Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vacc... | NCT00972816

Label	Type	Description	Intervention Names
3.75_(50)MF59	Experimental	3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22	Biological: MF59-eH1N1
7.5_(0) MF59	Experimental	7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22	Biological: MF59-eH1N1
7.5_(50) MF59	Experimental	7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22	Biological: MF59-eH1N1
7.5_(100) MF59	Experimental	7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22	Biological: MF59-eH1N1
15_(0) MF59	Experimental	15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22	Biological: MF59-eH1N1
15_(50)MF59	Experimental

Name	Type	Description	Arm Group Labels	Other Names
MF59-eH1N1	Biological	MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).	15_(0) MF59

Measure	Description	Time Frame
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations	HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.	Day 22, Day 29, Day 43, Day 202 and Day 387

Measure	Description	Time Frame
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group	Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group. PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.	Day 22, Day 29, Day 43, Day 202 and Day 387

Name	Affiliation	Role
Novartis Vaccines and Diagnostics	Novartis	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Premier Health Research Center, LLC		Downey	California	90241-4982	United States
Madera Family Medical Group

ID	Title	Description
FG000	3.75_(50) MF59	3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
FG001	7.5_(0) MF59	7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

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

Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations

HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity.

PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively.

PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.

PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.

The analysis was performed on per protocol set (PPS) population

Posted

Number

95% Confidence Interval

percentage of subjects

Day 22, Day 29, Day 43, Day 202 and Day 387

ID	Title	Description
OG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen
OG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1
OG002	7.5_(50)MF59	50% of MF59 with 7.5 µg A/H1N1 antigen
OG003	7.5_(100)MF59	100% of MF59 with 7.5 µg A/H1N1 antigen
OG004	15 Without MF59	1 dose of 15 µg A/H1N1
OG005	15_(50)MF59	50% of MF59 with 15 µg A/H1N1 antigen
OG006	15_(100)MF59	100% of MF59 with 15 µg A/H1N1 antigen
OG007	30 Without MF59	1 dose of 30 µg A/H1N1

Units	Counts
Participants	OG000152 OG001156 OG002156 OG003

Title

Denominators

Categories

HI titer ≥1:40 (Baseline)

Title	Measurements
	OG00011(6 to 17) OG0019(5 to 15) OG00213(8 to 19) OG003

Secondary

Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group

Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group.

PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively.

PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.

The analysis was performed on per protocol set (PPS) population

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 22, Day 29, Day 43, Day 202 and Day 387

ID	Title	Description
OG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen
OG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1
OG002	7.5_(50)MF59	50% of MF59 with 7.5 µg A/H1N1 antigen
OG003	7.5_(100)MF59	100% of MF59 with 7.5 µg A/H1N1 antigen
OG004

Secondary

Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.

HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.

The analysis was done on PPS population

Posted

Number

95% Confidence Interval

percentage of Subjects

Day 22, Day 29, Day 43

ID	Title	Description
OG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen
OG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1
OG002

Secondary

Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010

Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines

Subgroups without recent seasonal flu vaccine:

PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively.

PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively.

Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively.

PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively

The analysis was done on PPS population.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1, Day 22, Day 29, Day 43

ID	Title	Description
OG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen
OG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1
OG002	7.5_(50)MF59	50% of MF59 with 7.5 µg A/H1N1 antigen

Secondary

Antibody Response Based on Baseline Seropositivity

Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.

Subgroups with baseline HI titer < 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively.

Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively.

Posted

Number

95% Confidence Interval

percentage of Subjects

Day 22, Day 29 and Day 43

ID	Title	Description
OG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen
OG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1
OG002	7.5_(50)MF59	50% of MF59 with 7.5 µg A/H1N1 antigen
OG003	7.5_(100)MF59	100% of MF59 with 7.5 µg A/H1N1 antigen
OG004

Secondary

Geometric Mean Titers (GMTs) Based on Baseline Seropositivity

Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline.

Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10).

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1, Day 22, Day 29, Day 43

ID	Title	Description
OG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen
OG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1
OG002	7.5_(50)MF59	50% of MF59 with 7.5 µg A/H1N1 antigen
OG003	7.5_(100)MF59	100% of MF59 with 7.5 µg A/H1N1 antigen
OG004	15 Without MF59

Secondary

Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination

Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).

