Dose-finding Study of Four Dosage Levels of an H7N9 Influ... | NCT01928472

Dose-finding Study of Four Dosage Levels of an H7N9 Influ... | NCT01928472 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	H7N9c low dose with adjuvant	Biological: H7N9c low dose with adjuvant
Group B	Experimental	H7N9c medium dose with adjuvant	Biological: H7N9c medium dose with adjuvant
Group C	Experimental	H7N9c high dose with adjuvant	Biological: H7N9c high dose with adjuvant
Group D	Experimental	H7N9c high dose without adjuvant	Biological: H7N9c high dose without adjuvant

Name	Type	Description	Arm Group Labels	Other Names
H7N9c low dose with adjuvant	Biological		Group A
H7N9c medium dose with adjuvant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)	Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination	Day 1 and 43
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)	Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.	Day 43
Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)	Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination. Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.	Day 43
Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)	Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.	Day 1 and 43
Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine	Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.

Secondary Outcomes

Measure	Description	Time Frame
Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)	Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.	Day 1 and 22
Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)

Contacts/Locations Module

Name	Affiliation	Role
Novartis Vaccines and Diagnostics	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Site 04: Accelovance		San Diego	California	92108	United States
Site 01: Accelovance

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
FG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Death		FG0000 subjects FG0010 subjects FG0021 subjects FG0030 subjects
Withdrawal by Subject		FG0004 subjects FG0014 subjects FG0021 subjects FG0032 subjects
Lost to Follow-up		FG0002 subjects FG0013 subjects FG0024 subjects FG0030 subjects
Administrative Reason		FG0002 subjects FG0011 subjects FG0020 subjects FG0030 subjects
Unclassified		FG0000 subjects FG0010 subjects FG0021 subjects FG0030 subjects

Arm/Group Information

ID	Title	Description
BG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
BG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
BG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
BG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
BG004	TOTAL	Total of all reporting groups

Units	Counts
Participants	BG00098 BG001104 BG00298 BG003102 BG004402

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

year

Title

Denominators

Categories

Title	Measurements
	BG00038.3± 13.1 BG00140.3± 12.5 BG00242.6± 13.1 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
FEMALE	BG00060 BG00157 BG002

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

Geometric Mean Titers Of Subjects After Each Vaccination Of a Cell-Culture Derived H7N9c Monovalent Vaccine, Hemagglutination Inhibition Assay (Day 43)

Immunogenicity was measured by Hemagglutination Inhibition (HI) assay and summarized through the geometric mean titers (GMTs) at baseline (day 1) and three weeks after the second (day 43) vaccination

The analysis was done on Full Analysis Set - Subjects who received at least one study vaccination and provided immunogenicity at day 43 (FAS-Day 43).

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1 and 43

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.

Units	Counts
Participants	OG00098 OG001103 OG00298 OG003

Title	Denominators	Categories
Day 1	ParticipantsOG00098 ParticipantsOG001103 ParticipantsOG00298 ParticipantsOG003

Primary

Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 43)

Geometric mean ratio (GMR) of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after second (day 43) vaccination.

FAS-Day 43

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 43

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.

Primary

Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)

Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after second (day 43) vaccination.

Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.

FAS-Day 43

Posted

Number

95% Confidence Interval

Percentages of subjects

Day 43

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj

Primary

Percentages Of Subjects With an HI Titers ≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 43)

Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after second (Day 43) vaccination.

FAS-Day 43.

Posted

Number

95% Confidence Interval

Percentages of subejcts

Day 1 and 43

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.

Secondary

Geometric Mean Titers Of Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Monovalent Vaccine, HI Assay (Day 22)

Immunogenicity was measured by HI assay and summarized through the GMTs at baseline (day 1) and three weeks after the first (day 22) vaccination.

FAS-Day 22

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1 and 22

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.

Secondary

Geometric Mean Ratios In Subjects After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Day 22)

GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs three weeks after first (day 22) vaccination.

FAS-Day 22

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 22

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.

