Safety and Immunogenicity of Three Dosage Levels of Swine... | NCT01855945

Safety and Immunogenicity of Three Dosage Levels of Swine... | NCT01855945 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	3.75 µg H3N2c HA + 0.125 mL MF59	Biological: Swine Influenza
Group B	Experimental	7.5 µg H3N2c HÁ + 0.250 mL MF59	Biological: Swine Influenza
Group C	Experimental	15 µg H3N2c unadjuvanted	Biological: Swine Influenza

Name	Type	Description	Arm Group Labels	Other Names
Swine Influenza	Biological	Comparison of different dosages of vaccines	Group A Group B Group C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.	Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to <9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.	Day 1 through Day 7 after each vaccination
Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.	Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to <18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.	Day 1 through Day 7 after each vaccination
Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.	Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to < 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.	Day 1 through Day 7 after each vaccination
Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.	Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.	Day 1 through Day 7 after each vaccination
Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.	The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported. The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported.

Secondary Outcomes

Measure	Description	Time Frame
Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).	The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females 3 years of age and older
Individuals or, (for children and adolescents) parents or legal guardians, who have given written consent after the nature of the study has been explained according to local regulatory requirements. Assent is required depending on age of child/adolescent
Individuals in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator
Individuals who can comply with study procedures and are available for follow-up

Exclusion Criteria:

Individuals with behavioral or cognitive impairment, including psychiatric illness, as determined by the investigator's clinical judgement may interfere with the subject's ability to participate in study
Individuals with any progressive or severe neurologic disorder, seizure disorder or recent history of Guillian-Barré syndrome
Individuals or (for children and adolescents) parents or legal guardians who are not able to comprehend and to follow all required study procedures for the whole period of the study
Individuals with a history of illness/with an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if he/she participates in the study
Individuals who have a suspected/confirmed diagnosis for any Adverse event of Special interest
Individuals with known or suspected impairment of the immune system including, but not limited to:
- autoimmune disease such as rheumatoid arthritis, HIV infection, hypo- or agammaglobulinemia;
- autoimmune disorders;
- Systemic therapy with corticosteroids or other immunosuppressive therapy.
- Receipt of immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the study
Individuals who are pregnant or breastfeeding. Female subjects of childbearing potential must have a negative pregnancy test prior to study vaccines being administered
If female, "of childbearing potential", sexually active, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry
"Of childbearing potential" is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy
Acceptable birth control methods are defined as one or more of the following:
1. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring);
2. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse;
3. Intrauterine device (IUD);
4. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the subject's study entry.
If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination
Individuals who are allergic to any of the vaccine components.
For children 17 years of age and younger: Individuals who have had ever a malignancy
For adults 18 years or older: Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years
Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study
Individuals with a body temperature >38°C (>100.4°F) or any acute illness within 3 days of intended study vaccination
Individuals who have had a previous confirmed or suspected illness from swine flu (H3N2v)
Individuals who have received any prior H3N2v vaccine
Individuals who have received any other type of influenza vaccination (e.g., "seasonal") within 14 days prior to enrolment, or who plans to receive influenza vaccine during the treatment phase of this study (seasonal influenza vaccination is allowed after Day 43/Visit 3)
Individuals who received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study or who are planning to receive any (non-influenza) vaccine within 4 weeks from the study vaccines
Individuals who are research staff involved with the clinical study or family/household members of research staff
Individuals with a BMI > 35 kg/m2 (adults), > 29 kg/m2 (adolescents), or > 21 kg/m2 (children)
Individuals with a history of drug or alcohol abuse within the past 2 years

Contacts/Locations Module

Name	Affiliation	Role
Novartis Vaccines and Diagnostics	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
51, Northern California Clinical Research Center		Redding	California	96001	United States
47, Benchmark Research

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25538277	Derived	Johnson C, Hohenboken M, Poling T, Jaehnig P, Kanesa-Thasan N. Safety and Immunogenicity of Cell Culture-Derived A/H3N2 Variant Influenza Vaccines: A Phase I Randomized, Observer-Blind, Dose-Ranging Study. J Infect Dis. 2015 Jul 1;212(1):72-80. doi: 10.1093/infdis/jiu826. Epub 2014 Dec 23.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
FG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Adverse Event		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG0040 subjects FG0050 subjects FG0061 subjects FG0070 subjects FG0080 subjects FG0090 subjects FG0100 subjects FG0110 subjects
Death		FG0000 subjects FG0010 subjects FG0020 subjects FG0030 subjects FG004
Lost to Follow-up		FG00011 subjects FG00110 subjects FG0027 subjects FG0033 subjects FG004
Other - Unclassified		FG0001 subjects FG0011 subjects FG0021 subjects FG0030 subjects FG004
Withdrawal by Subject		FG0004 subjects FG0010 subjects FG0024 subjects FG0031 subjects FG004