The analysis was performed on safety set population

Posted

Number

Participants

7 days after first vaccination

ID	Title	Description
OG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen
OG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1
OG002	7.5_(50)MF59	50% of MF59 with 7.5 µg A/H1N1 antigen
OG003	7.5_(100)MF59	100% of MF59 with 7.5 µg A/H1N1 antigen
OG004	15 Without MF59	1 dose of 15 µg A/H1N1

Secondary

Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination

Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)

The analysis was performed on safety set population

Posted

Number

Participant

7 days after second vaccination

ID	Title	Description
OG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen
OG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1
OG002	7.5_(50)MF59	50% of MF59 with 7.5 µg A/H1N1 antigen
OG003	7.5_(100)MF59	100% of MF59 with 7.5 µg A/H1N1 antigen
OG004	15 Without MF59	1 dose of 15 µg A/H1N1

Secondary

Number of Participants Reporting Unsolicited Adverse Events (AEs)

Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)

The analysis was done on unsolicited safety set population.

Posted

Number

Subjects

Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination

ID	Title	Description
OG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen
OG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1
OG002	7.5_(50)MF59	50% of MF59 with 7.5 µg A/H1N1 antigen
OG003	7.5_(100)MF59	100% of MF59 with 7.5 µg A/H1N1 antigen
OG004	15 Without MF59

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Febrile Convulsion	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 events0 affected171 at risk EG0010 events0 affected168 at risk EG0021 events1 affected169 at risk EG0030 events0 affected168 at risk EG0040 events0 affected168 at risk EG0050 events0 affected168 at risk EG0060 events0 affected167 at risk EG0070 events0 affected169 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0021 affected169 at risk EG003
Cerumen Impaction	Ear and labyrinth disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0011 affected168 at risk EG0020 affected169 at risk EG003
Appendicitis Perforated	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0021 affected169 at risk EG003
Chronic Tonsillitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Otitis Media Chronic	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Peritonsillar Abscess	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0021 affected169 at risk EG003
Pharyngitis Streptococcal	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Pharyngotonsillitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0011 affected168 at risk EG0020 affected169 at risk EG003
Pneumonia	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0021 affected169 at risk EG003
Staphylococcal Scalded Skin Syndrome	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Viral Infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Altered state of consciousness	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0011 affected168 at risk EG0020 affected169 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Foreign Body	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Ulna Fracture	Injury, poisoning and procedural complications	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0021 affected169 at risk EG003
Aggression	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Bipolar Disorder	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Intermittent Explosive Disorder	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Oppositional Defiant Disorder	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0011 affected168 at risk EG0020 affected169 at risk EG003
Post-Traumatic Stress Disorder	Psychiatric disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0021 affected169 at risk EG003
Ovarian Mass	Reproductive system and breast disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Pharyngeal Stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0011 affected168 at risk EG0020 affected169 at risk EG003
Swelling Face	Skin and subcutaneous tissue disorders	MedDRA (10.1)	Non-systematic Assessment	EG0000 affected171 at risk EG0010 affected168 at risk EG0020 affected169 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00034 affected171 at risk EG00136 affected168 at risk EG00230 affected169 at risk EG00327 affected168 at risk EG00434 affected168 at risk EG00535 affected168 at risk EG00640 affected167 at risk EG00738 affected169 at risk
Nasopharyngitis	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG00014 affected171 at risk EG0014 affected168 at risk EG00210 affected169 at risk EG003
Pyrexia	General disorders	MedDRA (10.1)	Systematic Assessment	EG00041 affected171 at risk EG00134 affected168 at risk EG00238 affected169 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00010 affected171 at risk EG0019 affected168 at risk EG0027 affected169 at risk EG003
Upper respiratory track infection	Infections and infestations	MedDRA (10.1)	Systematic Assessment	EG00029 affected171 at risk EG00136 affected168 at risk EG00223 affected169 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG00022 affected171 at risk EG00114 affected168 at risk EG00227 affected169 at risk EG003
Injection site pain	General disorders	MedDRA (10.1)	Systematic Assessment	EG00098 affected171 at risk EG00170 affected168 at risk EG00285 affected169 at risk EG003
Headache	Nervous system disorders	MedDRA (10.1)	Non-systematic Assessment	EG00037 affected171 at risk EG00131 affected168 at risk EG00239 affected169 at risk EG003
Injection site erythema	General disorders	MedDRA (10.1)	Systematic Assessment	EG00029 affected171 at risk EG00116 affected168 at risk EG00226 affected169 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG00024 affected171 at risk EG00110 affected168 at risk EG00217 affected169 at risk EG003
Fatigue	General disorders	MedDRA (10.1)	Systematic Assessment	EG00033 affected171 at risk EG00122 affected168 at risk EG00231 affected169 at risk EG003
Injection site induration	General disorders	MedDRA (10.1)	Systematic Assessment	EG00023 affected171 at risk EG0015 affected168 at risk EG00219 affected169 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG00021 affected171 at risk EG00120 affected168 at risk EG00213 affected169 at risk EG003
Diarrhea	Gastrointestinal disorders	MedDRA (10.1)	Systematic Assessment	EG00022 affected171 at risk EG00116 affected168 at risk EG00217 affected169 at risk EG003
Injection site swelling	General disorders	MedDRA (10.1)	Systematic Assessment	EG00017 affected171 at risk EG0018 affected168 at risk EG00214 affected169 at risk EG003
Chills	General disorders	MedDRA (10.1)	Systematic Assessment	EG00017 affected171 at risk EG0018 affected168 at risk EG00213 affected169 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.1)	Systematic Assessment	EG0009 affected171 at risk EG0012 affected168 at risk EG00212 affected169 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0003 affected171 at risk EG0015 affected168 at risk EG0024 affected169 at risk EG003
Bronchitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00013 affected171 at risk EG0018 affected168 at risk EG0025 affected169 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00013 affected171 at risk EG0019 affected168 at risk EG00214 affected169 at risk EG003
Pharyngitis Streptococcal	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00017 affected171 at risk EG00119 affected168 at risk EG00218 affected169 at risk EG003
Sinusitis	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0009 affected171 at risk EG0017 affected168 at risk EG0027 affected169 at risk EG003
Viral Infection	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00013 affected171 at risk EG0015 affected168 at risk EG00211 affected169 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00014 affected171 at risk EG0018 affected168 at risk EG00210 affected169 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00012 affected171 at risk EG0017 affected168 at risk EG0026 affected169 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00013 affected171 at risk EG0019 affected168 at risk EG0025 affected169 at risk EG003
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (10.1)	Non-systematic Assessment	EG00010 affected171 at risk EG0019 affected168 at risk EG0027 affected169 at risk EG003
Otitis Media	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG00017 affected171 at risk EG00114 affected168 at risk EG00228 affected169 at risk EG003
OTITIS MEDIA ACUTE	Infections and infestations	MedDRA (10.1)	Non-systematic Assessment	EG0009 affected171 at risk EG0013 affected168 at risk EG0024 affected169 at risk EG003

