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Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults

A Phase I/II Observer-blind, Randomized, Multi-center Trial to Evaluate the Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System (Referred to as Q-Pan H5N8), Given as a Two-dose Series to Adults 18 to 64 Years of Age and 65 Years of Age and Older

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05975840
Enrollment
518
Registered
2023-08-04
Start date
2023-08-03
Completion date
2024-09-19
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Human

Keywords

Influenza, Safety, Immunogenicity

Brief summary

The purpose of this study is to assess the safety and immunogenicity of different formulations of monovalent Influenza A/Astrakhan/3212/2020-like virus vaccine with AS03 adjuvant system in adults greater than or equal to (\>=)18 years of age.

Interventions

BIOLOGICALFLU Q-PAN H5N8 375_B

Participants received 2 doses of 375\_B vaccine formulation by intramuscular injection in the non-dominant arm.

BIOLOGICALFLU Q-PAN H5N8 375_A

Participants received 2 doses of 375\_A vaccine formulation by intramuscular injection in the non-dominant arm.

BIOLOGICALFLU Q-PAN H5N8 750_B

Participants received 2 doses of 750\_B vaccine formulation by intramuscular injection in the non-dominant arm.

BIOLOGICALFLU Q-PAN H5N8 750_A

Participants received 2 doses of 750\_A vaccine formulation by intramuscular injection in the non-dominant arm.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

This study will be observer blind.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Medically stable participants as established by medical history and clinical examination before entering into the study. * A male or female \>=18 years of age at the time of signing consent form. * Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study specific procedure. * Female participants of childbearing potential or non-childbearing potential may be enrolled in the study if specific criteria are met.

Exclusion criteria

* Current diagnosis or history of autoimmune disorder(s) except hypothyroidism due to Hashimoto's thyroiditis. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Clinically significant acute or chronic pulmonary, cardiovascular, hepatic, or renal disease that appears uncontrolled or untreated, as determined by history or physical examination. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history, physical examination, or abnormalities in screening blood tests. * Recurrent history of or uncontrolled neurological disorders or seizures. * History of Guillain-Barré syndrome. * Diagnosed with cancer, or treatment for cancer within 3 years. * Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible. * Persons with a history of histologically confirmed basal cell carcinoma of the skin successfully treated with local excision only, are accepted and are eligible, but other histologic types of skin cancer are exclusionary. * Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible. * Documented human immunodeficiency virus-positive participants. * Bedridden participants. * Personal or family history of narcolepsy. * Food and Drug Administration (FDA) toxicity Grade 2, or greater, laboratory tests at Screening. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. * Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the entire study period. * Use of public health emergency vaccines like coronavirus disease 2019 (COVID-19), Monkey pox (mpox) etc. These can be given at any time, but there should a gap of 2 - weeks before a dose of study vaccine can be given. * Use of any licensed vaccines: prior to receipt of the study vaccine and continuing up to 3 weeks after receiving the dose 2 of study vaccine. * Administration of long-acting immune-modifying drugs at any time during the study period. * Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine or planned administration during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine dose and through the entire study period. For corticosteroids, this will mean prednisone equivalent \>=20 milligrams/day for 14 days or a total of \>=280 mg of prednisone equivalent dose in any 14-day period. Inhaled and topical steroids are allowed. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after completion of the vaccination series. * History of/or current drug/alcohol abuse. * Any study personnel or their immediate dependents, family, or household member. * Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)Day 1 to 6 months post dose 2 (administered on Day 22)—
Number of Participants Reporting Unsolicited AEs Following Dose 221 days (Day 22 to Day 43) following dose 2An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Number of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 121 days (Day 1 to Day 22) following dose 1MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).
Number of Participants Reporting Unsolicited MAEs Following Dose 221 days (Day 22 to Day 43) following dose 2—
Number of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)Up to 6 months post dose 2 (administered on Day 22)—
Number of Participants Reporting Serious Adverse Events (SAEs) up to Day 43From Day 1 to Day 43An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.
Number of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)Day 1 to 6 months post dose 2 (administered on Day 22)—
Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 43From Day 1 to Day 43pIMDs are defined a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Hemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8At Day 43Antibody titers were presented as geometric mean titers (GMTs).
Geometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N8At Day 43The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Number of Seroprotected (SP) Participants for HI Antibody TitersAt Day 43Seroprotection rate is defined as the number of participants with HI titer value greater than or equal to (\>=) 1:40 which is considered as indicating protection.
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 17 days (Day 1 to Day 7) following dose 1Solicited administration site events included pain, redness and swelling.
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 27 days (Day 22 to Day 28) following dose 2Solicited administration site events included pain, redness and swelling.
Number of Participants Reporting Each Solicited Systemic Event Following Dose 17 days (Day 1 to Day 7) following dose 1Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature \>=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Number of Participants Reporting Each Solicited Systemic Event Following Dose 27 days (Day 22 to Day 28) following dose 2Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature \>=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 17 days (Day 1 to Day 7) following dose 1Hemoglobin, white blood cells (WBC) increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 27 days (Day 22 to Day 28) following dose 2Hemoglobin, WBC increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 17 days (Day 1 to Day 7) following dose 1Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin and blood urea nitrogen (BUN) were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 27 days (Day 22 to Day 28) following dose 2Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, ALT, AST, alkaline phosphatase, total bilirubin and BUN were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).
Number of Participants Reporting Unsolicited AEs Following Dose 121 days (Day 1 to Day 22) following dose 1An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