Arm/Group Information

ID	Title	Description
BG000	A/H3N2C + 1/2 MF59 : 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
BG001	A/H3N2C + MF59 : 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
BG002	A/H3N2C : 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
BG003	A/H3N2C + 1/2 MF59 : 9 TO <18 YEARS	Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
BG004	A/H3N2C + MF59 : 9 TO <18 YEARS	Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
BG005	A/H3N2C : 9 TO <18 YEARS	Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
BG006	A/H3N2C + 1/2 MF59 : 18 TO <65 YEARS	Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
BG007	A/H3N2C + MF59 : 18 TO <65 YEARS	Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
BG008	A/H3N2C : 18 TO <65 YEARS	Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
BG009	A/H3N2C + 1/2 MF59 : ≥65 YEARS	Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
BG010	A/H3N2C + MF59 : ≥65 YEARS	Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
BG011	A/H3N2C : ≥65 YEARS	Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
BG012	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

YEARS

Title

Denominators

Categories

Title	Measurements
	BG0006± 1.7 BG0016± 1.6 BG0026.2± 1.6 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00030 BG00127 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects (3 to <9 Years of Age) Reporting Solicited Adverse Events (AEs) Following Vaccination With H3N2 Monovalent Vaccine.

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (3 to <9 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Analysis was done on Solicited Safety Set.

Posted

Number

Number of Subjects

Day 1 through Day 7 after each vaccination

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS	Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS	Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
OG002	A/H3N2C - Age Group: 3 TO <9 YEARS	Subjects, 3 to < 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.

Units	Counts
Participants	OG00049 OG00153 OG00249

Title

Denominators

Categories

ANY- Vac. 1

Title	Measurements
	OG00031 OG00136 OG00218

ANY- Vac. 2 (N= 45,52,48)

Primary

Number of Subjects (9 to <18 Years of Age) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (9 to <18 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Analysis was done on Solicited Safety Set.

Posted

Number

Number of Subjects

Day 1 through Day 7 after each vaccination

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 - Age Group: 9 TO <18 YEARS	Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59 Subjects 3 to <9 years.
OG001	A/H3N2C + MF59 - Age Group: 9 TO <18 YEARS	Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C - Age Group: 9 TO <18 YEARS	Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.

Primary

Number of Subjects (18 to < 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (18 to < 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Analysis was done on Solicited Safety Set.

Posted

Number

Number of Subjects

Day 1 through Day 7 after each vaccination

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 - Age Group: 18 TO <65 YEARS	Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 - Age Group: 18 TO <65 YEARS	Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C - Age Group: 18 TO <65 YEARS	Subjects 18 to <65 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.

Primary

Number of Subjects (≥ 65 Years) Reporting Solicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.

Safety and tolerability of H3N2 monovalent vaccine was assessed in terms of the number of subjects (≥ 65 years of age) reporting solicited local and systemic adverse events and other adverse events after each vaccination.

Analysis was done on Solicited Safety Set.

Posted

Number

Number of Subjects

Day 1 through Day 7 after each vaccination

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 - Age Group: ≥65 YEARS	Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 - Age Group: ≥65 YEARS	Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
OG002	A/H3N2C - Age Group: ≥65 YEARS	Subjects ≥65 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 15 µg H3N2c antigen.

Primary

Number of Subjects (3 to ≥ 65 Years of Age) Reporting Unsolicited Adverse Events Following Vaccination With H3N2 Monovalent Vaccine.

The number of subjects reporting any unsolicited adverse events (AEs) from day 1 through day 21 after last vaccination within each vaccine group are reported.

The number of subjects reporting any serious adverse events (SAEs), AEs leading to withdrawal from the study, medically attended AEs, AE of special interest (AESI), new onset chronic disease (NOCDs) from day 1 through day 366, after receiving with H3N2 monovalent vaccine are reported.

Analysis was done on unsolicited safety dataset i.e. all subjects in the exposed population who have post-vaccination unsolicited adverse event records.

Posted

Number

Number of subjects

Day 1 through Day 366

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C Age Group: 3 TO <9 YEARS

Primary

Percentages of Subjects (3 to ≥ 65 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition (HI) Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.

The percentages of subjects (3 to ≥ 65 years of age) achieving seroconversion or significant increase in HI antibody titers against H3N2 homologous strain, three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.

Seroconversion is defined as HI titer ≥1:40 for subjects negative at baseline (HI titer <1:10); or a minimum 4-fold increase in HI titer for subjects positive at baseline (HI titer ≥1:10) on Day 22 and Day 43.

Analysis was done on Full Analysis Set.

Posted

Number

95% Confidence Interval

Percentages of Subjects

Day 22, Day 43 post vaccination

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C Age Group: 3 TO <9 YEARS

Secondary

Geometric Mean HI Antibody Titers (GMTs) Following Vaccination With H3N2 Monovalent Vaccine (3 to ≥ 65 Years of Age).

The HI antibody titers against H3N2 homologous strain at baseline (Day 1), three weeks after first (Day 22) and second (Day 43) vaccination and persisting titers at six months (Day 183) and one year (Day 366) after vaccination are reported in terms of GMTs is reported across subjects with age groups 3 to ≥ 65 years.

Analysis was done on Full Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Titers

Day 1, Day 22, Day 43, Day 183 and Day 366 post vaccination

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.

Secondary

Geometric Mean Ratio of Subjects (3 to ≥ 65 Years of Age) Post Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.

