Trial Outcomes & Findings for Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults (NCT NCT00510874)

NCT ID: NCT00510874

Last Updated: 2018-08-17

Results Overview

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 on the specified day.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 780 participants
• Primary outcome timeframe: At Day 42
• Results posted on: 2018-08-17

Participant Flow

Participant milestones

Measure	Pumarix Formulation 1 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Study STARTED	78	152	151	151	148	50	50
Overall Study COMPLETED	75	148	150	148	141	50	49
Overall Study NOT COMPLETED	3	4	1	3	7	0	1

Reasons for withdrawal

Measure	Pumarix Formulation 1 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Overall Study Withdrawal by Subject	1	1	0	0	3	0	0
Overall Study Lost to Follow-up	2	3	1	3	4	0	1

Baseline Characteristics

Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults

Baseline characteristics by cohort

Measure	Pumarix Formulation 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=152 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=148 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Total n=780 Participants Total of all reporting groups
Age, Continuous	38.5 Years STANDARD_DEVIATION 12.85 • n=5 Participants	38.1 Years STANDARD_DEVIATION 12.10 • n=7 Participants	39.0 Years STANDARD_DEVIATION 12.59 • n=5 Participants	38.7 Years STANDARD_DEVIATION 11.25 • n=4 Participants	38.7 Years STANDARD_DEVIATION 12.20 • n=21 Participants	39.2 Years STANDARD_DEVIATION 12.21 • n=8 Participants	39.9 Years STANDARD_DEVIATION 13.18 • n=8 Participants	38.8 Years STANDARD_DEVIATION 12.22 • n=24 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	83 Participants n=7 Participants	87 Participants n=5 Participants	100 Participants n=4 Participants	78 Participants n=21 Participants	32 Participants n=8 Participants	24 Participants n=8 Participants	449 Participants n=24 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	69 Participants n=7 Participants	64 Participants n=5 Participants	51 Participants n=4 Participants	70 Participants n=21 Participants	18 Participants n=8 Participants	26 Participants n=8 Participants	331 Participants n=24 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.

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 on the specified day.

Outcome measures

Measure	Pumarix Formulation 1 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=144 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=146 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=140 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=142 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=49 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	13 Participants	140 Participants	131 Participants	135 Participants	131 Participants	47 Participants	42 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs).

Outcome measures

Measure	Pumarix Formulation 1 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=144 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=146 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=140 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=142 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=49 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	10.5 Titers Interval 8.2 to 13.5	464.7 Titers Interval 383.4 to 563.4	320.7 Titers Interval 246.9 to 416.6	480.3 Titers Interval 390.5 to 590.7	347.7 Titers Interval 272.0 to 444.5	331.6 Titers Interval 217.4 to 505.6	173.9 Titers Interval 105.6 to 286.3

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.

Outcome measures

Measure	Pumarix Formulation 1 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=144 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=146 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=140 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=142 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=49 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease.	13 Participants	140 Participants	131 Participants	135 Participants	131 Participants	47 Participants	42 Participants

PRIMARY outcome

Timeframe: Within the 7-day follow-up period (Days 0-6) after any vaccination

Population: 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.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any solicited local symptoms regardless of their intensity grade. Any redness and swelling were ≥ 20 millimeters (mm).

Outcome measures

Measure	Pumarix Formulation 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=152 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=148 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Number of Subjects With Solicited Local Symptoms. Any Pain	18 Participants	133 Participants	130 Participants	139 Participants	124 Participants	48 Participants	42 Participants
Number of Subjects With Solicited Local Symptoms. Any Redness	0 Participants	7 Participants	2 Participants	9 Participants	6 Participants	1 Participants	0 Participants
Number of Subjects With Solicited Local Symptoms. Any Swelling	0 Participants	12 Participants	10 Participants	21 Participants	9 Participants	4 Participants	0 Participants

PRIMARY outcome

Timeframe: Within the 7-day follow-up period (Days 0-6) after any vaccination

Population: 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.

Assessed solicited general symptoms were fatigue, headache, joint pain at other location (joint pain), muscle aches, shivering, sweating and fever. Fever was defined as oral temperature (≥) 38 degrees Celsius (°C). Any = occurrence of any solicited general symptoms regardless of intensity grade or relationship to vaccination.

