Immunogenicity & Safety of GSK's Influenza Vaccine 155748... | NCT00616928

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Influenza A (H5N1) 18-64Y Group	Experimental	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Placebo 18-64Y Group	Placebo Comparator	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Biological: Placebo
Influenza A (H5N1) >64Y Group	Experimental	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Biological: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
Placebo >64Y Group	Placebo Comparator	Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted	Biological	Two intramuscular injections at Days 0 and 21.	Influenza A (H5N1) 18-60Y Group Influenza A (H5N1) 18-64Y Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)	A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.	At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)	A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.	At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With Any Solicited Local Symptoms.	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.	During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Number of Subjects With Any Solicited General Symptoms.	Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.	During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration
Number of Subjects With Any Unsolicited Adverse Events (AEs).	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10		At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)
Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10		At Month 6 (Day 182) post Dose 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A male or female 18 years of age or greater at the time of the first vaccination.
Written informed consent obtained from the subject.
Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study.
Among subjects > 49 years of age, stable health status within 1 month prior to enrollment.
Access to a consistent means of telephone contact.
Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.

Exclusion Criteria:

Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports.
Diagnosed with cancer, or treatment for cancer, within 3 years.
An oral temperature ≥37.8º C, 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 infection.
Receipt of systemic glucocorticoids within 1 month of 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 study enrollment.
Previous administration of any H5N1 vaccine.
Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days 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 3 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; 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 test result prior to either 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 use of an analgesic or antipyretic medication within 12 hours prior to first treatment.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Huntsville	Alabama	35802	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21606531	Derived	Langley JM, Risi G, Caldwell M, Gilderman L, Berwald B, Fogarty C, Poling T, Riff D, Baron M, Frenette L, Sheldon E, Collins H, Shepard M, Dionne M, Brune D, Ferguson L, Vaughn D, Li P, Fries L. Dose-sparing H5N1 A/Indonesia/05/2005 pre-pandemic influenza vaccine in adults and elderly adults: a phase III, placebo-controlled, randomized study. J Infect Dis. 2011 Jun 15;203(12):1729-38. doi: 10.1093/infdis/jir172.

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
110464	Statistical Analysis Plan	View IPD

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered 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	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
BG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
BG002	Influenza A (H5N1) >64Y Group	Influenza A (H5N1) >64Y Group Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
BG003	Placebo >64Y Group	Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
BG004	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 Against A/Indonesia/5/2005 (H5N1)

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer < 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.

The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.

Posted

Number

Subjects

At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002	Influenza A (H5N1) >64Y Group	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG003	Placebo >64Y Group	Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Units	Counts
Participants	OG0001571 OG00176 OG002396 OG003

Title

Denominators

Categories

Title	Measurements
	OG0001427 OG0011 OG002293 OG003

Primary

Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

Posted

Number

Subjects

At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002	Influenza A (H5N1) >64Y Group

Primary

Number of Subjects With Any Solicited Local Symptoms.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.

Posted

Number

Subjects

During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002	Influenza A (H5N1) >64Y Group	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Primary

Number of Subjects With Any Solicited General Symptoms.

Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.

The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.

Posted

Number

Subjects

During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002	Influenza A (H5N1) >64Y Group

Primary

Number of Subjects With Any Unsolicited Adverse Events (AEs).

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Posted

Number

Subjects

During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002

Primary

Number of Subjects With Serious Adverse Events (SAEs)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Posted

Number

Subjects

From Day 0 through Day 182 and through Day 379.

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002	Influenza A (H5N1) >64Y Group	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Primary

Number of Subjects With Medically Attended Events (MAEs)

Posted

Number

Subjects

From Day 0 through Day 182 and through Day 364.

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002	Influenza A (H5N1) >64Y Group	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG003

Secondary

Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10

Posted

Number

Subjects

At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

ID	Title	Description
OG000	Influenza A (H5N1) 18-60Y Group	Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Placebo 18-60Y Group	Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002	Influenza A (H5N1) >60Y Group	Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Secondary

Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10

The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6

Posted

Number

Subjects

At Month 6 (Day 182) post Dose 1

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002	Influenza A (H5N1) >64Y Group	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Secondary

Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)

Posted

Number

Subjects

At Month 6 (Day 182) after Dose 1

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Secondary

Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)

Posted

Number

Subjects

At Month 6 (Day 182) after Dose 1

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002	Influenza A (H5N1) >64Y Group	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Secondary

Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.

Posted

Geometric Mean

95% Confidence Interval

Titers

At Month 6 (Day 182) after Dose 1

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG002	Influenza A (H5N1) >64Y Group

Secondary

Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays.

Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.

Posted

Number

Subjects

At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Influenza A (H5N1) >64Y Group	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Secondary

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays

Titers were expressed as Geometric Mean Titers (GMTs).

