Phase 3 Pivotal Trial of NanoFlu™ in Older Adults | NCT04120194

Label	Type	Description	Intervention Names
NanoFlu	Experimental	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.	Biological: NanoFlu
Fluzone Quadrivalent	Active Comparator	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0.	Biological: Fluzone Quadrivalent

Name	Type	Description	Arm Group Labels	Other Names
NanoFlu	Biological	Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.	NanoFlu

Measure	Description	Time Frame
HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR)	Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) expressed as GMFR on Day 28	Day 28
Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants	Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) summarized in terms of SCR on Day 28	Day 0 - Day 28
Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)	Number of subjects with solicited local and systemic AEs over 7 days post-injection (ie, Day 0 through Day 6, inclusive).	Day 0 - Day 6
Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs)	Number of subjects with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) - including AESIs - through 1-year post-injection.	Day 0 - Day 364
Number of Subjects With MAAEs, SAEs, SNMCs	Number of subjects with MAEs, SAEs, and SNMCs - including AESIs.	Day 0 - Day 27

Measure	Description	Time Frame
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)	Homologous influenza strains and 1 antigenically drifted strain expressed as GMT	Day 0 - Day 28
HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)

Name	Affiliation	Role
Clinical Development	Novavax, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
US135		Hollywood	Florida	33024	United States
US045

PubMed Identifier	Type	Citation	Retractions
34563277	Derived	Shinde V, Cho I, Plested JS, Agrawal S, Fiske J, Cai R, Zhou H, Pham X, Zhu M, Cloney-Clark S, Wang N, Zhou B, Lewis M, Price-Abbott P, Patel N, Massare MJ, Smith G, Keech C, Fries L, Glenn GM. Comparison of the safety and immunogenicity of a novel Matrix-M-adjuvanted nanoparticle influenza vaccine with a quadrivalent seasonal influenza vaccine in older adults: a phase 3 randomised controlled trial. Lancet Infect Dis. 2022 Jan;22(1):73-84. doi: 10.1016/S1473-3099(21)00192-4. Epub 2021 Sep 23.

ID	Title	Description
FG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
FG001	Fluzone Quadrivalent

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 31, 2019	Oct 10, 2022

ID	Title	Description
BG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
BG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0001333 BG0011319 BG0022652

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as Ratio of Geometric Mean Fold Ratio (GMFR)

Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) expressed as GMFR on Day 28

Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol.

Posted

Geometric Mean

95% Confidence Interval

Geometric Mean Fold Ratio

Day 28

ID	Title	Description
OG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
OG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Units	Counts
Participants	OG0001280 OG0011286

Title

Denominators

Categories

A/Brisbane/02/2018 (H1N1)

Title	Measurements
	OG0001.9(1.8 to 2.0) OG0011.7(1. to 1.8)

A/Kansas/14/2017 (H3N2)

Title	Measurements
	OG000

Primary

Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses for Vaccine Homologous Influenza Strains Expressed as a Percentage of Participants

Egg-Based HAI Assay responses for all 4 vaccine homologous influenza strains (ie, 2 influenza A and 2 influenza B strains) summarized in terms of SCR on Day 28

Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol.

Posted

Number

95% Confidence Interval

percentage of participants

Day 0 - Day 28

ID	Title	Description
OG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
OG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Units	Counts
Participants

Primary

Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)

Number of subjects with solicited local and systemic AEs over 7 days post-injection (ie, Day 0 through Day 6, inclusive).

Safety Population, including all study subjects who provided consent, were randomized, and received a test article. The Safety Population was analyzed as actually treated (ie, based on the actual dose received).

Posted

Number

participants

Day 0 - Day 6

ID	Title	Description
OG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
OG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Units	Counts
Participants

Primary

Number of Subjects With Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs)

Number of subjects with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Significant New Medical Conditions (SNMCs) - including AESIs - through 1-year post-injection.

Posted

Number

participants

Day 0 - Day 364

ID	Title	Description
OG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
OG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Units	Counts
Participants

Primary

Number of Subjects With MAAEs, SAEs, SNMCs

Number of subjects with MAEs, SAEs, and SNMCs - including AESIs.

Safety Population, including all study subjects who provided consent, were randomized and received a test article. The Safety Population was analyzed as actually treated (ie, based on the actual dose received).

Posted

Number

participants

Day 0 - Day 27

ID	Title	Description
OG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
OG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Units	Counts
Participants	OG000

Secondary

HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Titers (GMT)

Homologous influenza strains and 1 antigenically drifted strain expressed as GMT

Per-Protocol (PP) Population including all subjects provided consent, were randomized and received the assigned dose of the test article according to protocol, had HAI serology results for Day 0 and Day 28, and had no major protocol deviations affecting the primary immunogenicity outcomes as determined by the sponsor prior to database lock and unblinding.

Posted

Geometric Mean

95% Confidence Interval

titers

Day 0 - Day 28

ID	Title	Description
OG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
OG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Units	Counts

Secondary

HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as Geometric Mean Fold Ratio (GMFR)

Wild-Type HAI Assay Homologous influenza strains and 1 antigenically drifted strain expressed as GMFR.

Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol.

Posted

Geometric Mean

95% Confidence Interval

Geometric Mean Fold Rise

Day 28 - 364

ID	Title	Description
OG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
OG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Units	Counts
Participants

Secondary

Subjects Who Seroconverted as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain

Wild-Type HAI Assay Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroconversion Rate (SCR).