Secondary

Percentages Of Subjects Achieving Seroconversion After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)

Percentage of subjects achieving HI seroconversion in HI titer was measured three weeks after first (day 22) vaccination.

Seroconversion is defined as postvaccination HI titer> 40 for subjects with baseline (day 1); HI titer <1:10 or a minimum 4-fold increase in titer for subjects with baseline titer >1:10.

FAS-Day 22

Posted

Number

95% Confidence Interval

Percentages of subjects

Day 22

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj

Secondary

Percentages Of Subjects With an HI Titers≥1:40 After Each Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Day 22)

Percentage of subjects who achieved HI titers≥1:40 was measured at baseline (day 1) and three weeks after first (Day 22) vaccination.

FAS-Day 22

Posted

Number

95% Confidence Interval

Percentages of subjects

Day 1 and 22.

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.

Secondary

Geometric Mean Titers at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)

The immunogenicity was measured as GMTs in subjects as persistence at six months (day 183) and one year (day 366) after the first vaccination as measured by Hemagglutination Inhibition (HI) Assay.

FAS-Day 183 and FAS-Day 366

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 183 and 366.

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.

Secondary

Geometric Mean Ratios at Six Months and One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine, HI Assay (Persistence)

GMR of subjects was calculated as the ratio of postvaccination to prevaccination HI GMTs six months (day 183) and one year (day 366) after the first vaccination.

FAS-Day 183 and FAS-Day 366

Posted

Geometric Mean

95% Confidence Interval

Ratio

Day 183 and 366

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.

Secondary

Percentages Of Subjects Achieving Seroconversion at Six Months and One Year After Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)

Percentage of subjects with HI seroconversion was measured as HI titer persistence at six months (day 183) and one year (day 366) after the first vaccination.

Seroconversion is defined as postvaccination HI titer>40 for subjects with baseline (day 1); HI titer <1:10 or a minimum four-fold increase in titer for subjects with baseline titer>1:10.

FAS-Day 183 and FAS-Day 366

Posted

Number

95% Confidence Interval

Percentages of subjects

Day 183 and 366

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj

Secondary

Percentages Of Subjects With an HI Titers ≥1:40 at Six Months and at One Year After the First Vaccination Of A Cell-Culture Derived H7N9c Vaccine (Persistence)

Percentages of subjects who achieved HI titers≥1:40 was measured at six months (day 183) and one year (day 366) after the first vaccination of a cell-culture derived H7N9 vaccine.

FAS-Day 183 and FAS-Day 366

Posted

Number

95% Confidence Interval

Percentages of subjects

Day 183 and 366

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.

Primary

Number of Subjects Reporting Unsolicited Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine

Safety was assessed as the number of subjects who reported any AEs, and at least possibly related AEs are collected from day 1 to day 43 following vaccination with adjuvanted and unadjuvanted formulations of H7N9c vaccine.

Analysis was done on unsolicited safety set - All subjects in the exposed set with unsolicited AE data.

Posted

Number

participants

Day 1 to Day 43

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj

Primary

Number of Subjects Reporting Unsolicited Serious Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine

The number of subjects reporting unsolicited adverse events after receiving adjuvanted and unadjuvanted formulations of H7N9c vaccine was reported. Safety was assessed as the number of subjects who reported SAEs, at least possibly related SAEs, new onset of chronic diseases (NOCDs), medically attended AEs, AEs of Special Interest (AESIs), AEs leading to withdrawal from the study were collected from day 1 to day 366 following vaccination with adjuvanted and unadjuvanted formulations of H7N9 vaccine.

Analysis was done on unsolicited safety set.

Posted

Number

participants

Day 1 to Day 366.

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.

Primary

Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Adjuvanted and Unadjuvanted Formulations of H7N9c Vaccine

Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 to day 7 of vaccination of adjuvanted and unadjuvanted formulations of H7N9c vaccine.

Analysis was done on the solicited safety set - All subjects in the exposed set with solicited AE data.

Posted

Number

participants

Day 1 through Day 7 after each vaccination.