The geometric mean ratio (GMR) of post versus pre-vaccination HI antibody titers against H3N2 homologous strain following vaccination as compared to baseline titers are reported for after first (Day 22/Day 1) and second (Day 43/Day 1) vaccination and for persisting titers at six months (Day 183/Day1) and one year (Day 366/Day 1) is reported across subjects with age groups 3 to ≥ 65 years.

Analysis was done on Full Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Ratios

Day 22/Day 1, Day 43/Day 1, Day 183/Day 1, Day 366/Day 1

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.

Secondary

Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.

The percentages of subjects (3 to ≥ 65 years of age) demonstrating HI titers ≥1:40 against H3N2 homologous strain on Day 183 and Day 366 post vaccination.

Analysis was done on the full analysis set.

Posted

Number

95% Confidence Interval

Percentages of Subjects

Day 183 and Day 366 post vaccination

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
OG003

Secondary

Percentages of Subjects (3 to ≥ 61 Years of Age) With Seroconversion or Significant Increase in Hemagglutination Inhibition Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.

The percentage of subjects achieving seroconversion or significant increase for HI antibody titers at three weeks after receiving first (Day 22) and second (Day 43) vaccination is reported, across age groups of 3 to ≥61 years.

Analysis was done on Full Analysis Set.

Posted

Number

95% Confidence Interval

Percentages of Subjects

Day 22, Day 43 post vaccination

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C Age Group: 3 TO <9 YEARS

Secondary

Percentages of Subjects (3 to ≥ 61 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.

The percentages of subjects achieving HI titers ≥1:40 against H3N2 homologous strain at three weeks after receiving first (day 22) and second (day 43) vaccination, is reported across age groups of 3 to ≥ 61 years.

Analysis was done on Full Analysis Set.

Posted

Number

95% Confidence Interval

Percentages of Subjects

Day 1, Day 22, Day 43 post vaccination

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.

Primary

Percentages of Subjects (3 to ≥ 65 Years of Age) Achieving HI Titers ≥1:40 Following Vaccination With H3N2 Monovalent Vaccine.

The percentages of subjects (3 to ≥ 65 years of age) achieving HI titers ≥1:40 against H3N2 homologous strain at baseline (Day 1) and three weeks after receiving first (Day 22) and second (Day 43) vaccination are reported.

Analysis was done on Full Analysis Set.

Posted

Number

95% Confidence Interval

Percentages of Subjects

Day 1, Day 22, Day 43 post vaccination

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.

Secondary

GMR in Subjects (3 to ≥ 61 Years of Age) of Post-vaccination Versus Pre-vaccination HI Antibody Titers Following Vaccination With H3N2 Monovalent Vaccine.

GMR of post-vaccination versus pre-vaccination HI GMTs following vaccination with H3N2 monovalent vaccine is reported across subjects with age groups 3 to ≥ 61 years.

Analysis was done on Full Analysis Set.

Posted

Geometric Mean

95% Confidence Interval

Ratios

Day 22/Day 1, Day 43/Day 1, Day183/ Day 1, Day 366/Day 1

ID	Title	Description
OG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
OG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
OG002	A/H3N2C Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	0	50	36	50
EG001	A/H3N2C + MF59 Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	1	54	46	54
EG002	A/H3N2C Age Group: 3 TO <9 YEARS	Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	0	50	30	50
EG003	A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS	Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	0	54	44	54
EG004	A/H3N2C + MF59 Age Group: 9 TO <18 YEARS	Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	0	51	42	51
EG005	A/H3N2C Age Group: 9 TO <18 YEARS	Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	1	53	45	53
EG006	A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS	Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	3	51	35	51
EG007	A/H3N2C + MF59 Age Group: 18 TO <65 YEARS	Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	0	54	43	54
EG008	A/H3N2C Age Group: 18 TO <65 YEARS	Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	1	48	30	48
EG009	A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS	Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.	2	52	33	52
EG010	A/H3N2C + MF59 Age Group: >=65 YEARS	Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.	5	49	31	49
EG011	A/H3N2C Age Group: >=65 YEARS	Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.	5	51	32	51