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment
OG000 OG001	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	3.998	2-Sided	95	2.659	6.009	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG002	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	1.222	2-Sided	95	0.813	1.838	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.661	2-Sided	95	0.440	0.994	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	2.178	2-Sided	95	1.449	3.276	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	1.017	2-Sided	95	0.676	1.528	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.673	2-Sided	95	0.448	1.012	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	1.742	2-Sided	95	1.156	2.626	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG002	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.306	2-Sided	95	0.204	0.458	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.165	2-Sided	95	0.110	0.248	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.545	2-Sided	95	0.363	0.818	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.254	2-Sided	95	0.170	0.381	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.168	2-Sided	95	0.112	0.252	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.436	2-Sided	95	0.290	0.655	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.541	2-Sided	95	0.361	0.811	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	1.783	2-Sided	95	1.188	2.676	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.832	2-Sided	95	0.555	1.246	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.551	2-Sided	95	0.367	0.826	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	1.426	2-Sided	95	0.950	2.140	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	3.295	2-Sided	95	2.196	4.944	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	1.538	2-Sided	95	1.026	2.303	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	1.018	2-Sided	95	0.679	1.526	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	2.635	2-Sided	95	1.754	3.959	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.467	2-Sided	95	0.311	0.7	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.309	2-Sided	95	0.206	0.463	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other	Geometric mean ratio at day 22	0.8	2-Sided	95	0.532	1.203	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG005 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	0.662	2-Sided	95	0.442	0.992	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG005 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	1.714	2-Sided	95	1.142	2.572	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG006 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 22	2.589	2-Sided	95	1.723	3.889	Yes	Non-Inferiority or Equivalence	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.
OG000 OG001	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	4.975	2-Sided	95	3.757	6.589	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG002	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	1.168	2-Sided	95	0.881	1.547	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.880	2-Sided	95	0.665	1.166	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	3.219	2-Sided	95	2.430	4.264	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	1.070	2-Sided	95	0.808	1.417	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.720	2-Sided	95	0.544	0.954	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	2.509	2-Sided	95	1.891	3.330	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG002	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.235	2-Sided	95	0.178	0.310	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.177	2-Sided	95	0.134	0.234	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.647	2-Sided	95	0.489	0.856	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.215	2-Sided	95	0.163	0.284	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.145		95	0.109	0.191	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.504	2-Sided	95	0.381	0.668	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.754	2-Sided	95	0.570	0.997	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	2.756	2-Sided	95	2.083	3.647	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.916	2-Sided	95	0.694	1.211	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.616	2-Sided	95	0.466	1.815	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	2.149	2-Sided	95	1.624	2.843	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	3.656	2-Sided	95	2.764	4.836	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	1.216	2-Sided	95	0.920	1.606	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.818	2-Sided	95	0.619	1.081	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	2.850	2-Sided	95	2.152	3.773	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.332	2-Sided	95	0.251	0.440	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.224	2-Sided	95	0.169	0.296	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.780	2-Sided	95	0.588	1.003	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG005 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	0.673	2-Sided	95	0.509	0.889	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG005 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	2.345	2-Sided	95	1.772	3.102	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG006 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 43	3.485	2-Sided	95	2.633	4.614	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG001	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	2.624	2-Sided	95	1.817	3.789	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG002	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	1.096	2-Sided	95	0.760	1.580	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.888	2-Sided	95	0.615	1.282	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	2.120	2-Sided	95	1.473	3.052	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.876	2-Sided	95	0.610	1.260	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.898	2-Sided	95	0.622	1.298	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67
OG000 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	1.451	2-Sided	95	1.000	2.105	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG002	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.418	2-Sided	95	0.289	0.603	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.338	2-Sided	95	0.235	0.487	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.808	2-Sided	95	0.561	1.165	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.334	2-Sided	95	0.233	0.479	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.342	2-Sided	95	0.237	0.494	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.553	2-Sided	95	0.382	0.801	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.811	2-Sided	95	0.562	1.169	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	1.935	2-Sided	95	1.347	2.780	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.800	2-Sided	95	0.558	1.147	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.820	2-Sided	95	0.568	1.184	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	1.324	2-Sided	95	0.915	1.917	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	2.388	2-Sided	95	1.658	3.438	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.987	2-Sided	95	0.688	1.416	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	1.012	2-Sided	95	0.701	1.460	