ID	Title	Description
OG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
OG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
OG003	High Dose + No Adj

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Low Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.	2	98	71	98
EG001	Medium Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.	2	103	87	103
EG002	High Dose + Adj	Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.	3	98	79	98
EG003	High Dose + No Adj	Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.	1	102	62	102
EG004	TOTAL	Total of all reporting groups.	8	401	299	401

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected103 at risk EG0020 affected98 at risk EG0030 affected102 at risk EG0041 affected401 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected103 at risk EG0020 affected98 at risk EG003
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected103 at risk EG0020 affected98 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0010 affected103 at risk EG0021 affected98 at risk EG003
APPENDICITIS	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected103 at risk EG0020 affected98 at risk EG003
INFECTION	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected103 at risk EG0020 affected98 at risk EG003
OSTEOMYELITIS	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0010 affected103 at risk EG0020 affected98 at risk EG003
MULTIPLE FRACTURES	Injury, poisoning and procedural complications	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0010 affected103 at risk EG0021 affected98 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected103 at risk EG0020 affected98 at risk EG003
CEREBRAL INFARCTION	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected103 at risk EG0020 affected98 at risk EG003
HEADACHE	Nervous system disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected103 at risk EG0020 affected98 at risk EG003
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected103 at risk EG0020 affected98 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0001 affected98 at risk EG0010 affected103 at risk EG0020 affected98 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0010 affected103 at risk EG0021 affected98 at risk EG003
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA (17.1)	Non-systematic Assessment	EG0000 affected98 at risk EG0011 affected103 at risk EG0020 affected98 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DIARRHOEA	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG00014 affected98 at risk EG00114 affected103 at risk EG0029 affected98 at risk EG00312 affected102 at risk EG00449 affected401 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG00018 affected98 at risk EG00119 affected103 at risk EG00213 affected98 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA (17.1)	Systematic Assessment	EG0005 affected98 at risk EG0014 affected103 at risk EG0023 affected98 at risk EG003
FATIGUE	General disorders	MedDRA (17.1)	Systematic Assessment	EG00026 affected98 at risk EG00136 affected103 at risk EG00232 affected98 at risk EG003
INJECTION SITE INDURATION	General disorders	MedDRA (17.1)	Systematic Assessment	EG0001 affected98 at risk EG0016 affected103 at risk EG0022 affected98 at risk EG003
INJECTION SITE PAIN	General disorders	MedDRA (17.1)	Systematic Assessment	EG00055 affected98 at risk EG00180 affected103 at risk EG00267 affected98 at risk EG003
MALAISE	General disorders	MedDRA (17.1)	Systematic Assessment	EG00015 affected98 at risk EG00132 affected103 at risk EG00229 affected98 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0005 affected98 at risk EG0012 affected103 at risk EG0023 affected98 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (17.1)	Non-systematic Assessment	EG0004 affected98 at risk EG0018 affected103 at risk EG0025 affected98 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (17.1)	Systematic Assessment	EG0007 affected98 at risk EG00117 affected103 at risk EG00214 affected98 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Systematic Assessment	EG00011 affected98 at risk EG00128 affected103 at risk EG00221 affected98 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (17.1)	Systematic Assessment	EG00017 affected98 at risk EG00133 affected103 at risk EG00224 affected98 at risk EG003
HEADACHE	Nervous system disorders	MedDRA (17.1)	Systematic Assessment	EG00034 affected98 at risk EG00145 affected103 at risk EG00231 affected98 at risk EG003

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases
D001715	Bird Diseases
D000820	Animal Diseases

Title

Denominators

Categories

Day 1

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Title	Measurements
	OG0000(0 to 4) OG0010(0 to 4) OG0020(0 to 4) OG003

Day 43

- ParticipantsOG00094
- ParticipantsOG001103
- ParticipantsOG00297
- ParticipantsOG003102

Title

Denominators

Categories

Day 1

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Title	Measurements
	OG0005(4.95 to 5.05) OG0015(4.95 to 5.05) OG0025(4.95 to 5.05) OG003

Day 22 (N=96,103,97,102)