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG0030 affected54 at risk EG0040 affected51 at risk EG0050 affected53 at risk EG0061 affected51 at risk EG0070 affected54 at risk EG0080 affected48 at risk EG0090 affected52 at risk EG0100 affected49 at risk EG0110 affected51 at risk
CORONARY ARTERY THROMBOSIS	Cardiac disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
SURGICAL FAILURE	General disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
APPENDICITIS	Infections and infestations	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
PNEUMONIA	Infections and infestations	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0011 affected54 at risk EG0020 affected50 at risk EG003
SEPSIS	Infections and infestations	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
HEAD INJURY	Injury, poisoning and procedural complications	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
HUMERUS FRACTURE	Injury, poisoning and procedural complications	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
OVERDOSE	Injury, poisoning and procedural complications	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
HEPATIC ENZYME INCREASED	Investigations	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
PANCREATIC CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
DEPRESSION	Psychiatric disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0011 affected54 at risk EG0020 affected50 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
AORTIC RUPTURE	Vascular disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
ARTERIOSCLEROSIS	Vascular disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
DIARRHOEA	Gastrointestinal disorders	17.1	Non-systematic Assessment	EG0001 affected50 at risk EG0015 affected54 at risk EG0021 affected50 at risk EG0035 affected54 at risk EG0045 affected51 at risk EG0056 affected53 at risk EG0068 affected51 at risk EG00715 affected54 at risk EG0084 affected48 at risk EG0097 affected52 at risk EG0104 affected49 at risk EG0115 affected51 at risk
NAUSEA	Gastrointestinal disorders	17.1	Non-systematic Assessment	EG0006 affected50 at risk EG0015 affected54 at risk EG0021 affected50 at risk EG003
VOMITING	Gastrointestinal disorders	17.1	Non-systematic Assessment	EG0004 affected50 at risk EG0014 affected54 at risk EG0023 affected50 at risk EG003
FATIGUE	General disorders	17.1	Non-systematic Assessment	EG0007 affected50 at risk EG00111 affected54 at risk EG0027 affected50 at risk EG003
INJECTION SITE BRUISING	General disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0012 affected54 at risk EG0023 affected50 at risk EG003
INJECTION SITE ERYTHEMA	General disorders	17.1	Non-systematic Assessment	EG0004 affected50 at risk EG0015 affected54 at risk EG0021 affected50 at risk EG003
INJECTION SITE HAEMORRHAGE	General disorders	17.1	Non-systematic Assessment	EG0003 affected50 at risk EG0012 affected54 at risk EG0020 affected50 at risk EG003
INJECTION SITE INDURATION	General disorders	17.1	Non-systematic Assessment	EG0004 affected50 at risk EG0017 affected54 at risk EG0020 affected50 at risk EG003
INJECTION SITE PAIN	General disorders	17.1	Non-systematic Assessment	EG00031 affected50 at risk EG00138 affected54 at risk EG00223 affected50 at risk EG003
MALAISE	General disorders	17.1	Non-systematic Assessment	EG0009 affected50 at risk EG00111 affected54 at risk EG0023 affected50 at risk EG003
PYREXIA	General disorders	17.1	Non-systematic Assessment	EG0003 affected50 at risk EG0015 affected54 at risk EG0020 affected50 at risk EG003
NASOPHARYNGITIS	Infections and infestations	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0012 affected54 at risk EG0024 affected50 at risk EG003
PHARYNGITIS	Infections and infestations	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0012 affected54 at risk EG0020 affected50 at risk EG003
PHARYNGITIS STREPTOCOCCAL	Infections and infestations	17.1	Non-systematic Assessment	EG0001 affected50 at risk EG0015 affected54 at risk EG0022 affected50 at risk EG003
SINUSITIS	Infections and infestations	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0011 affected54 at risk EG0022 affected50 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0011 affected54 at risk EG0022 affected50 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	17.1	Non-systematic Assessment	EG0006 affected50 at risk EG0013 affected54 at risk EG0022 affected50 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	17.1	Non-systematic Assessment	EG0002 affected50 at risk EG0011 affected54 at risk EG0021 affected50 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	17.1	Non-systematic Assessment	EG0006 affected50 at risk EG0013 affected54 at risk EG0022 affected50 at risk EG003
HEADACHE	Nervous system disorders	17.1	Non-systematic Assessment	EG0008 affected50 at risk EG0017 affected54 at risk EG0024 affected50 at risk EG003
SOMNOLENCE	Nervous system disorders	17.1	Non-systematic Assessment	EG0003 affected50 at risk EG0014 affected54 at risk EG0022 affected50 at risk EG003
EATING DISORDER	Psychiatric disorders	17.1	Non-systematic Assessment	EG0001 affected50 at risk EG0013 affected54 at risk EG0021 affected50 at risk EG003
IRRITABILITY	Psychiatric disorders	17.1	Non-systematic Assessment	EG0003 affected50 at risk EG0014 affected54 at risk EG0024 affected50 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0023 affected50 at risk EG003
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0011 affected54 at risk EG0020 affected50 at risk EG003
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0021 affected50 at risk EG003
RASH	Skin and subcutaneous tissue disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0021 affected50 at risk EG003
HYPERTENSION	Vascular disorders	17.1	Non-systematic Assessment	EG0000 affected50 at risk EG0010 affected54 at risk EG0020 affected50 at risk EG003

Title

Denominators

Categories

ANY- Vac. 1

Title	Measurements
	OG00037 OG00140 OG00235

ANY- Vac. 2 (N=52,48,53)

Title	Measurements
	OG00030 OG00124 OG00227

INJECTION SITE REACTIONS- Vacc. 1

Title	Measurements
	OG00035 OG00134 OG00227

INJECTION SITE REACTIONS- Vacc. 2

Title	Measurements
	OG00024 OG00120 OG00223

ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=53,51,53)

Title	Measurements
	OG0000 OG0011 OG0020

ECCHYMOSIS (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52)

Title	Measurements
	OG0000 OG0011 OG0020

ERYTHEMA (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53)

Title	Measurements
	OG0000 OG0013 OG0021

ERYTHEMA (mm), ≥ 6y (T.II) (2nd Vac.,N=51,48,52)

Title	Measurements
	OG0001 OG0012 OG0021

INDURATION (mm), ≥ 6y (T.II) (1st Vac.,N=52,51,53)

