenza virus H1 haemagglutinin (HA) insert to form a nanoparticle displaying eight HA stabilized stem trimers from A/New Caledonia/20/1999 (H1N1) influenza. The vaccine was supplied in single-use vials at a concentration of 180 mcg/mL. H1ssF\_3928 was administered intramuscularly (IM) in the deltoid muscle via needle and syringe. Participants: Healthy adults between the ages of 18-70 years, inclusive. Study Plan: The study evaluated the safety, tolerability and immunogenicity of 1 or 2 doses of the H1ssF\_3928 vaccine in a dose-escalation design. In Group 1, five participants received a single low dose (20 mcg) of H1ssF\_3928 on Day 0. For Group 1, the protocol required 1 vaccination visit, about 9 follow-up visits, and a telephone contact after vaccination. Once the low dose was assessed as safe and well tolerated, enrollment began for Group 2A. Groups 2A, 2B, 2C, and 2D were stratified by age as shown in the vaccination schema below. In Group 2A, participants received a higher dose (60 mcg) of H1ssF\_3928 on Day 0. Once this higher dose was assessed as safe and well tolerated, participants in Group 2A received a second vaccination at Week 16 and enrollment began for Groups 2B, 2C, and 2D. For Groups 2A, 2B, 2C, and 2D, the protocol required 2 vaccination visits, about 11 follow-up visits, and a telephone contact after each vaccination. Group 2A completed the product administration schedule per protocol. While most participants in Groups 2B-2D completed the second dose administration per protocol, one participant was not able to receive the second dose due to moving out of the area and 11 participants were not able to receive their second dose due to the COVID-19 pandemic. For all groups, solicited reactogenicity was evaluated using a 7-day diary card. Assessment of vaccine safety included clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study. VRC 321 Vaccination Schema: Group: 1; Age Cohort: 18-40; Participants: 5; Day 0: 20 mcg Group: 2A; Age Cohort: 18-40; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg Group: 2B; Age Cohort: 41-49; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg Group: 2C; Age Cohort: 50-59; Participants: 12; Day 0: 60 mcg; Week 16: 60 mcg Group: 2D; Age Cohort: 60-70; Participants: 11\*; Day 0: 60 mcg; Week 16: 60 mcg Total: 52\* \*Recruitment for the final open group, Group 2D, was ongoing to meet the accrual target of 53 participants. However, due to the COVID-19 pandemic, enrollment was discontinued with a total of 52 participants enrolled. Study Duration: Group 1: Participants were evaluated for 52 weeks following the vaccine administration and through an influenza season. Groups 2A, 2B, 2C, 2D: Participants were evaluated for 52 weeks following the last vaccine administration and through an influenza season.
Interventions
BIOLOGICALVRC-FLUNPF099-00-VP (H1ssF_3928)
The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF\_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults between the ages of 18-70 years inclusive 2. Based on history and examination, in good general health and without history of any of the conditions listed in the
Exclusion criteria
3. Received at least one licensed influenza vaccine from 2014 to the present 4. Able and willing to complete the informed consent process 5. If enrolled in Group 1: Available for clinic visits for 52 weeks after enrollment and through an influenza season 6. If enrolled in Group 2A, 2B, 2C, or 2D: Available for clinic visits for 68 weeks after enrollment and through an influenza season 7. Willing to have blood samples collected, stored indefinitely, and used for research purposes 8. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process 9. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 28 days before enrollment Laboratory Criteria within 28 days before enrollment 10. White blood cells (WBC) and differential either within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval 11. Total lymphocyte count greater than or equal to 800 cells/mm\^3 12. Platelets = 125,000 - 500,000/mm3 13. Hemoglobin within institutional normal range 14. Serum iron either within institutional normal range or accompanied by the site PI or designee approval 15. Serum ferritin within institutional normal range or accompanied by the site PI or designee approval 16. Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN) 17. Aspartate aminotransferase (AST) less than or equal to 1.25 x institutional ULN 18. Alkaline phosphatase (ALP) \<1.1 x institutional ULN 19. Total bilirubin within institutional normal range 20. Serum creatinine less than or equal to 1.1 x institutional ULN 21. Negative for HIV infection by an FDA-approved method of detection Criteria applicable to women of childbearing potential: 22. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment 23. Agreed to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Day 0 through the study participation, up to Week 68 | Any abnormal laboratory results recorded after product administration as unsolicited adverse events (AEs) are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete blood count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at Days 14, 28, 280, 364 and 476. Iron and serum ferritin were collected at Day 28. Creatinine results were collected at Day 14. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used. |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | 7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17 | Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007. |
| Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | 7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17 | Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007. |
| Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Day 0 through 4 weeks after each H1ssF_3928 product administration, up to Week 20 | Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza and new chronic medical conditions that required ongoing medical management (reported as separate outcomes) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. |
| Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration | Day 0 through the study participation, up to Week 68 | SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. |
| Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration | Day 0 through the study participation, up to Week 68 | Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the first study product administration through the last study visit. |
| Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Day 0 through the study participation, up to Week 68 | New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Baseline to 2 weeks after 1st dose for participants who received a single injection, at Week 2 or From Baseline to 2 weeks after 1st dose and from Week 16 to 2 weeks after 2nd dose for participants who received two injections, at Weeks 2 and 18 | Pseudoviral neutralization antibody titers were determined against the homologous H1N1 A/New Caledonia/20/99 virus, and were summarized using geometric mean 80% inhibitory concentration (IC80). |
Countries
United States
Participant flow
Recruitment details
Healthy adults were recruited at the NIH Clinical Center in Bethesda, Maryland.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years H1ssF\_3928 (20 mcg) administered intramuscularly (IM) by Needle/Syringe (Day 0)
VRC-FLUNPF099-00-VP (H1ssF\_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF\_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes. | 5 |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years H1ssF\_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