- ParticipantsOG00096
- ParticipantsOG001103
- ParticipantsOG00297
- ParticipantsOG003102

Title

Denominators

Categories

Day 183

- ParticipantsOG00090
- ParticipantsOG001101
- ParticipantsOG00294
- ParticipantsOG003101

Title	Measurements
	OG0005.17(4.84 to 5.52) OG0015.43(5.1 to 5.78) OG0025.99(5.61 to 6.39) OG003

Day 366 (N=90,96,91,100)

- ParticipantsOG00090
- ParticipantsOG00196
- ParticipantsOG00291
- ParticipantsOG003100

Title

Denominators

Categories

Day 183/Day 1

- ParticipantsOG00090
- ParticipantsOG001101
- ParticipantsOG00294
- ParticipantsOG003101

Title	Measurements
	OG0001.03(0.97 to 1.1) OG0011.09(1.02 to 1.15) OG0021.2(1.13 to 1.27) OG003

Day 366/Day 1

- ParticipantsOG00090
- ParticipantsOG00196
- ParticipantsOG00291
- ParticipantsOG003100

Title

Denominators

Categories

Day 183

- ParticipantsOG00090
- ParticipantsOG001101
- ParticipantsOG00294
- ParticipantsOG003101

Title	Measurements
	OG0000(0 to 4) OG0011(0.025 to 5) OG0021(0.027 to 6) OG003

Day 366

- ParticipantsOG00090
- ParticipantsOG00196
- ParticipantsOG00291
- ParticipantsOG003100

Title

Denominators

Categories

Day 183

- ParticipantsOG00090
- ParticipantsOG001101
- ParticipantsOG00294
- ParticipantsOG003101

Title	Measurements
	OG0000(0 to 4) OG0011(0.025 to 5) OG0021(0.027 to 6) OG003

Day 366

- ParticipantsOG00090
- ParticipantsOG00196
- ParticipantsOG00291
- ParticipantsOG003100

Title

Denominators

Categories

SAEs

Title	Measurements
	OG0002 OG0012 OG0023 OG0031

At least possibly related SAEs

Title	Measurements
	OG0000 OG0010 OG0020 OG003

AEs leading to withdrawal

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Medically attended AE

Title	Measurements
	OG00033 OG00143 OG00234 OG003

AESI

Title	Measurements
	OG0000 OG0010 OG0020 OG003

NOCD

Title	Measurements
	OG0001 OG0017 OG0025 OG003

Death

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Title

Denominators

Categories

Any local-Vaccination I

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Title	Measurements
	OG00047 OG00177 OG00260 OG003

Vaccination I, Pain

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Ecchymosis

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Erythema

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Induration

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Any systemic-Vaccination I

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Nausea

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Myalgia

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Arthralgia

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Headache

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Fatigue

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Vomiting

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Diarrhea

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Loss of appetite

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Malaise

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I,Body Temp (≥38°C)

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003102

Vaccination I, Prevention of pain and/or fever

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003

Vaccination I, Treatment of pain and/or fever

- ParticipantsOG00098
- ParticipantsOG001103
- ParticipantsOG00298
- ParticipantsOG003

Any Local-Vaccination II

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Pain

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Ecchymosis

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Erythema

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Induration

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Any Systemic-Vaccination II (N=95,102,97,102)

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003

Vaccination II, Nausea

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Myalgia

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Arthralgia

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Headache

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Fatigue

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Vomiting

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Diarrhea

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Loss of appetite

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Malaise

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Body Temp (≥38°C)

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003102

Vaccination II, Prevention of pain and/or fever

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003

Vaccination II, Treatment of pain and (or)fever

- ParticipantsOG00095
- ParticipantsOG001102
- ParticipantsOG00297
- ParticipantsOG003

ID	Term
D007251	Influenza, Human
D005585	Influenza in Birds

ID	Term
D010592	Pharmaceutic Aids
D004364	Pharmaceutical Preparations
D020313	Specialty Uses of Chemicals
D020164	Chemical Actions and Uses