Title	Measurements
	OG0002 OG0017 OG0022

INDURATION (mm), ≥ 6y (T.II) (2nd Vac.,N=52,48,52)

Title	Measurements
	OG0003 OG0014 OG0021

SYSTEMIC REACTIONS- Vacc. 1

Title	Measurements
	OG00025 OG00132 OG00226

SYSTEMIC REACTIONS- Vacc. 2

Title	Measurements
	OG00017 OG00114 OG00215

ARTHRALGIA (1st Vac.,N=51,50,51)

Title	Measurements
	OG0003 OG0013 OG0027

ARTHRALGIA (2nd Vac.,N=49,48,52)

Title	Measurements
	OG0004 OG0011 OG0022

BODY TEMPERATURE >=38C (1st Vac.,N=53,51,53)

Title	Measurements
	OG0000 OG0011 OG0021

BODY TEMPERATURE ≥38°C (2nd Vac.,N=51,48,52)

Title	Measurements
	OG0000 OG0011 OG0020

DIARRHEA (1st Vac.,N=51,51,51)

Title	Measurements
	OG0003 OG0015 OG0022

DIARRHEA (2nd Vac.,N=50,47,49)

Title	Measurements
	OG0002 OG0012 OG0024

FATIGUE (1st Vac.,N=53,51,53)

Title	Measurements
	OG00012 OG00116 OG00218

FATIGUE (2nd Vac.,N=51,48,53)

Title	Measurements
	OG0009 OG00112 OG0029

HEADACHE (1st Vac.,N=53,50,53)

Title	Measurements
	OG00013 OG00116 OG00211

HEADACHE (2nd Vac.,N=50,48,53)

Title	Measurements
	OG00011 OG0019 OG0029

LOSS OF APPETITE (1st Vac.,N=53,51,51)

Title	Measurements
	OG0006 OG0019 OG0026

LOSS OF APPETITE (2nd Vac.,N=51,48,49)

Title	Measurements
	OG0005 OG0014 OG0022

MALAISE (1st Vac.,N=53,51,51)

Title	Measurements
	OG00010 OG00112 OG00210

MALAISE (2nd Vac.,N=51,48,49)

Title	Measurements
	OG0007 OG0015 OG0024

MYALGIA (1st Vac.,N=52,51,53)

Title	Measurements
	OG0006 OG0019 OG0025

MYALGIA (2nd Vac.,N=50,48,53)

Title	Measurements
	OG0005 OG0012 OG0022

NAUSEA (1st Vac.,N=53,51,53)

Title	Measurements
	OG0009 OG00110 OG0025

NAUSEA (2nd Vac.,N=50,48,53)

Title	Measurements
	OG0003 OG0013 OG0026

PREV.OF PAIN/FEVER (1st Vac.,N=54,49,52)

Title	Measurements
	OG0000 OG0013 OG0020

PREV.OF PAIN/FEVER (2nd Vac.,N=50,47,53)

Title	Measurements
	OG0000 OG0011 OG0021

TREAT.OF PAIN/FEVER (1st Vac.,N=54,50,52)

Title	Measurements
	OG0005 OG0014 OG0022

TREAT.OF PAIN/FEVER (2nd Vac.,N=49,47,53)

Title	Measurements
	OG0003 OG0012 OG0021

VOMITING (1st Vac.,N=53,51,51)

Title	Measurements
	OG0002 OG0011 OG0020

VOMITING (2nd Vac.,N=50,48,49)

Title	Measurements
	OG0001 OG0010 OG0020

Title

Denominators

Categories

ANY- Vac. 1

Title	Measurements
	OG00030 OG00140 OG00227

ANY- Vac. 2 (N=47,51,48)

Title	Measurements
	OG00021 OG00128 OG00221

INJECTION SITE REACTIONS- Vacc. 1

Title	Measurements
	OG00023 OG00132 OG00219

INJECTION SITE REACTIONS- Vacc. 2

Title	Measurements
	OG00017 OG00124 OG00215

ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=50,52,45)

Title	Measurements
	OG0000 OG0011 OG0020

ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48)

Title	Measurements
	OG0000 OG0010 OG0021

ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,47)

Title	Measurements
	OG0000 OG0015 OG0020

ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=46,50,48)

Title	Measurements
	OG0000 OG0011 OG0020

INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=50,53,46)

Title	Measurements
	OG0001 OG0018 OG0021

INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=46,51,48)

Title	Measurements
	OG0001 OG0012 OG0020

SYSTEMIC REACTIONS- Vacc. 1

Title	Measurements
	OG00023 OG00127 OG00219

SYSTEMIC REACTIONS- Vacc. 2

Title	Measurements
	OG00015 OG00120 OG00213

ARTHRALGIA (1st Vac.,N=50,51,45)

Title	Measurements
	OG0004 OG0015 OG0023

ARTHRALGIA (2nd Vac.,N=46,48,48)

Title	Measurements
	OG0003 OG0014 OG0025

BODY TEMPERATURE ≥38°C (1st Vac.,N=51,54,47)

Title	Measurements
	OG0002 OG0011 OG0020

BODY TEMPERATURE ≥38°C (2nd Vac.,N=47,50,47)