Secondary

MeasureTime frameDescription
GMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8At Day 22, and 6 months post dose 2 (administered on Day 22)The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
Number of Seroprotected Participants for HI Antibody TitersAt Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)Seroprotection rate is defined as the number of participants with HI titer value \>= 1:40 which is considered as indicating protection.
Number of Seroconverted Participants for HI Antibody TitersAt Day 22, Day 43 and 6 months post dose 2 (administered on Day 22)HI seroconversion is defined as a post-vaccination titer \>=1:40 in the serum of participants with pre-vaccination titer below 1:10 or as a \>=4-fold rise in post-vaccination HI titer with pre-vaccination titer \>=1:10.
Microneutralization (MN) Antibody Titers for a Subset of ParticipantsAt Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)Microneutralization testing was performed on 50% of the participants, randomly selected and equally distributed across the different age groups.
Number of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsAt Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)A seropositive participant is a participant whose antibody titer is greater than or equal to the assay cut-off value of 1:40.
Number of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsAt Day 22, Day 43, and 6 months post dose 2 (administered on Day 22)MN VR is defined as titer \>=4x LLOQ for participants with pre-vaccination titer below LLOQ or a \>=4 -fold increase from pre-vaccination titer for participants with pre-vaccination titer \>=LLOQ.
HI Antibody Titers Against Vaccine-homologous H5N8Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)Antibody titers were presented as geometric mean titers (GMTs).

Countries

United States

Participant flow

Participants by arm

ArmCount
Age Group 18-64: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.
66
Age Group 18-64: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.
65
Age Group 18-64: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.
64
Age Group 18-64: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
63
Age Group >=65: FLU Q-PAN H5N8 375_B
Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.
66
Age Group >=65: FLU Q-PAN H5N8 375_A
Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.
64
Age Group >=65: FLU Q-PAN H5N8 750_B
Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.
66
Age Group >=65: FLU Q-PAN H5N8 750_A
Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
64
Total518

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007
Overall StudyAdverse Event00010000
Overall StudyDeath01000001
Overall StudyLost to Follow-up36314124
Overall StudyMigrated/moved from the study area10000000
Overall StudyOther10001000
Overall StudyProtocol Violation01000000
Overall StudyWithdrawal by Subject05220221

Baseline characteristics

CharacteristicAge Group 18-64: FLU Q-PAN H5N8 375_BAge Group 18-64: FLU Q-PAN H5N8 375_AAge Group 18-64: FLU Q-PAN H5N8 750_BAge Group 18-64: FLU Q-PAN H5N8 750_ATotalAge Group >=65: FLU Q-PAN H5N8 375_BAge Group >=65: FLU Q-PAN H5N8 375_AAge Group >=65: FLU Q-PAN H5N8 750_BAge Group >=65: FLU Q-PAN H5N8 750_A
Age, Continuous
18-64 Years of age
42.5 Years
STANDARD_DEVIATION 13.5
42.3 Years
STANDARD_DEVIATION 12.3
40.7 Years
STANDARD_DEVIATION 12.8
44.0 Years
STANDARD_DEVIATION 13.4
42.4 Years
STANDARD_DEVIATION 13
————
Age, Continuous
>=65 Years of age
————71.5 Years
STANDARD_DEVIATION 5.1
70.9 Years
STANDARD_DEVIATION 4.7
71.9 Years
STANDARD_DEVIATION 5.4
72.1 Years
STANDARD_DEVIATION 5.2
71.0 Years
STANDARD_DEVIATION 5.2
Race/Ethnicity, Customized
Other, combined to maintain patient confidentiality
32 Participants24 Participants25 Participants25 Participants163 Participants12 Participants14 Participants14 Participants17 Participants
Race/Ethnicity, Customized
White
34 Participants41 Participants39 Participants38 Participants355 Participants54 Participants50 Participants52 Participants47 Participants
Sex: Female, Male
Female
34 Participants24 Participants29 Participants40 Participants271 Participants35 Participants32 Participants41 Participants36 Participants
Sex: Female, Male
Male
32 Participants41 Participants35 Participants23 Participants247 Participants31 Participants32 Participants25 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
0 / 661 / 650 / 640 / 630 / 660 / 640 / 661 / 64
other
Total, other adverse events
50 / 6640 / 6540 / 6450 / 6339 / 6644 / 6434 / 6641 / 64
serious
Total, serious adverse events
1 / 661 / 650 / 642 / 632 / 662 / 642 / 662 / 64

Outcome results

Primary

Geometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N8

The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

Time frame: At Day 43

Population: PPS population. Only those participants with data available at the specified timepoint have been analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)
Age Group 18-64: FLU Q-PAN H5N8 375_BGeometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N821.7 Ratio
Age Group 18-64: FLU Q-PAN H5N8 375_AGeometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N833.0 Ratio
Age Group 18-64: FLU Q-PAN H5N8 750_BGeometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N823.7 Ratio
Age Group 18-64: FLU Q-PAN H5N8 750_AGeometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N833.1 Ratio
Age Group >=65: FLU Q-PAN H5N8 375_BGeometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N811.7 Ratio
Age Group >=65: FLU Q-PAN H5N8 375_AGeometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N814.3 Ratio
Age Group >=65: FLU Q-PAN H5N8 750_BGeometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N812.8 Ratio
Age Group >=65: FLU Q-PAN H5N8 750_AGeometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N819.5 Ratio
Primary

Hemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: At Day 43

Population: Analysis was performed on the Per-protocol set (PPS) which included all eligible participants who received the 2 doses of study intervention as per protocol, had Day 1 and Day 43 post dose anti-HI immunogenicity results as per blood draw interval at Day 43. Only those participants with data available at the specified timepoint have been analyzed.