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	1.634	2-Sided	95	1.128	2.366	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.413	2-Sided	95	0.288	0.592	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.424	2-Sided	95	0.294	0.610	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	0.684	2-Sided	95	0.473	0.990	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG005 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	1.025	2-Sided	95	0.714	1.473	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG005 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	1.656	2-Sided	95	1.150	2.385	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG006 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 202	1.615	2-Sided	95	1.115	2.339	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG001	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	1.906	2-Sided	95	1.177	3.087	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG002	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.945	2-Sided	95	0.583	1.533	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.763	2-Sided	95	0.468	1.245	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	1.818	2-Sided	95	1.119	2.956	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.917	2-Sided	95	0.568	1.481	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.855	2-Sided	95	0.524	1.396	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	1.203	2-Sided	95	0.745	1.943	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG002	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.496	2-Sided	95	0.310	0.794	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.400	2-Sided	95	0.250	0.641	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.954	2-Sided	95	0.596	1.528	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.481	2-Sided	95	0.306	0.758	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.449	2-Sided	95	0.279	0.722	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.631	2-Sided	95	0.398	1.002	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.807	2-Sided	95	0.500	1.304	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	1.924	2-Sided	95	1.193	3.102	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.970	2-Sided	95	0.611	1.541	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.905	2-Sided	95	0.561	1.460	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	1.273	2-Sided	95	0.798	2.030	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	2.383	2-Sided	95	1.474	3.851	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	1.202	2-Sided	95	0.754	1.915	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	1.120	2-Sided	95	0.689	1.821	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	1.576	2-Sided	95	0.987	2.516	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.504	2-Sided	95	0.316	0.805	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.470	2-Sided	95	0.293	0.754	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.662	2-Sided	95	0.414	1.056	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG005 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	0.932	2-Sided	95	0.583	1.492	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG005 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	1.312	2-Sided	95	0.831	2.071	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG006 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric mean ratio at day 387	1.407	2-Sided	95	0.880	2.249	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG001	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	5.428	2-Sided	95	4	7.365	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG002	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	1.091	2-Sided	95	0.804	1.481	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.759	2-Sided	95	0.559	1.031	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other	Geometric Mean Ratio at day 29	3.499	2-Sided	95	2.577	4.751	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.982	2-Sided	95	0.722	1.334	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other	Geometric Mean Ratio at day 29	0.699	2-Sided	95	0.513	0.95	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG000 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	2.513	2-Sided	95	1.846	3.421	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG002	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.201	2-Sided	95	0.149	0.272	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.14	2-Sided	95	0.103	0.189	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.645	2-Sided	95	0.476	0.873	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other	Geometric Mean Ratio at day 29	0.181	2-Sided	95	0.134	0.245	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.129	2-Sided	95	0.095	0.174	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG001 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other	Geometric Mean Ratio at day 29	0.463	2-Sided	95	0.341	0.628	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67
OG002 OG003	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other	Geometric Mean Ratio at day 29	0.696	2-Sided	95	0.514	0.943	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	3.207	2-Sided	95	2.368	4.343	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.9	2-Sided	95	0.665	1.218	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.64	2-Sided	95	0.472	0.868	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG002 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	2.303	2-Sided	95	1.7	3.121	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG004	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	4.608	2-Sided	95	3.398	6.249	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	1.293	2-Sided	95	0.954	1.753	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.92	2-Sided	95	0.677	1.249	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG003 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other	Geometric Mean Ratio at day 29	3.31	2-Sided	95	2.436	4.496	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG005	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.281	2-Sided	95	0.207	0.38	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.2	2-Sided	95	0.147	0.271	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG004 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.718	2-Sided	95	0.529	0.975	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG005 OG006	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	0.712	2-Sided	95	0.524	0.966	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG005 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other.	Geometric Mean Ratio at day 29	2.56	2-Sided	95	1.886	3.474	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.
OG006 OG007	A difference was assumed to be statistically significant if the 2-sided 95% CI around the ratio of GMTs did not contain 1, in which case one group is either statistically significantly superior or statistically inferior to the other	Geometric Mean Ratio at day 29	3.597	2-Sided	95	2.646	4.89	Yes	Non-Inferiority or Equivalence	For pairwise vaccine group compared, least squares GMT and associated 2-sided 95% CI, median, minimum, and maximum HI titer values were determined. The two-sided 95% CIs was calculated and assessed against a non-inferiority margin of 0.5. Subsequently the same non-inferiority hypothesis was tested using a non-inferiority margin of 0.67.