Title	Measurements
	OG0000 OG0010 OG0020

DIARRHEA (1st Vac.,N=49,52,46)

Title	Measurements
	OG0006 OG00110 OG0023

DIARRHEA (2nd Vac.,N=44,50,47)

Title	Measurements
	OG0004 OG0016 OG0021

FATIGUE (1st Vac.,N=50,53,47)

Title	Measurements
	OG00010 OG00111 OG0028

FATIGUE (2nd Vac.,N=45,48,48)

Title	Measurements
	OG0007 OG0018 OG0027

HEADACHE (1st Vac.,N=51,53,47)

Title	Measurements
	OG00011 OG00111 OG00210

HEADACHE (2nd Vac.,N=47,49,48)

Title	Measurements
	OG0009 OG0019 OG0028

LOSS OF APPETITE (1st Vac.,N=50,53,47)

Title	Measurements
	OG0004 OG0014 OG0024

LOSS OF APPETITE (2nd Vac.,N=46,50,47)

Title	Measurements
	OG0000 OG0014 OG0021

MALAISE (1st Vac.,N=49,53,47)

Title	Measurements
	OG00012 OG00112 OG0024

MALAISE (2nd Vac.,N=45,50,47)

Title	Measurements
	OG0003 OG00110 OG0024

MYALGIA (1st Vac.,N=51,51,45)

Title	Measurements
	OG0007 OG0017 OG0026

MYALGIA (2nd Vac.,N=47,48,48)

Title	Measurements
	OG0002 OG0015 OG0024

NAUSEA (1st Vac.,N=50,52,47)

Title	Measurements
	OG0003 OG0015 OG0023

NAUSEA (2nd Vac.,N=47,50,47)

Title	Measurements
	OG0003 OG0015 OG0022

PREV.OF PAIN/FEVER (1st Vac.,N=49,52,48)

Title	Measurements
	OG0000 OG0010 OG0020

PREV.OF PAIN/FEVER (2nd Vac.,N=46,50,46)

Title	Measurements
	OG0000 OG0011 OG0020

TREAT.OF PAIN/FEVER (1st Vac.,N=49,53,48)

Title	Measurements
	OG0005 OG0014 OG0021

TREAT.OF PAIN /FEVER (2nd Vac.,N=46,50,46)

Title	Measurements
	OG0001 OG0012 OG0020

VOMITING (1st Vac.,N=49,53,47)

Title	Measurements
	OG0000 OG0010 OG0022

VOMITING (2nd Vac.,N=46,50,47)

Title	Measurements
	OG0000 OG0011 OG0021

Title

Denominators

Categories

ANY- Vac. 1

Title	Measurements
	OG00023 OG00129 OG00215

ANY- Vac. 2 (N=51,45,48)

Title	Measurements
	OG00014 OG00117 OG00214

INJECTION SITE REACTIONS- Vac. 1

Title	Measurements
	OG00011 OG00121 OG0026

INJECTION SITE REACTIONS- Vac. 2

Title	Measurements
	OG0009 OG00114 OG0025

ECCHYMOSIS (mm), ≥ 6y (T.II, 1st Vac.,N=51,49,50)

Title	Measurements
	OG0002 OG0010 OG0020

ECCHYMOSIS (mm), ≥ 6y (T.II, 2nd Vac.,N=49,45,48)

Title	Measurements
	OG0000 OG0010 OG0021

ERYTHEMA (mm), ≥ 6y (T.II, 1st Vac.,N=51,45,49)

Title	Measurements
	OG0001 OG0011 OG0022

ERYTHEMA (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48)

Title	Measurements
	OG0001 OG0012 OG0021

INDURATION (mm), ≥ 6y (T.II, 1st Vac.,N=51,48,50)

Title	Measurements
	OG0001 OG0012 OG0022

INDURATION (mm), ≥ 6y (T.II, 2nd Vac.,N=49,44,48)

Title	Measurements
	OG0000 OG0012 OG0021

SYSTEMIC REACTIONS- Vacc. 1

Title	Measurements
	OG00017 OG00116 OG00213

SYSTEMIC REACTIONS- Vacc. 2

Title	Measurements
	OG0008 OG00111 OG00211

ARTHRALGIA (1st Vac.,N=47,45,50)

Title	Measurements
	OG0003 OG0014 OG0023

ARTHRALGIA (2nd Vac.,N=50,43,47)

Title	Measurements
	OG0003 OG0011 OG0022

BODY TEMPERATURE ≥38°C (1st Vac.,N=51,48,50)

Title	Measurements
	OG0000 OG0010 OG0020

BODY TEMPERATURE ≥38°C (2nd Vac.,N=51,44,48)

Title	Measurements
	OG0000 OG0010 OG0021

DIARRHEA (1st Vac.,N=50,47,48)

Title	Measurements
	OG0005 OG0013 OG0024

DIARRHEA (2nd Vac.,N=49,44,44)

Title	Measurements
	OG0002 OG0011 OG0021

FATIGUE (1st Vac.,N=49,48,49)

Title	Measurements
	OG0008 OG0018 OG0024

FATIGUE (2nd Vac.,N=51,44,48)