ArmMeasureValue (GEOMETRIC_MEAN)
Age Group 18-64: FLU Q-PAN H5N8 375_BHemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8117.5 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_AHemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8175.2 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_BHemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8121.8 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_AHemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8176.6 Titer
Age Group >=65: FLU Q-PAN H5N8 375_BHemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N880.6 Titer
Age Group >=65: FLU Q-PAN H5N8 375_AHemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8110.2 Titer
Age Group >=65: FLU Q-PAN H5N8 750_BHemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N884.0 Titer
Age Group >=65: FLU Q-PAN H5N8 750_AHemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8129.3 Titer
Primary

Number of Participants Reporting Each Solicited Administration Site Event Following Dose 1

Solicited administration site events included pain, redness and swelling.

Time frame: 7 days (Day 1 to Day 7) following dose 1

Population: The analysis was performed on the Diary Set for dose 1 (DS1) which included participants who received a study intervention and provided information on at least 1 solicited adverse event (AE) on at least 1 day.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Pain39 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Swelling2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Redness3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Swelling0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Redness0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Pain34 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Swelling2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Pain27 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Redness2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Pain38 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Redness2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Swelling2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Redness0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Pain23 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Swelling2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Redness1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Pain22 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Swelling1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Redness0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Pain14 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Swelling0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Pain29 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Redness4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 1Swelling5 Participants
Primary

Number of Participants Reporting Each Solicited Administration Site Event Following Dose 2

Solicited administration site events included pain, redness and swelling.

Time frame: 7 days (Day 22 to Day 28) following dose 2

Population: Analysis was performed on the DS2 which included participants who received a study intervention and provided information on at least 1 solicited AE on at least 1 day.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Swelling3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Pain31 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Redness1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Redness0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Swelling0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Pain19 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Redness2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Swelling1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Pain21 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Swelling1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Pain24 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Redness2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Redness0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Pain17 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Swelling0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Redness1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Swelling1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Pain14 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Redness0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Pain12 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Swelling0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Swelling2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Pain15 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Administration Site Event Following Dose 2Redness3 Participants
Primary

Number of Participants Reporting Each Solicited Systemic Event Following Dose 1

Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature \>=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).

Time frame: 7 days (Day 1 to Day 7) following dose 1

Population: DS1 population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Muscle ache23 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Abdominal pain6 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Headache19 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Vomiting1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Nausea11 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fatigue25 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Sweating10 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Shivering (chills)6 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fever2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Diarrhea7 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Joint pain12 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fatigue18 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Diarrhea4 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Vomiting0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Headache12 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Abdominal pain3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Joint pain9 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Shivering (chills)7 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fever0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Muscle ache22 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Sweating7 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Nausea6 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Sweating3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Vomiting0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fever0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Headache10 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Abdominal pain2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Muscle ache15 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Joint pain3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Diarrhea6 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Shivering (chills)1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Nausea4 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fatigue15 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Joint pain9 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Sweating7 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Diarrhea5 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Vomiting1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Nausea7 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Headache15 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Muscle ache26 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fatigue20 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fever0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Shivering (chills)5 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Abdominal pain4 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Shivering (chills)5 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Abdominal pain7 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Diarrhea2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fatigue9 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Joint pain2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fever0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Vomiting0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Muscle ache9 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Nausea5 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Sweating6 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Headache9 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Abdominal pain3 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fatigue13 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fever0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Headache12 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Muscle ache12 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Joint pain9 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Shivering (chills)2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Sweating2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Nausea2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Vomiting0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Diarrhea1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Sweating2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Muscle ache8 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fatigue6 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Diarrhea4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Nausea5 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Shivering (chills)0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Headache5 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Abdominal pain5 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fever0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Joint pain4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Vomiting0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Vomiting1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Nausea4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Abdominal pain4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Sweating4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Shivering (chills)4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Joint pain6 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Muscle ache16 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Diarrhea3 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Headache12 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fever1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 1Fatigue12 Participants
Primary

Number of Participants Reporting Each Solicited Systemic Event Following Dose 2

Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature \>=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).

