Immunogenicity & Safety of GSK's Avian Flu Vaccine 155748... | NCT00719043

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A/Indonesia primed-A/turkey Influenza (H5N1)-F1-Placebo Group	Experimental	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Biological: A/turkey H5N1 vaccine Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) Biological: Placebo
A/Indonesia primed-A/turkey Influenza (H5N1)-F2-Placebo Group	Experimental	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Biological: A/turkey H5N1 vaccine Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) Biological: Placebo
A/Indonesia primed-A/turkey Influenza (H5N1)-F3-Placebo Group	Experimental	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A/turkey H5N1 vaccine	Biological	Administered as an intramuscular (IM) injection	A/Indonesia primed-A/turkey Influenza (H5N1)-F1-Placebo Group A/Indonesia primed-A/turkey Influenza (H5N1)-F2-Placebo Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.	At Day 559
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group	At Day 192
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.	At Days 549 and 559
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.	HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

Secondary Outcomes

Measure	Description	Time Frame
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A male or female 18 years of age or older at the time of the first vaccination.
Written informed consent obtained from the subject.
Stable health status as defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment.
Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.
Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits.
Subjects who the investigator believes can and will comply with the requirements of the protocol

Exclusion Criteria:

Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
Diagnosed with cancer, or treatment for cancer, within 3 years.
- Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible.
- Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll within 3 years of diagnosis, but other histologic types of skin cancer require a 3 year untreated and disease-free window as above.
- Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll.
Presence of an oral temperature ≥ 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
Receipt of systemic glucocorticoids (prednisone >= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment.
Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
Administration of any vaccines within 30 days before the first study vaccine dose.
Previous administration of any H5N1 vaccine.
Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 18 months following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial.
Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
Known pregnancy or a positive urine beta-human chorionic gonadotropin (β-hCG) test result prior to vaccination.
Lactating or nursing.
Women of child bearing potential who lack a history of reliable contraceptive practices. The provision of this history does NOT replace the requirement to perform, and obtain negative results in pregnancy urine tests prior to treatments.
Known receipt of analgesic or antipyretic medication with the specific intent of prophylaxis of vaccine reactogenicity on the day of first or any treatment. Subjects on stable chronic regimens of potentially analgesic or anti-pyretic medications for pre-existing diagnoses are not required to discontinue them (to do so would represent evaluation of combined vaccine reactogenicity AND treatment withdrawal - which is not the intent of the protocol).

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Denver	Colorado	80239	United States
GSK Investigational Site

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
110624	Clinical Study Report	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
BG001	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
BG002	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
BG003	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
BG004	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
BG005	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
BG006	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
BG007	Total	Total of all reporting groups

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 Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Posted

Number

Subjects

At Day 559

ID	Title	Description
OG000	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG002	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG003	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Units	Counts
Participants	OG00083 OG00187 OG00280 OG003

Title

Denominators

Categories

Title	Measurements
	OG00071 OG00181 OG00273 OG003

Primary

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group

Posted

Number

Subjects

At Day 192

ID	Title	Description
OG000	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.

Primary

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Days 549 and 559

ID	Title	Description
OG000	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group

Primary

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Days 182 and 192

ID	Title	Description
OG000	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.

Units	Counts
Participants

Primary

Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Posted

Number

Subjects

At Days 549 and 559

ID	Title	Description
OG000	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group

Primary

Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

Posted

Number

Subjects

At Days 182 and 192

ID	Title	Description
OG000	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.

Units	Counts
Participants

Primary

Number of Subjects With Solicited Local Symptoms

Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Posted

Number

Subjects

Within the 7-day (Days 0-6) post vaccination periods

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Primary

Number of Subjects With Solicited General Symptoms

Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Posted

Number

Subjects

Within the 7-day (Days 0-6) post vaccination periods

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Primary

Number of Subjects With Medically-attended Adverse Events (MAEs)

MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Posted

Number

Subjects

From Day 0 to Day 909

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Primary

Number of Subjects With Unsolicited Adverse Events (AEs)

An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Posted

Number

Subjects

Within the 43-day (Days 0-42) post-vaccination periods

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group

Primary

Number of Subjects With Serious Adverse Events (SAEs)

A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.

The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Posted

Number

Subjects

From Day 0 to Day 909

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Secondary

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

Posted

Number

Subjects

At Day 192

ID	Title	Description
OG000	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.

Secondary

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain.

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Days 182 and 192

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Secondary

Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

Posted

Number

Subjects

At Days 182 and 192

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Secondary

Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Posted

Number

Subjects

At Day 224

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Secondary

Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

Posted

Number

Subjects

At Day 591

ID	Title	Description
OG000	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group

Secondary

Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain

GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Posted

Geometric Mean

95% Confidence Interval

Fold increase

At Days 192 and 224

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group

Secondary

Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain

GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Posted

Geometric Mean

95% Confidence Interval

Fold increase

At Day 559

ID	Title	Description
OG000	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001

Secondary

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

Posted

Number

Subjects

At Day 591

ID	Title	Description
OG000	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Secondary

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Posted

Number

Subjects

At Day 224

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001

Secondary

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Days 0, 182,192, 224, 549 and 729

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group

Secondary

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Days 0, 182, 549, 559, 591 and 729

ID	Title	Description
OG000	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group

Secondary

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain.