Title	Measurements
	OG0005 OG0016 OG0023

HEADACHE (1st Vac.,N=50,49,50)

Title	Measurements
	OG0008 OG0016 OG0024

HEADACHE (2nd Vac.,N=51,44,48)

Title	Measurements
	OG0005 OG0012 OG0023

LOSS OF APPETITE (1st Vac.,N=50,48,49)

Title	Measurements
	OG0006 OG0012 OG0022

LOSS OF APPETITE (2nd Vac.,N=50,45,46)

Title	Measurements
	OG0003 OG0011 OG0021

MALAISE (1st Vac.,N=50,48,49)

Title	Measurements
	OG0005 OG0016 OG0022

MALAISE (2nd Vac.,N=50,45,46)

Title	Measurements
	OG0004 OG0013 OG0021

MYALGIA (1st Vac.,N=49,48,50)

Title	Measurements
	OG0004 OG0015 OG0023

MYALGIA (2nd Vac.,N=50,43,48)

Title	Measurements
	OG0002 OG0011 OG0023

NAUSEA (1st Vac.,N=51,49,50)

Title	Measurements
	OG0005 OG0013 OG0023

NAUSEA (2nd Vac.,N=50,45,47)

Title	Measurements
	OG0002 OG0012 OG0021

PREV.OF PAIN/FEVER (1st Vac.,N=48,46,50)

Title	Measurements
	OG0001 OG0010 OG0020

PREV.OF PAIN/FEVER (2nd Vac.,N=50,44,48)

Title	Measurements
	OG0000 OG0010 OG0020

TREAT.OF PAIN/FEVER (1st Vac.,N=48,46,50)

Title	Measurements
	OG0000 OG0013 OG0021

TREAT.OF PAIN/FEVER (2nd Vac.,N=50,44,48)

Title	Measurements
	OG0000 OG0011 OG0023

VOMITING (1st Vac.,N=51,48,49)

Title	Measurements
	OG0000 OG0010 OG0021

VOMITING (2nd Vac.,N=49,45,46)

Title	Measurements
	OG0000 OG0010 OG0020

Title

Denominators

Categories

Any AE (Day 1 to Day 366)

Title	Measurements
	OG0000 OG0011 OG0020 OG0030 OG0040 OG0051 OG0063 OG0070 OG0081 OG0092 OG0105 OG0115

At least possibly related AE

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Any SAE

Title	Measurements
	OG0000 OG0011 OG0020 OG003

At least possibly related

Title	Measurements
	OG0000 OG0010 OG0020 OG003

AE leading to withdrawal

Title	Measurements
	OG0000 OG0011 OG0020 OG003

Medically attended AEs

Title	Measurements
	OG0008 OG00121 OG00214 OG003

AESI

Title	Measurements
	OG0000 OG0010 OG0020 OG003

NOCD

Title	Measurements
	OG0000 OG0010 OG0021 OG003

Death

Title	Measurements
	OG0000 OG0010 OG0020 OG003

Title

Denominators

Categories

Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51)

Title	Measurements
	OG00096(85.5 to 99.5) OG00198(90.1 to 99.95) OG00271(56.7 to 83.4) OG00388(76.6 to 95.6) OG00498(88.9 to 99.95) OG00585(72.4 to 93.3) OG00673(59 to 84.4) OG00789(77.4 to 95.8) OG00867(51.6 to 79.6) OG00957(42.2 to 71.2) OG01071(56.7 to 83.4) OG01161(46.1 to 74.2)

Day 43(N=43,53,48,52,49,53,51,52,48,48,49,50)

Title	Measurements
	OG000100(91.8 to 100) OG001100(93.3 to 100) OG00292(80 to 97.7) OG003

Title

Denominators

Categories

Day 1

Title	Measurements
	OG0008.48(6.89 to 10) OG0018.26(6.74 to 10) OG0028.8(7.10 to 11) OG00328(21 to 37) OG00429(22 to 39) OG00527(20 to 35) OG00634(26 to 44) OG00752(40 to 68) OG00842(32 to 56) OG00936(28 to 47) OG01032(25 to 42) OG01126(20 to 34)

Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51)

Title	Measurements
	OG000192(134 to 275) OG001277(198 to 387) OG00293(65 to 132) OG003

Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50)

Title	Measurements
	OG000524(396 to 694) OG001679(527 to 874) OG002198(152 to 258) OG003

Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49)

Title	Measurements
	OG00097(75 to 126) OG001145(113 to 185) OG00267(52 to 86) OG003

Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49)

Title	Measurements
	OG00046(35 to 61) OG00170(53 to 91) OG00237(28 to 49) OG003

Title

Denominators

Categories

Day22/Day1

Title	Measurements
	OG00022(15 to 32) OG00133(23 to 47) OG00211(7.51 to 16) OG00314(9.58 to 19) OG00415(10 to 22) OG00513(8.91 to 18) OG0067.54(5.41 to 11) OG00711(8.16 to 16) OG0085.35(3.80 to 7.55) OG0093.79(2.71 to 5.29) OG0106.64(4.75 to 9.28) OG0115.13(3.70 to 7.13)

Day43/Day1 (N=43,53,48,52,49,53,51,52,48,48,49,50)