Time frame: 7 days (Day 22 to Day 28) following dose 2

Population: DS2 population

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Joint pain8 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Nausea2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Shivering (chills)3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Sweating5 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fever0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Abdominal pain2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fatigue18 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Headache19 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Diarrhea6 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Muscle ache17 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Vomiting1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Joint pain6 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Headache6 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Abdominal pain2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fatigue9 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Shivering (chills)2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Nausea2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Sweating3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Muscle ache10 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Vomiting0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fever2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Diarrhea3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fever0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Shivering (chills)3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Abdominal pain2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Headache4 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Diarrhea3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Nausea0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Joint pain3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Sweating3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Vomiting0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Muscle ache10 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fatigue10 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Diarrhea3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fatigue11 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fever1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Headache10 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Muscle ache15 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Joint pain6 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Sweating5 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Nausea6 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Vomiting3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Abdominal pain6 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Shivering (chills)3 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Muscle ache6 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Headache5 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Joint pain3 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Vomiting1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fatigue5 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fever0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Abdominal pain1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Nausea1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Sweating4 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Diarrhea1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Shivering (chills)1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fever0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Nausea3 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Muscle ache7 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fatigue12 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Vomiting0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Headache4 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Diarrhea1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Sweating2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Abdominal pain1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Shivering (chills)1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Joint pain1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Muscle ache3 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fever0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Joint pain2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Nausea1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Shivering (chills)1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Vomiting0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fatigue4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Headache4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Sweating0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Abdominal pain1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Diarrhea2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fever1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Joint pain4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Diarrhea1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Abdominal pain1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Muscle ache7 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Sweating1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Fatigue8 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Vomiting0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Shivering (chills)1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Headache5 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Each Solicited Systemic Event Following Dose 2Nausea2 Participants
Primary

Number of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)

Time frame: Day 1 to 6 months post dose 2 (administered on Day 22)

Population: The analysis was performed on the Total ES which included participants who received a study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)0 Participants
Primary

Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 43

pIMDs are defined a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Time frame: From Day 1 to Day 43

Population: The analysis was performed on the Total ES which included participants who received a study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 430 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 430 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 430 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 430 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 430 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 430 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 430 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 430 Participants
Primary

Number of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)

Time frame: Day 1 to 6 months post dose 2 (administered on Day 22)

Population: The analysis was performed on the Total ES which included participants who received a study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)2 Participants
Primary

Number of Participants Reporting Serious Adverse Events (SAEs) up to Day 43

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.

Time frame: From Day 1 to Day 43

Population: The analysis was performed on the Total ES which included participants who received a study intervention.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Serious Adverse Events (SAEs) up to Day 431 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Serious Adverse Events (SAEs) up to Day 431 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Serious Adverse Events (SAEs) up to Day 430 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Serious Adverse Events (SAEs) up to Day 432 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Serious Adverse Events (SAEs) up to Day 430 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Serious Adverse Events (SAEs) up to Day 430 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Serious Adverse Events (SAEs) up to Day 431 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Serious Adverse Events (SAEs) up to Day 431 Participants
Primary

Number of Participants Reporting Unsolicited AEs Following Dose 1

An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

Time frame: 21 days (Day 1 to Day 22) following dose 1

Population: Analysis was performed on the total ES population that reported unsolicited AEs for dose 1 at specified timepoints.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Unsolicited AEs Following Dose 14 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Unsolicited AEs Following Dose 16 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Unsolicited AEs Following Dose 17 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Unsolicited AEs Following Dose 17 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Unsolicited AEs Following Dose 14 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Unsolicited AEs Following Dose 15 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Unsolicited AEs Following Dose 15 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Unsolicited AEs Following Dose 18 Participants
Primary

Number of Participants Reporting Unsolicited AEs Following Dose 2

An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

Time frame: 21 days (Day 22 to Day 43) following dose 2

Population: Analysis was performed on the total ES population that reported unsolicited AEs for dose 2 at specified timepoints.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Unsolicited AEs Following Dose 23 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Unsolicited AEs Following Dose 24 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Unsolicited AEs Following Dose 22 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Unsolicited AEs Following Dose 23 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Unsolicited AEs Following Dose 26 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Unsolicited AEs Following Dose 23 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Unsolicited AEs Following Dose 23 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Unsolicited AEs Following Dose 21 Participants
Primary

Number of Participants Reporting Unsolicited MAEs Following Dose 2

Time frame: 21 days (Day 22 to Day 43) following dose 2

Population: Analysis was performed on the total ES population that reported unsolicited MAEs for dose 2 at specified timepoints.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Unsolicited MAEs Following Dose 22 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Unsolicited MAEs Following Dose 21 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Unsolicited MAEs Following Dose 21 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Unsolicited MAEs Following Dose 22 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Unsolicited MAEs Following Dose 21 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Unsolicited MAEs Following Dose 20 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Unsolicited MAEs Following Dose 22 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Unsolicited MAEs Following Dose 20 Participants
Primary

Number of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)

Time frame: Up to 6 months post dose 2 (administered on Day 22)

Population: Analysis was performed on the total ES population that reported unsolicited MAEs for dose 2 at specified timepoints.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)4 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)6 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)6 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)8 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)6 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)6 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)11 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)8 Participants
Primary

Number of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 1

MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).