VRC-FLUNPF099-00-VP (H1ssF\_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF\_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes. | 12 |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years H1ssF\_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
VRC-FLUNPF099-00-VP (H1ssF\_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF\_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes. | 12 |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years H1ssF\_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
VRC-FLUNPF099-00-VP (H1ssF\_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF\_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes. | 12 |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years H1ssF\_3928 (60 mcg) administered IM by Needle/Syringe (Day 0 and Week 16)
VRC-FLUNPF099-00-VP (H1ssF\_3928): The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/1999 (H1N1) genetically fused to the ferritin protein from H. pylori. Purified H1ssF\_3928 particles display eight well-formed HA trimers that antigenically resemble the native H1 stem viral spikes. | 11 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 34.0 years STANDARD_DEVIATION 5.6 | 29.2 years STANDARD_DEVIATION 5.2 | 45.3 years STANDARD_DEVIATION 3.6 | 52.8 years STANDARD_DEVIATION 2.7 | 63.0 years STANDARD_DEVIATION 2.5 | 46.0 years STANDARD_DEVIATION 13 |
| Age, Customized 21-30 years | 2 Participants | 8 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants |
| Age, Customized 31-40 years | 3 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants |
| Age, Customized 41-50 years | 0 Participants | 0 Participants | 12 Participants | 3 Participants | 0 Participants | 15 Participants |
| Age, Customized 51-60 years | 0 Participants | 0 Participants | 0 Participants | 9 Participants | 1 Participants | 10 Participants |
| Age, Customized 61-70 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 10 Participants | 10 Participants |
| Body Mass Index (BMI) | 22.8 kg/m^2 STANDARD_DEVIATION 2.9 | 27.0 kg/m^2 STANDARD_DEVIATION 3.5 | 27.0 kg/m^2 STANDARD_DEVIATION 3.7 | 27.6 kg/m^2 STANDARD_DEVIATION 3 | 26.3 kg/m^2 STANDARD_DEVIATION 4.3 | 26.6 kg/m^2 STANDARD_DEVIATION 3.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 9 Participants | 12 Participants | 11 Participants | 11 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 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 |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 8 Participants | 7 Participants | 10 Participants | 10 Participants | 39 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 7 Participants | 7 Participants | 6 Participants | 28 Participants |
| Sex: Female, Male Male | 1 Participants | 8 Participants | 5 Participants | 5 Participants | 5 Participants | 24 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 47 |
| other Total, other adverse events | 2 / 5 | 8 / 12 | 8 / 12 | 7 / 12 | 7 / 11 | 30 / 47 |
| serious Total, serious adverse events | 0 / 5 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 47 |
Outcome results
Primary
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Local Symptom is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Time frame: 7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17
Population: Population included all enrolled participants who received at least one H1ssF\_3928 study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=52).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | None | 5 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | None | 5 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | None | 5 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | None | 5 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | None | 5 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Mild | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | None | 12 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | None | 8 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Mild | 4 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | None | 12 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Mild | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | None | 8 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Mild | 4 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | None | 12 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Mild | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Mild | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Mild | 1 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | None | 12 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | None | 11 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Mild | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | None | 11 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Mild | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | None | 12 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Mild | 1 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | None | 12 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | None | 12 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | None | 9 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Mild | 3 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | None | 12 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Mild | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | None | 12 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Mild | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Mild | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | None | 9 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Mild | 3 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Mild | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Mild | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | None | 11 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Mild | 2 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Mild | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | None | 9 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | None | 9 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | None | 11 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Mild | 2 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | None | 11 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Mild | 10 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | None | 42 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Mild | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | None | 52 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Mild | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Redness | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | None | 42 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Local Symptom | Mild | 10 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | Mild | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Pain/Tenderness | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Swelling | None | 52 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Skin Lesion | None | 52 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration
Participants recorded the occurrence of solicited symptoms on a diary card for 7 days after each study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for Any Systemic Symptom is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, modified from FDA Guidance - September 2007.
Time frame: 7 days after each H1ssF_3928 product administration, at approximately Week 1 and at approximately Week 17