ID	Term
D007251	Influenza, Human
D009976	Orthomyxoviridae Infections

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

ID	Title	Description
BG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen
BG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1
BG002	7.5_(50)MF59	50% of MF59 with 7.5 µg A/H1N1 antigen
BG003	7.5_(100)MF59	100% of MF59 with 7.5 µg A/H1N1 antigen
BG004	15 Without MF59	1 dose of 15 µg A/H1N1
BG005	15_(50)MF59	50% of MF59 with 15 µg A/H1N1 antigen
BG006	15_(100)MF59	100% of MF59 with 15 µg A/H1N1 antigen
BG007	30 Without MF59	1 dose of 30 µg A/H1N1
BG008	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	3.75_(50)MF59	50% of MF59 with 3.75 µg A/H1N1 antigen	0	171	171	171
EG001	7.5 Without MF59	1 dose of 7.5 µg A/H1N1	5	168	168	168
EG002	7.5_(50)MF59	50% of MF59 with 7.5 µg A/H1N1 antigen	7	169	169	169
EG003	7.5_(100)MF59	100% of MF59 with 7.5 µg A/H1N1 antigen	4	168	168	168
EG004	15 Without MF59	1 dose of 15 µg A/H1N1	3	168	168	168
EG005	15_(50)MF59	50% of MF59 with 15 µg A/H1N1 antigen	4	168	168	168
EG006	15_(100)MF59	100% of MF59 with 15 µg A/H1N1 antigen	1	167	167	167
EG007	30 Without MF59	1 dose of 30 µg A/H1N1	0	169	169	169