Time frame: 21 days (Day 1 to Day 22) following dose 1

Population: Analysis was performed on the total ES population that reported unsolicited MAEs for dose 1 at specified timepoints.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 11 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 13 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 13 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 13 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 12 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 11 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 11 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 13 Participants
Primary

Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1

Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin and blood urea nitrogen (BUN) were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

Time frame: 7 days (Day 1 to Day 7) following dose 1

Population: Analysis was performed on the Exposed set for dose 1 (ES1), which included participants who received a study intervention and for whom blood samples were collected and analyzed for the safety laboratory tests, at the specified timepoint.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Decrease2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1AST0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Creatinine0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Alkaline Phosphatase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1BUN0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Total Bilirubin0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Decrease1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1ALT0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1BUN1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Alkaline Phosphatase3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Creatinine0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Decrease3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1ALT1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1AST1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Total Bilirubin0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Decrease1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1AST2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Increase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Increase6 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1BUN0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Total Bilirubin1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Decrease4 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Alkaline Phosphatase2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Creatinine0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1ALT1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Decrease3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Creatinine0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1BUN0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1ALT1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Decrease1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1AST0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Total Bilirubin0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Increase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Alkaline Phosphatase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Decrease1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Increase0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Decrease4 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Increase5 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Decrease0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1ALT2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1AST0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Total Bilirubin0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Creatinine1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Alkaline Phosphatase4 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1BUN2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Decrease4 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Decrease0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Creatinine1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Alkaline Phosphatase3 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1ALT1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1BUN5 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1AST0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Increase7 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Increase2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Total Bilirubin0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Decrease1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1AST3 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Decrease5 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Increase1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1ALT0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Total Bilirubin0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1BUN4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Alkaline Phosphatase2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Increase2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Creatinine0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1ALT2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Creatinine0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1AST4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Decrease4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Potassium Increase5 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Decrease4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Total Bilirubin0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Sodium Increase0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1BUN2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1Alkaline Phosphatase3 Participants
Primary

Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2

Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, ALT, AST, alkaline phosphatase, total bilirubin and BUN were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

Time frame: 7 days (Day 22 to Day 28) following dose 2

Population: Analysis was performed on the Exposed set for dose 2 (ES2), which included participants who received a study intervention and for whom blood samples were collected and analyzed for the safety laboratory tests, at the specified timepoint.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Increase2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Total Bilirubin0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Decrease0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Decrease1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2ALT1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Alkaline Phosphatase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2AST1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2BUN1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Increase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Creatinine0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Creatinine1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2ALT3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2BUN1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Increase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Total Bilirubin0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Decrease2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Alkaline Phosphatase3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2AST0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Decrease0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2AST1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Creatinine0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Decrease0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Alkaline Phosphatase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Total Bilirubin0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Increase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Decrease1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2BUN0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2ALT1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Total Bilirubin0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2ALT1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Creatinine0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2AST1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Decrease0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Alkaline Phosphatase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2BUN0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Decrease2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Increase0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Increase1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Decrease1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Increase4 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Decrease0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Creatinine0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2ALT0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2AST0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Alkaline Phosphatase3 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Total Bilirubin0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2BUN1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Increase1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Increase1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Decrease2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Decrease0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Total Bilirubin0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Alkaline Phosphatase2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2ALT0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2BUN3 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2AST1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Creatinine1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Decrease1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2ALT0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Increase4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2AST4 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Decrease2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Alkaline Phosphatase2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Increase0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Total Bilirubin0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Creatinine0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2BUN1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2AST0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2BUN5 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Increase3 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2ALT0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Total Bilirubin0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Creatinine0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Alkaline Phosphatase3 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Decrease1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Sodium Increase0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2Potassium Decrease1 Participants
Primary

Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1

Hemoglobin, white blood cells (WBC) increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

Time frame: 7 days (Day 1 to Day 7) following dose 1

Population: Analysis was performed on the Exposed set for dose 1 (ES1), which included participants who received a study intervention and for whom blood samples were collected and analyzed for the safety laboratory tests, at the specified timepoint.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Decrease2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Neutrophils Absolute3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Hemoglobin2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Lymphocytes Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Eosinophils Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Platelets0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Platelets0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Decrease2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Lymphocytes Absolute1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Eosinophils Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Hemoglobin5 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Neutrophils Absolute1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Hemoglobin1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Eosinophils Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Neutrophils Absolute2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Increase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Decrease0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Lymphocytes Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Platelets0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Decrease3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Hemoglobin6 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Neutrophils Absolute3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Lymphocytes Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Increase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Eosinophils Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Platelets0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Lymphocytes Absolute0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Eosinophils Absolute0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Decrease0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Platelets1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Hemoglobin7 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Neutrophils Absolute0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Increase1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Lymphocytes Absolute5 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Hemoglobin6 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Platelets0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Decrease1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Increase2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Eosinophils Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Neutrophils Absolute2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Neutrophils Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Eosinophils Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Platelets0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Decrease1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Lymphocytes Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Increase0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Hemoglobin7 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Eosinophils Absolute0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Hemoglobin7 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Increase1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1WBC Decrease0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Platelets1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Neutrophils Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1Lymphocytes Absolute0 Participants
Primary

Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2

Hemoglobin, WBC increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

Time frame: 7 days (Day 22 to Day 28) following dose 2

Population: Analysis was performed on the Exposed set for dose 2 (ES2), which included participants who received a study intervention and for whom blood samples were collected and analyzed for the safety laboratory tests, at the specified timepoint.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Hemoglobin5 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Lymphocytes Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Increase2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Neutrophils Absolute2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Eosinophils Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Decrease1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Platelets0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Decrease0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Eosinophils Absolute1 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Platelets0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Increase2 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Neutrophils Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Hemoglobin3 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Lymphocytes Absolute1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Hemoglobin3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Lymphocytes Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Increase1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Eosinophils Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Decrease0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Neutrophils Absolute3 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Platelets1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Decrease0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Neutrophils Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Lymphocytes Absolute1 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Eosinophils Absolute0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Hemoglobin2 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Increase0 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Platelets0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Neutrophils Absolute0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Lymphocytes Absolute0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Hemoglobin2 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Decrease0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Platelets0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Eosinophils Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Increase1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Hemoglobin4 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Decrease0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Lymphocytes Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Neutrophils Absolute0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Eosinophils Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Platelets0 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Increase1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Lymphocytes Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Neutrophils Absolute0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Hemoglobin3 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Increase0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Eosinophils Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Platelets0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Decrease0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Neutrophils Absolute0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Eosinophils Absolute0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Platelets0 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Increase2 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2WBC Decrease1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Lymphocytes Absolute1 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2Hemoglobin4 Participants
Primary

Number of Seroprotected (SP) Participants for HI Antibody Titers

Seroprotection rate is defined as the number of participants with HI titer value greater than or equal to (\>=) 1:40 which is considered as indicating protection.

Time frame: At Day 43

Population: PPS population. Only those participants with data available at the specified timepoint have been analyzed.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Seroprotected (SP) Participants for HI Antibody Titers56 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Seroprotected (SP) Participants for HI Antibody Titers45 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Seroprotected (SP) Participants for HI Antibody Titers46 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Seroprotected (SP) Participants for HI Antibody Titers49 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Seroprotected (SP) Participants for HI Antibody Titers43 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Seroprotected (SP) Participants for HI Antibody Titers37 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Seroprotected (SP) Participants for HI Antibody Titers41 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Seroprotected (SP) Participants for HI Antibody Titers41 Participants
Secondary

GMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8

The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

Time frame: At Day 22, and 6 months post dose 2 (administered on Day 22)

Population: PPS population. Only those participants with data available at the specified time point have been analyzed.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Age Group 18-64: FLU Q-PAN H5N8 375_BGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N86 months post dose 24.3 Ratio
Age Group 18-64: FLU Q-PAN H5N8 375_BGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8Day 229.1 Ratio
Age Group 18-64: FLU Q-PAN H5N8 375_AGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8Day 2210.2 Ratio
Age Group 18-64: FLU Q-PAN H5N8 375_AGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N86 months post dose 25.0 Ratio
Age Group 18-64: FLU Q-PAN H5N8 750_BGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8Day 2210.2 Ratio
Age Group 18-64: FLU Q-PAN H5N8 750_BGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N86 months post dose 25.1 Ratio
Age Group 18-64: FLU Q-PAN H5N8 750_AGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8Day 2210.6 Ratio
Age Group 18-64: FLU Q-PAN H5N8 750_AGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N86 months post dose 25.8 Ratio
Age Group >=65: FLU Q-PAN H5N8 375_BGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N86 months post dose 23.6 Ratio
Age Group >=65: FLU Q-PAN H5N8 375_BGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8Day 225.8 Ratio
Age Group >=65: FLU Q-PAN H5N8 375_AGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N86 months post dose 23.9 Ratio
Age Group >=65: FLU Q-PAN H5N8 375_AGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8Day 225.1 Ratio
Age Group >=65: FLU Q-PAN H5N8 750_BGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8Day 226.9 Ratio
Age Group >=65: FLU Q-PAN H5N8 750_BGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N86 months post dose 23.8 Ratio
Age Group >=65: FLU Q-PAN H5N8 750_AGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8Day 228.3 Ratio
Age Group >=65: FLU Q-PAN H5N8 750_AGMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N86 months post dose 24.3 Ratio
Secondary

HI Antibody Titers Against Vaccine-homologous H5N8

Antibody titers were presented as geometric mean titers (GMTs).