Population: Population included all enrolled participants who received at least one H1ssF\_3928 study injection and provided safety data (via diary card and/or laboratory results) following the injection (N=52).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Mild | 1 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | None | 5 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | None | 5 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | None | 5 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | None | 5 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | None | 4 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Moderate | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | None | 5 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Mild | 1 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Mild | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | None | 4 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Severe | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | None | 5 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Mild | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | None | 12 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Mild | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | None | 12 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | None | 11 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | None | 10 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Mild | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Mild | 2 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | None | 10 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Mild | 2 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Mild | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Mild | 3 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | None | 9 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | None | 11 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | None | 11 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Mild | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Severe | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Moderate | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | None | 8 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Mild | 1 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | None | 11 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Mild | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Mild | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | None | 11 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Mild | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | None | 12 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | None | 12 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Mild | 1 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | None | 9 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Severe | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Mild | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Mild | 3 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Mild | 4 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | None | 12 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Moderate | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | None | 12 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | None | 9 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Mild | 2 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | None | 11 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Mild | 1 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | None | 10 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Mild | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | None | 12 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Mild | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | None | 12 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Mild | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | None | 12 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Mild | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | None | 9 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Mild | 3 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Mild | 3 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Moderate | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Severe | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | None | 12 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Mild | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Mild | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | None | 11 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | None | 10 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | None | 8 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Mild | 1 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Mild | 3 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | None | 9 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Mild | 2 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Mild | 2 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Mild | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | None | 9 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | None | 11 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Moderate | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Mild | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Severe | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | None | 11 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | None | 11 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Mild | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Mild | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Mild | 2 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Nausea | None | 50 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Mild | 6 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | None | 52 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Moderate | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | None | 46 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Malaise | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | None | 38 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Mild | 10 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | Mild | 2 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | Mild | 4 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Joint Pain | None | 52 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Myalgia | None | 48 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Any Systemic Symptom | Mild | 14 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Chills | None | 50 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | None | 42 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Temperature (Fever) | Severe | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Each H1ssF_3928 Product Administration | Headache | Severe | 0 Participants |
Primary
Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration
Any abnormal laboratory results recorded after product administration as unsolicited adverse events (AEs) are summarized. Safety laboratory parameters included hematology (hemoglobin, hematocrit, platelets, and white blood cell (WBC), red blood cell (RBC), neutrophil, lymphocyte, monocyte, eosinophil and basophil percents/counts) and chemistry (alanine aminotransferase (ALT), alanine aspartate (AST), alkaline phosphate (ALP), creatinine and total bilirubin). Complete blood count (CBC) with differential, total bilirubin, AST, ALT, and ALP results were collected at Days 14, 28, 280, 364 and 476. Iron and serum ferritin were collected at Day 28. Creatinine results were collected at Day 14. Institutional laboratory normal ranges as well as the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials FDA Guidance, September 2007 were used.