Per-Protocol (PP) Population including all subjects who provided consent, were randomized and received the assigned dose of the test article according to protocol.

Posted

Number

95% Confidence Interval

percentage of participants

Day 28 - Day 364

ID	Title	Description
OG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
OG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Units	Counts
Participants

Secondary

Subjects Who Seroprotected as Determined by HAI Titers to All Vaccine Homologous Influenza Strains and at Least 1 Antigenically Drifted Strain Expressed as SPR

Homologous Influenza Strains and at least 1 Antigenically Drifted Strain Expressed as Seroprotection Rate (SPR).

Posted

Number

95% Confidence Interval

percentage of participants

Day 28

ID	Title	Description
OG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
OG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.

Units

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0012 events2 affected1,319 at risk
Blood loss anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Acute coronary syndrome	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0012 events2 affected1,319 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0012 events2 affected1,319 at risk
Angina unstable	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0013 events3 affected1,319 at risk
Cardiac failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG0004 events4 affected1,333 at risk EG0014 events4 affected1,319 at risk
Coronary artery disease	Cardiac disorders	Systematic Assessment	EG0003 events3 affected1,333 at risk EG0012 events2 affected1,319 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0012 events2 affected1,319 at risk
Sinus node dysfunction	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Goitre	Endocrine disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0012 events2 affected1,319 at risk
Colonic fistula	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Diverticulum	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Duodenitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Enterocutaneous fistula	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Enterovesical fistula	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Gastric ulcer	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Gastritis erosive	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Gastrointestinal fistula	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0014 events4 affected1,319 at risk
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Hiatus hernia	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0010 events0 affected1,319 at risk
Intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Rectal prolapse	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Small intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Asthenia	General disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Complication associated with device	General disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Death	General disorders	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0010 events0 affected1,319 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Bile duct stone	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Hepatic cirrhosis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Ischaemic hepatitis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Appendicitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0013 events3 affected1,319 at risk
Arthritis infective	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
COVID-19	Infections and infestations	Systematic Assessment	EG0004 events4 affected1,333 at risk EG0012 events2 affected1,319 at risk
COVID-19 pneumonia	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Cellulitis staphylococcal	Infections and infestations	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0010 events0 affected1,319 at risk
Cholecystitis infective	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Diverticulitis	Infections and infestations	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0011 events1 affected1,319 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Gastroenteritis viral	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Infected skin ulcer	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Localised infection	Infections and infestations	Systematic Assessment	EG0003 events3 affected1,333 at risk EG0010 events0 affected1,319 at risk
Osteomyelitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Pelvic abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0008 events8 affected1,333 at risk EG0016 events6 affected1,319 at risk
Pneumonia bacterial	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Postoperative abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Renal abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Respiratory syncytial virus bronchiolitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0004 events4 affected1,333 at risk EG0012 events2 affected1,319 at risk
Septic shock	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0012 events1 affected1,319 at risk
Staphylococcal bacteraemia	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Streptococcal bacteraemia	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Urosepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Wound infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Accidental overdose	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Ankle fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0010 events0 affected1,319 at risk
Cartilage injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Face injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Femur fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0010 events0 affected1,319 at risk
Hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Incisional hernia	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Lower limb fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0010 events0 affected1,319 at risk
Multiple fractures	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Rib fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Road traffic accident	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Skin laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0010 events0 affected1,319 at risk
Spinal fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0012 events2 affected1,319 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Tendon rupture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Tibia fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Wrist fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Fluid overload	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0010 events0 affected1,319 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0015 events5 affected1,319 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Endometrial cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Follicular thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Hormone receptor positive breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Renal cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Ataxia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Carotid artery disease	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Carotid artery stenosis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Cerebral infarction	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Cerebrovascular accident	Nervous system disorders	Systematic Assessment	EG0003 events3 affected1,333 at risk EG0010 events0 affected1,319 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Haemorrhage intracranial	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Hemiparesis	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Intracranial aneurysm	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Ischaemic stroke	Nervous system disorders	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0011 events1 affected1,319 at risk
Metabolic encephalopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Subarachnoid haemorrhage	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0012 events2 affected1,319 at risk
Transient aphasia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Transient global amnesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Hallucination, visual	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Mental status changes	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0003 events3 affected1,333 at risk EG0012 events2 affected1,319 at risk
Anuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Ureterolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Prostatomegaly	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0011 events1 affected1,319 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0012 events2 affected1,319 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0010 events0 affected1,319 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0013 events3 affected1,319 at risk
Respiratory acidosis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events4 affected1,333 at risk EG0012 events2 affected1,319 at risk
Accelerated hypertension	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Aortic aneurysm	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Aortic stenosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Arterial spasm	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0002 events2 affected1,333 at risk EG0011 events1 affected1,319 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Hypertensive urgency	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Shock haemorrhagic	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,333 at risk EG0011 events1 affected1,319 at risk
Thrombosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,333 at risk EG0010 events0 affected1,319 at risk

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NanoFlu	NanoFlu will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. NanoFlu: Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.	8	1,333	136	1,333	0	1,333
EG001	Fluzone Quadrivalent	Fluzone Quadrivalent will be administered as a single dose (0.5 mL) in the arm muscle on Day 0. Fluzone Quadrivalent: Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.	8	1,319	125	1,319	0	1,319