Title	Measurements
	OG00059(43 to 81) OG00182(62 to 109) OG00223(17 to 31) OG003

Day183/Day1(N=39,44,42,47,50,47,45,50,46,47,48,49)

Title	Measurements
	OG00010(7.48 to 14) OG00117(13 to 23) OG0027.17(5.31 to 9.68) OG003

Day366/Day1(N=38,43,38,47,50,47,43,47,46,48,46,49)

Title	Measurements
	OG0004.83(3.43 to 6.79) OG0018.23(5.98 to 11) OG0024.13(2.93 to 5.82) OG003

Title

Denominators

Categories

Day 183 (N=39,44,42,47,50,47,45,50,46,47,48,49)

Title	Measurements
	OG00095(82.7 to 99.4) OG00198(88 to 99.94) OG00281(65.9 to 91.4) OG00398(88.7 to 99.95) OG004100(92.9 to 100) OG005100(92.5 to 100) OG00687(73.2 to 94.9) OG007100(92.9 to 100) OG00887(73.7 to 95.1) OG00991(79.6 to 97.6) OG01094(82.8 to 98.7) OG01188(75.2 to 95.4)

Day 366 (N=38,43,38,47,50,47,43,47,46,48,46,49)

Title	Measurements
	OG00082(65.7 to 92.3) OG00191(77.9 to 97.4) OG00258(40.8 to 73.7) OG003

Title

Denominators

Categories

Day 22

Title	Measurements
	OG00096(85.2 to 99.5) OG00198(90.1 to 99.95) OG00271(56.7 to 83.4) OG00389(77 to 95.7) OG00498(88.9 to 99.95) OG00585(72.4 to 93.3) OG00674(59.7 to 86.1) OG00790(77.3 to 96.5) OG00864(47.2 to 78.8) OG00957(43.2 to 70.8) OG01073(59 to 83.9) OG01163(49.9 to 75.4)

Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59)

Title	Measurements
	OG000100(91.8 to 100) OG001100(93.3 to 100) OG00292(80 to 97.7) OG003

Title

Denominators

Categories

Day 1

Title	Measurements
	OG0008(2.1 to 18.5) OG0017(2 to 17.6) OG00214(5.8 to 26.7) OG00344(30.9 to 58.6) OG00459(44.2 to 72.4) OG00549(35.1 to 63.2) OG00660(45.3 to 74.2) OG00767(52.5 to 80.1) OG00874(57.9 to 87) OG00953(38.8 to 66.3) OG01054(39.7 to 67) OG01144(31.5 to 57.6)

Day 22(N=46,54,49,53,48,53,47,48,39,54,55,60)

Title	Measurements
	OG00096(85.2 to 99.5) OG00198(90.1 to 99.95) OG00278(63.4 to 88.2) OG003

Day 43(N=43,53,48,52,49,53,46,46,39,53,55,59)

Title	Measurements
	OG000100(91.8 to 100) OG001100(93.3 to 100) OG00296(85.7 to 99.5) OG003

Title

Denominators

Categories

Day 1

Title	Measurements
	OG0008(2.1 to 18.2) OG0017(2 to 17.6) OG00214(5.8 to 26.7) OG00345(31.6 to 59.6) OG00459(44.2 to 72.4) OG00549(35.1 to 63.2) OG00657(42.3 to 70.2) OG00767(53.3 to 79.3) OG00867(51.6 to 79.6) OG00956(41.3 to 70) OG01052(37.4 to 66.3) OG01146(32.2 to 60.5)

Day 22 (N=47,54,49,52,48,53,52,54,48,49,49,51)

Title	Measurements
	OG00096(85.5 to 99.5) OG00198(90.1 to 99.95) OG00278(63.4 to 88.2) OG003

Day 43 (N=43,53,48,52,49,53,51,52,48,48,49,50)

Title	Measurements
	OG000100(91.8 to 100) OG001100(93.3 to 100) OG00296(85.7 to 99.5) OG003

Title

Denominators

Categories

Day22/Day1(N=46,54,49,53,48,53,47,48,39,54,55,60)

Title	Measurements
	OG00022(15 to 32) OG00133(23 to 47) OG00211(7.50 to 16) OG00314(9.76 to 19) OG00415(10 to 22) OG00513(8.91 to 18) OG0067.8(5.48 to 11) OG00712(8.62 to 17) OG0084.93(3.35 to 7.25) OG0094.05(2.93 to 5.59) OG0106.73(4.88 to 9.28) OG0115.53(4.07 to 7.52)

Day43/Day1(N=43,53,48,52,49,53,46,46,39,53,55,59)

Title	Measurements
	OG00059(43 to 81) OG00182(62 to 109) OG00223(17 to 31) OG003

Day183/ Day1,N=38,44,42,48,50,47,40,44,37,52,54,58

Title	Measurements
	OG0009.96(7.25 to 14) OG00117(13 to 23) OG0027.18(5.32 to 9.70) OG003

Day 366/Day1,N=37,43,38,48,50,47,38,41,37,53,52,58

Title	Measurements
	OG0004.55(3.22 to 6.42) OG0018.26(6.02 to 11) OG0024.09(2.91 to 5.75) OG003

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