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Days 0, 182, 192, 224, 549, 559, 591 and 729

ID	Title	Description
OG000	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.

Units	Counts

Secondary

Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain.

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

Posted

Number

Subjects

At Days 0, 182,192, 224, 549 and 729

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group

Secondary

Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Posted

Number

Subjects

At Days 0, 182, 549, 559, 591 and 729

ID	Title	Description
OG000	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group

Secondary

Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain

Posted

Number

Subjects

At Days 0, 182, 192, 224, 549, 559, 591 and 729

ID	Title	Description
OG000	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.

Units	Counts

Secondary

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.

HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Days 0, 10, 42, 182 and 549

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Secondary

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain.

HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Days 0, 10, 42, 182, 549 and 559

ID	Title	Description
OG000	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group

Secondary

Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.

Posted

Number

Subjects

At Day 0, Day 10, Day 42, Day 182 and Day 549

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.
OG001	Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group

Secondary

Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain.

A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Posted

Number

Subjects

At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559

ID	Title	Description
OG000	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Secondary

Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.

This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Posted

Number

Subjects

At Days 10 and 42

ID	Title	Description
OG000	Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Pumarix™ and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.

Secondary

Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. This outcome measure only concerns the Naïve Placebo-A/turkey H5N1-Formulation 3 Group, for whom the pre-vaccination time point corresponds to the Day 192 time point.

Posted

Number

Subjects

At Days 192 and 224

ID	Title	Description
OG000	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.

Units

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	12	120	106	120
EG001	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	14	121	109	121
EG002	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	11	119	106	119
EG003	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	9	119	103	119
EG004	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	11	122	106	122
EG005	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group	Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	15	120	101	120
EG006	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.	12	120	106	120

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0011 affected121 at risk EG0021 affected119 at risk EG0030 affected119 at risk EG004
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0011 affected121 at risk EG0021 affected119 at risk EG003
Appendicitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0002 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Bradycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Chest discomfort	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Endometriosis	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Syncope	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Abortion spontaneous incomplete	Pregnancy, puerperium and perinatal conditions	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Amnesia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Anaphylactic shock	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Cellulitis gangrenous	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Delirium	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Drug abuse	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Endocarditis noninfective	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Iron deficiency anaemia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Mass	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Meningitis viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Mitral valve disease	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Pain	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Pancreatic mass	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Post procedural infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Presyncope	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Septic shock	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0011 affected121 at risk EG0020 affected119 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0021 affected119 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003
Uterine infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected120 at risk EG0010 affected121 at risk EG0020 affected119 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain	General disorders	MedDRA	Systematic Assessment	EG00098 affected120 at risk EG001100 affected121 at risk EG002101 affected119 at risk EG00393 affected119 at risk EG004102 affected122 at risk EG00590 affected120 at risk EG00695 affected120 at risk
Redness	General disorders	MedDRA	Systematic Assessment	EG0008 affected120 at risk EG0014 affected121 at risk EG00212 affected119 at risk EG003
Swelling	General disorders	MedDRA	Systematic Assessment	EG0006 affected120 at risk EG0017 affected121 at risk EG00215 affected119 at risk EG003
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00045 affected120 at risk EG00150 affected121 at risk EG00247 affected119 at risk EG003
Headache	General disorders	MedDRA	Systematic Assessment	EG00044 affected120 at risk EG00150 affected121 at risk EG00247 affected119 at risk EG003
Joint pain	General disorders	MedDRA	Systematic Assessment	EG00033 affected120 at risk EG00137 affected121 at risk EG00236 affected119 at risk EG003
Muscle aches	General disorders	MedDRA	Systematic Assessment	EG00054 affected120 at risk EG00152 affected121 at risk EG00259 affected119 at risk EG003
Shivering	General disorders	MedDRA	Systematic Assessment	EG00012 affected120 at risk EG00118 affected121 at risk EG00216 affected119 at risk EG003
Sweating	General disorders	MedDRA	Systematic Assessment	EG00015 affected120 at risk EG00120 affected121 at risk EG00215 affected119 at risk EG003
Fever	General disorders	MedDRA	Systematic Assessment	EG0002 affected120 at risk EG0015 affected121 at risk EG0026 affected119 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00015 affected120 at risk EG0019 affected121 at risk EG0029 affected119 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0009 affected120 at risk EG0018 affected121 at risk EG0029 affected119 at risk EG003
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0008 affected120 at risk EG00111 affected121 at risk EG0024 affected119 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0009 affected120 at risk EG0017 affected121 at risk EG0026 affected119 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected120 at risk EG0012 affected121 at risk EG00210 affected119 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0004 affected120 at risk EG0014 affected121 at risk EG0024 affected119 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0007 affected120 at risk EG0015 affected121 at risk EG0026 affected119 at risk EG003

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