Time frame: Day 0 through the study participation, up to Week 68
Population: Population included all enrolled participants who had laboratory results available at any study visit post product administration.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | AST | 1 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Hemoglobin | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | ALT | 1 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Neutrophil Count | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product | 1 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | WBC Count | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Lymphocyte Count | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Lymphocyte Count | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | AST | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Hemoglobin | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs | 3 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product | 2 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | WBC Count | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | ALT | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Neutrophil Count | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Neutrophil Count | 2 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Lymphocyte Count | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | AST | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | WBC Count | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | ALT | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Hemoglobin | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs | 2 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product | 2 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product | 1 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs | 3 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | AST | 1 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | WBC Count | 1 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Hemoglobin | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | ALT | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Neutrophil Count | 1 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Lymphocyte Count | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product | 2 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | ALT | 2 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Neutrophil Count | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Hemoglobin | 1 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product | 3 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | WBC Count | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | AST | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs | 3 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Lymphocyte Count | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Total Number of Participants who had Any Abnormal Laboratory Results Reported as AEs | 12 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | ALT | 4 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | AST | 2 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | WBC Count | 1 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Hemoglobin | 2 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Neutrophil Count | 3 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Lymphocyte Count | 1 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Related to Study Product | 2 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Abnormal Laboratory Measures of Safety Following H1ssF_3928 Product Administration | Number of Participants with one or more Abnormal Laboratory Results AE Unrelated to Study Product | 10 Participants |
Primary
Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration
Influenza or influenza-like illness (ILI) were recorded in the study database from receipt of the first study product administration through the last study visit.
Time frame: Day 0 through the study participation, up to Week 68
Population: Population included all enrolled participants who received at least one H1ssF\_3928 study injection (N=52).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration | 1 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration | 3 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Influenza or Influenza-like Illness (ILIs) Following H1ssF_3928 Product Administration | 4 Participants |
Primary
Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration
New chronic medical conditions that required ongoing medical management were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 through the study participation, up to Week 68
Population: Population included all enrolled participants who received at least one H1ssF\_3928 study injection (N=52).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Unrelated to Study Product | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Related to Study Product | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Total Number of Participants with New Chronic Medical Conditions | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Unrelated to Study Product | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Related to Study Product | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Total Number of Participants with New Chronic Medical Conditions | 1 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Unrelated to Study Product | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Related to Study Product | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Total Number of Participants with New Chronic Medical Conditions | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Unrelated to Study Product | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Related to Study Product | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Total Number of Participants with New Chronic Medical Conditions | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Unrelated to Study Product | 1 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Related to Study Product | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Total Number of Participants with New Chronic Medical Conditions | 1 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Related to Study Product | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Total Number of Participants with New Chronic Medical Conditions | 2 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With New Chronic Medical Conditions Following H1ssF_3928 Product Administration | Unrelated to Study Product | 2 Participants |
Primary