Time frame: Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

Population: PPS population. Only those participants with data available at the specified time points have been analyzed.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Age Group 18-64: FLU Q-PAN H5N8 375_BHI Antibody Titers Against Vaccine-homologous H5N86 months post dose 223.7 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_BHI Antibody Titers Against Vaccine-homologous H5N8Day 2249.1 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_BHI Antibody Titers Against Vaccine-homologous H5N8Day 15.4 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_AHI Antibody Titers Against Vaccine-homologous H5N8Day 2254.2 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_AHI Antibody Titers Against Vaccine-homologous H5N8Day 15.2 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_AHI Antibody Titers Against Vaccine-homologous H5N86 months post dose 226.4 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_BHI Antibody Titers Against Vaccine-homologous H5N8Day 2252.7 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_BHI Antibody Titers Against Vaccine-homologous H5N8Day 15.2 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_BHI Antibody Titers Against Vaccine-homologous H5N86 months post dose 226.5 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_AHI Antibody Titers Against Vaccine-homologous H5N8Day 15.4 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_AHI Antibody Titers Against Vaccine-homologous H5N8Day 2256.5 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_AHI Antibody Titers Against Vaccine-homologous H5N86 months post dose 230.8 Titer
Age Group >=65: FLU Q-PAN H5N8 375_BHI Antibody Titers Against Vaccine-homologous H5N8Day 16.7 Titer
Age Group >=65: FLU Q-PAN H5N8 375_BHI Antibody Titers Against Vaccine-homologous H5N86 months post dose 225.5 Titer
Age Group >=65: FLU Q-PAN H5N8 375_BHI Antibody Titers Against Vaccine-homologous H5N8Day 2240.2 Titer
Age Group >=65: FLU Q-PAN H5N8 375_AHI Antibody Titers Against Vaccine-homologous H5N8Day 17.7 Titer
Age Group >=65: FLU Q-PAN H5N8 375_AHI Antibody Titers Against Vaccine-homologous H5N8Day 2239.7 Titer
Age Group >=65: FLU Q-PAN H5N8 375_AHI Antibody Titers Against Vaccine-homologous H5N86 months post dose 228.5 Titer
Age Group >=65: FLU Q-PAN H5N8 750_BHI Antibody Titers Against Vaccine-homologous H5N8Day 2244.7 Titer
Age Group >=65: FLU Q-PAN H5N8 750_BHI Antibody Titers Against Vaccine-homologous H5N8Day 16.4 Titer
Age Group >=65: FLU Q-PAN H5N8 750_BHI Antibody Titers Against Vaccine-homologous H5N86 months post dose 225.3 Titer
Age Group >=65: FLU Q-PAN H5N8 750_AHI Antibody Titers Against Vaccine-homologous H5N8Day 16.6 Titer
Age Group >=65: FLU Q-PAN H5N8 750_AHI Antibody Titers Against Vaccine-homologous H5N86 months post dose 229.0 Titer
Age Group >=65: FLU Q-PAN H5N8 750_AHI Antibody Titers Against Vaccine-homologous H5N8Day 2254.5 Titer
Secondary

Microneutralization (MN) Antibody Titers for a Subset of Participants

Microneutralization testing was performed on 50% of the participants, randomly selected and equally distributed across the different age groups.

Time frame: At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

Population: PPS population subset for MN testing. Only those participants with data available at the specified time points have been analyzed.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Age Group 18-64: FLU Q-PAN H5N8 375_BMicroneutralization (MN) Antibody Titers for a Subset of Participants6 months post dose 26.4 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_BMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 15.0 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_BMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 227.0 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_AMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 227.8 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_AMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 15.0 Titer
Age Group 18-64: FLU Q-PAN H5N8 375_AMicroneutralization (MN) Antibody Titers for a Subset of Participants6 months post dose 26.9 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_BMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 228.1 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_BMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 15.0 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_BMicroneutralization (MN) Antibody Titers for a Subset of Participants6 months post dose 27.0 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_AMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 15.1 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_AMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 228.7 Titer
Age Group 18-64: FLU Q-PAN H5N8 750_AMicroneutralization (MN) Antibody Titers for a Subset of Participants6 months post dose 26.9 Titer
Age Group >=65: FLU Q-PAN H5N8 375_BMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 15.0 Titer
Age Group >=65: FLU Q-PAN H5N8 375_BMicroneutralization (MN) Antibody Titers for a Subset of Participants6 months post dose 26.5 Titer
Age Group >=65: FLU Q-PAN H5N8 375_BMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 226.4 Titer
Age Group >=65: FLU Q-PAN H5N8 375_AMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 15.2 Titer
Age Group >=65: FLU Q-PAN H5N8 375_AMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 225.8 Titer
Age Group >=65: FLU Q-PAN H5N8 375_AMicroneutralization (MN) Antibody Titers for a Subset of Participants6 months post dose 26.2 Titer
Age Group >=65: FLU Q-PAN H5N8 750_BMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 226.7 Titer
Age Group >=65: FLU Q-PAN H5N8 750_BMicroneutralization (MN) Antibody Titers for a Subset of Participants6 months post dose 26.1 Titer
Age Group >=65: FLU Q-PAN H5N8 750_BMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 15.1 Titer
Age Group >=65: FLU Q-PAN H5N8 750_AMicroneutralization (MN) Antibody Titers for a Subset of Participants6 months post dose 29.1 Titer
Age Group >=65: FLU Q-PAN H5N8 750_AMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 15.0 Titer
Age Group >=65: FLU Q-PAN H5N8 750_AMicroneutralization (MN) Antibody Titers for a Subset of ParticipantsDay 227.0 Titer
Secondary

Number of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants

MN VR is defined as titer \>=4x LLOQ for participants with pre-vaccination titer below LLOQ or a \>=4 -fold increase from pre-vaccination titer for participants with pre-vaccination titer \>=LLOQ.

Time frame: At Day 22, Day 43, and 6 months post dose 2 (administered on Day 22)

Population: PPS population subset for MN testing. Only those participants with data available at the specified time points have been analyzed.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 4310 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants6 months post dose 20 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 220 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 222 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants6 months post dose 20 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 4312 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 221 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 4310 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants6 months post dose 20 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants6 months post dose 20 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 221 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 4313 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants6 months post dose 20 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 221 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 432 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants6 months post dose 20 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 220 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 436 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants6 months post dose 21 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 220 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 432 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants6 months post dose 21 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 439 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of ParticipantsDay 221 Participants
Secondary

Number of Seroconverted Participants for HI Antibody Titers

HI seroconversion is defined as a post-vaccination titer \>=1:40 in the serum of participants with pre-vaccination titer below 1:10 or as a \>=4-fold rise in post-vaccination HI titer with pre-vaccination titer \>=1:10.