Posted

Geometric Mean

95% Confidence Interval

Titers

At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

ID	Title	Description
OG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
OG001	Influenza A (H5N1) >64Y Group	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Influenza A (H5N1) 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	24	2,304	2,087	2,304
EG001	Placebo 18-64Y Group	Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	7	768	405	768
EG002	Influenza A (H5N1) >64Y Group	Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	43	1,118	866	1,118
EG003	Placebo >64Y Group	Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	14	371	141	371

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0024 affected1,118 at risk EG0032 affected371 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0023 affected1,118 at risk EG003
Chest pain	General disorders	MedDRA	Non-systematic Assessment	EG0003 affected2,304 at risk EG0010 affected768 at risk EG0022 affected1,118 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0023 affected1,118 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0022 affected1,118 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0023 affected1,118 at risk EG003
Cellulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0011 affected768 at risk EG0021 affected1,118 at risk EG003
Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0002 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0021 affected1,118 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0022 affected1,118 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0022 affected1,118 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA	Non-systematic Assessment	EG0002 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Angina unstable	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Appendicitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0022 affected1,118 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0022 affected1,118 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0022 affected1,118 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Diastolic dysfunction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Diverticulitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0022 affected1,118 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0002 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0022 affected1,118 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0022 affected1,118 at risk EG003
Sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Affective disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Aneurysm	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Biliary dyskinesia	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Biopsy liver normal	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Bronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Caecitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Cardiac disorder	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Cardiomegaly	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Carotid artery dissection	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Carotid artery stenosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Cholangitis suppurative	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Cholecystitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Colitis ischaemic	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Coronary artery occlusion	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Depression	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Diabetic complication	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Enteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Forearm fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Gallbladder disorder	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
HIV test positive	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Hamartoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Hepatitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Herpes zoster	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Hiatus hernia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Hypersensitivity	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Hypertrophic cardiomyopathy	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Hypotension	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Ischaemic stroke	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Left atrial dilatation	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Lymph node cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Lymphoma	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Major depression	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Mania	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Melaena	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Mental disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Migraine	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Mountain sickness acute	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Muscle strain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Nasal septum deviation	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Neonatal respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Pancreatitis	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Pyelonephritis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Radiculitis	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Rectal cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Renal tubular acidosis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Renal vessel disorder	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Seminoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Sick sinus syndrome	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Spinal cord compression	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Syncope	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Synovial cyst	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Tongue carcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Toxic nodular goitre	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Tracheobronchitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0011 affected768 at risk EG0020 affected1,118 at risk EG003
Transplant rejection	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Urinary retention postoperative	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003
Urinary tract infection	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0020 affected1,118 at risk EG003
Viral infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected2,304 at risk EG0010 affected768 at risk EG0021 affected1,118 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pain	General disorders	MedDRA	Systematic Assessment	EG0002,024 affected2,267 at risk EG001171 affected754 at risk EG002784 affected1,109 at risk EG00353 affected368 at risk
Redness	General disorders	MedDRA	Systematic Assessment	EG000181 affected2,267 at risk EG0017 affected754 at risk EG002106 affected1,109 at risk EG003
Swelling	General disorders	MedDRA	Systematic Assessment	EG000241 affected2,267 at risk EG0017 affected754 at risk EG002110 affected1,109 at risk EG003
Fatigue	General disorders	MedDRA	Systematic Assessment	EG000890 affected2,266 at risk EG001189 affected755 at risk EG002258 affected1,109 at risk EG003
Headache	General disorders	MedDRA	Systematic Assessment	EG000932 affected2,266 at risk EG001249 affected755 at risk EG002247 affected1,109 at risk EG003
Joint pain at other location	General disorders	MedDRA	Systematic Assessment	EG000645 affected2,266 at risk EG00197 affected755 at risk EG002208 affected1,109 at risk EG003
Muscle aches	General disorders	MedDRA	Systematic Assessment	EG0001,188 affected2,266 at risk EG001175 affected755 at risk EG002338 affected1,109 at risk EG003
Shivering	General disorders	MedDRA	Systematic Assessment	EG000456 affected2,266 at risk EG00187 affected755 at risk EG002107 affected1,109 at risk EG003
Sweating	General disorders	MedDRA	Systematic Assessment	EG000314 affected2,266 at risk EG00167 affected755 at risk EG00248 affected1,109 at risk EG003
Temperature (Oral)	General disorders	MedDRA	Systematic Assessment	EG000121 affected2,266 at risk EG00132 affected755 at risk EG00235 affected1,109 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG000116 affected2,304 at risk EG00129 affected768 at risk EG00240 affected1,118 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG00091 affected2,304 at risk EG00139 affected768 at risk EG00234 affected1,118 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