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of the first study product administration through the visit scheduled for 4 weeks after each study product administration. At other time periods between study product administrations and when greater than 4 weeks after the last study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module), influenza-like illness (ILI) or influenza and new chronic medical conditions that required ongoing medical management (reported as separate outcomes) were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 through 4 weeks after each H1ssF_3928 product administration, up to Week 20
Population: Population included all enrolled participants who received at least one H1ssF\_3928 study injection (N=52).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Unrelated to Study Product | 1 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Related to Study Product | 0 Participants |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Total Number of Participants who had One or More Non-Serious Unsolicited AE | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Unrelated to Study Product | 5 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Related to Study Product | 1 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Total Number of Participants who had One or More Non-Serious Unsolicited AE | 6 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Unrelated to Study Product | 6 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Related to Study Product | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Total Number of Participants who had One or More Non-Serious Unsolicited AE | 6 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Unrelated to Study Product | 4 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Related to Study Product | 1 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Total Number of Participants who had One or More Non-Serious Unsolicited AE | 5 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Unrelated to Study Product | 4 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Related to Study Product | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Total Number of Participants who had One or More Non-Serious Unsolicited AE | 4 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Related to Study Product | 2 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Total Number of Participants who had One or More Non-Serious Unsolicited AE | 22 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following H1ssF_3928 Product Administration | Unrelated to Study Product | 20 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration
SAEs were recorded from receipt of first study product administration through the last expected study visit at Week 68. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Time frame: Day 0 through the study participation, up to Week 68
Population: Population included all enrolled participants who received at least one H1ssF\_3928 study injection (N=52).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration | 0 Participants |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration | 0 Participants |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration | 0 Participants |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration | 0 Participants |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration | 0 Participants |
| Overall Incidence H1ssF_3928 (20 mcg and 60 mcg) | Number of Participants With Serious Adverse Events (SAEs) Following H1ssF_3928 Product Administration | 0 Participants |
Secondary
Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen
Pseudoviral neutralization antibody titers were determined against the homologous H1N1 A/New Caledonia/20/99 virus, and were summarized using geometric mean 80% inhibitory concentration (IC80).
Time frame: Baseline to 2 weeks after 1st dose for participants who received a single injection, at Week 2 or From Baseline to 2 weeks after 1st dose and from Week 16 to 2 weeks after 2nd dose for participants who received two injections, at Weeks 2 and 18
Population: Baseline, Week 2, and Week 16 analyses included all who received at least one H1ssF\_3928 study injection for which samples were available (N=52, 51, and 36 respectively). Week 18 analysis included all who received two H1ssF\_3928 injections for which samples were available (N=32). Twelve (12) participants did not receive the 2nd injection: one Group 2B participant due to moving out of the area and 11 participants (4 in Group 2B, 3 in Group 2C and 4 in Group 2D) due to the COVID-19 pandemic.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 0 (Baseline, Pre-Administration) | 618 titer |
| Group 1: H1ssF_3928 (20 mcg), Ages 18-40 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 2 (14 Days After First Product Administration) | 916 titer |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 2 (14 Days After First Product Administration) | 888 titer |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 18 (14 Days After Second Product Administration) | 602 titer |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 16 (Second Product Administration) | 982 titer |
| Group 2A: H1ssF_3928 (60 mcg), Ages 18-40 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 0 (Baseline, Pre-Administration) | 536 titer |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 2 (14 Days After First Product Administration) | 566 titer |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 18 (14 Days After Second Product Administration) | 780 titer |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 0 (Baseline, Pre-Administration) | 212 titer |
| Group 2B: H1ssF_3928 (60 mcg), Ages 41-49 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 16 (Second Product Administration) | 725 titer |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 18 (14 Days After Second Product Administration) | 543 titer |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 0 (Baseline, Pre-Administration) | 170 titer |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 2 (14 Days After First Product Administration) | 651 titer |
| Group 2C: H1ssF_3928 (60 mcg), Ages 50-59 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 16 (Second Product Administration) | 484 titer |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 18 (14 Days After Second Product Administration) | 894 titer |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 0 (Baseline, Pre-Administration) | 283 titer |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 2 (14 Days After First Product Administration) | 741 titer |
| Group 2D: H1ssF_3928 (60 mcg), Ages 60-70 Years | Pseudoviral Neutralization Assay Geometric Mean Titer (GMT) Against Homologous A/New Caledonia/20/1999 Virus (H1N1) Following the Completion of Each Vaccination Regimen | Week 16 (Second Product Administration) | 792 titer |