Time frame: At Day 22, Day 43 and 6 months post dose 2 (administered on Day 22)

Population: PPS population. Only those participants with data available at the specified timepoint have been analyzed.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Seroconverted Participants for HI Antibody TitersDay 2240 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Seroconverted Participants for HI Antibody Titers6 months post dose 213 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Seroconverted Participants for HI Antibody TitersDay 4355 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Seroconverted Participants for HI Antibody TitersDay 4345 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Seroconverted Participants for HI Antibody Titers6 months post dose 220 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Seroconverted Participants for HI Antibody TitersDay 2239 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Seroconverted Participants for HI Antibody TitersDay 4346 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Seroconverted Participants for HI Antibody TitersDay 2239 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Seroconverted Participants for HI Antibody Titers6 months post dose 217 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Seroconverted Participants for HI Antibody TitersDay 2242 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Seroconverted Participants for HI Antibody TitersDay 4349 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Seroconverted Participants for HI Antibody Titers6 months post dose 224 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Seroconverted Participants for HI Antibody Titers6 months post dose 212 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Seroconverted Participants for HI Antibody TitersDay 2221 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Seroconverted Participants for HI Antibody TitersDay 4339 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Seroconverted Participants for HI Antibody TitersDay 4336 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Seroconverted Participants for HI Antibody TitersDay 2221 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Seroconverted Participants for HI Antibody Titers6 months post dose 214 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Seroconverted Participants for HI Antibody TitersDay 2229 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Seroconverted Participants for HI Antibody TitersDay 4340 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Seroconverted Participants for HI Antibody Titers6 months post dose 212 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Seroconverted Participants for HI Antibody Titers6 months post dose 220 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Seroconverted Participants for HI Antibody TitersDay 2231 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Seroconverted Participants for HI Antibody TitersDay 4340 Participants
Secondary

Number of Seropositive Participants for MN Antibody Titers for a Subset of Participants

A seropositive participant is a participant whose antibody titer is greater than or equal to the assay cut-off value of 1:40.

Time frame: At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

Population: PPS population subset for MN testing. Only those participants with data available at the specified time points have been analyzed.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of Participants6 months post dose 28 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 2210 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 10 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of Participants6 months post dose 28 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 10 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 2210 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of Participants6 months post dose 28 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 10 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 2213 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 2214 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of Participants6 months post dose 28 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 11 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of Participants6 months post dose 28 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 10 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 225 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 11 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of Participants6 months post dose 24 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 223 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 228 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 11 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Seropositive Participants for MN Antibody Titers for a Subset of Participants6 months post dose 24 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 10 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of ParticipantsDay 228 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Seropositive Participants for MN Antibody Titers for a Subset of Participants6 months post dose 210 Participants
Secondary

Number of Seroprotected Participants for HI Antibody Titers

Seroprotection rate is defined as the number of participants with HI titer value \>= 1:40 which is considered as indicating protection.

Time frame: At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

Population: PPS population. Only those participants with data available at the specified timepoint have been analyzed.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Seroprotected Participants for HI Antibody TitersDay 10 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Seroprotected Participants for HI Antibody Titers6 months post dose 214 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_BNumber of Seroprotected Participants for HI Antibody TitersDay 2240 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Seroprotected Participants for HI Antibody TitersDay 2240 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Seroprotected Participants for HI Antibody TitersDay 10 Participants
Age Group 18-64: FLU Q-PAN H5N8 375_ANumber of Seroprotected Participants for HI Antibody Titers6 months post dose 220 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Seroprotected Participants for HI Antibody TitersDay 2239 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Seroprotected Participants for HI Antibody Titers6 months post dose 217 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_BNumber of Seroprotected Participants for HI Antibody TitersDay 10 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Seroprotected Participants for HI Antibody TitersDay 11 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Seroprotected Participants for HI Antibody Titers6 months post dose 225 Participants
Age Group 18-64: FLU Q-PAN H5N8 750_ANumber of Seroprotected Participants for HI Antibody TitersDay 2243 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Seroprotected Participants for HI Antibody TitersDay 2225 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Seroprotected Participants for HI Antibody TitersDay 11 Participants
Age Group >=65: FLU Q-PAN H5N8 375_BNumber of Seroprotected Participants for HI Antibody Titers6 months post dose 214 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Seroprotected Participants for HI Antibody TitersDay 2224 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Seroprotected Participants for HI Antibody TitersDay 11 Participants
Age Group >=65: FLU Q-PAN H5N8 375_ANumber of Seroprotected Participants for HI Antibody Titers6 months post dose 217 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Seroprotected Participants for HI Antibody TitersDay 2229 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Seroprotected Participants for HI Antibody TitersDay 10 Participants
Age Group >=65: FLU Q-PAN H5N8 750_BNumber of Seroprotected Participants for HI Antibody Titers6 months post dose 213 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Seroprotected Participants for HI Antibody TitersDay 10 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Seroprotected Participants for HI Antibody TitersDay 2233 Participants
Age Group >=65: FLU Q-PAN H5N8 750_ANumber of Seroprotected Participants for HI Antibody Titers6 months post dose 220 Participants

Source: ClinicalTrials.gov · Data processed: Jun 12, 2026