Outcome measures

Measure	Pumarix Formulation 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=152 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=148 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Number of Subjects With Solicited General Symptoms. Any Fatigue	16 Participants	64 Participants	50 Participants	67 Participants	69 Participants	15 Participants	15 Participants
Number of Subjects With Solicited General Symptoms. Any Headache	25 Participants	71 Participants	61 Participants	66 Participants	61 Participants	11 Participants	19 Participants
Number of Subjects With Solicited General Symptoms. Any Joint Pain	12 Participants	49 Participants	36 Participants	53 Participants	39 Participants	11 Participants	11 Participants
Number of Subjects With Solicited General Symptoms. Any Muscle Aches	15 Participants	74 Participants	64 Participants	86 Participants	63 Participants	19 Participants	21 Participants
Number of Subjects With Solicited General Symptoms. Any Shivering	4 Participants	18 Participants	21 Participants	27 Participants	17 Participants	8 Participants	6 Participants
Number of Subjects With Solicited General Symptoms. Any Sweating	6 Participants	23 Participants	12 Participants	24 Participants	21 Participants	5 Participants	1 Participants
Number of Subjects With Solicited General Symptoms. Any Fever	0 Participants	4 Participants	3 Participants	12 Participants	11 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 0 to 182

Population: 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.

A MAE was defined as any unsolicited symptom that received medical attention such as hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. NOCDs included autoimmune diseases, diabetes mellitus.

Outcome measures

Measure	Pumarix Formulation 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=152 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=148 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). Subjects with MAEs	16 Participants	29 Participants	33 Participants	28 Participants	34 Participants	14 Participants	14 Participants
Number of Subjects With Medically Attended Adverse Events (MAEs) and New Onset Chronic Diseases (NOCDs). Subjects with NOCDs	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During the 21-day follow-up period (Days 0-20) after vaccination.

Population: 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.

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.

Outcome measures

Measure	Pumarix Formulation 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=152 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=148 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Number of Subjects With Unsolicited Adverse Events (AEs).	30 Participants	67 Participants	60 Participants	73 Participants	84 Participants	26 Participants	20 Participants

PRIMARY outcome

Timeframe: Between Day 0 and Day 84 after vaccination.

Population: 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.

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.

Outcome measures

Measure	Pumarix Formulation 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=152 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=148 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Number of Subjects With Unsolicited Adverse Events (AEs).	35 Participants	77 Participants	71 Participants	81 Participants	89 Participants	29 Participants	23 Participants

PRIMARY outcome

Timeframe: From Day 0 to 182

Population: 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.

A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or resulted in a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	Pumarix Formulation 1 Group n=78 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=152 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=151 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=148 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Number of Subjects With Any Serious Adverse Events (SAEs).	0 Participants	2 Participants	1 Participants	2 Participants	1 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: At Day 21 and Day 182

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.

Titers are presented as geometric mean titers (GMTs).

Outcome measures

Measure	Pumarix Formulation 1 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=144 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=146 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=140 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=142 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=49 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 21	6.1 Titers Interval 5.2 to 7.1	22.5 Titers Interval 17.8 to 28.6	19.9 Titers Interval 15.7 to 25.3	23.5 Titers Interval 18.3 to 30.3	16.8 Titers Interval 13.5 to 20.9	23.0 Titers Interval 14.8 to 36.0	20.8 Titers Interval 13.9 to 31.3
Titers for Serum HI Antibodies Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 182	5.6 Titers Interval 5.1 to 6.2	27.8 Titers Interval 22.8 to 33.8	22.6 Titers Interval 18.4 to 27.9	26.1 Titers Interval 20.7 to 32.8	22.6 Titers Interval 18.3 to 28.0	32.5 Titers Interval 20.9 to 50.7	20.0 Titers Interval 13.6 to 29.3

SECONDARY outcome

Timeframe: At Days 21 and 182

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.

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 on the specified day.

Outcome measures

Measure	Pumarix Formulation 1 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=144 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=146 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=140 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=142 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=49 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 21	5 Participants	60 Participants	60 Participants	64 Participants	54 Participants	23 Participants	21 Participants
Number of Seroconverted Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 182	2 Participants	77 Participants	66 Participants	67 Participants	62 Participants	24 Participants	23 Participants

SECONDARY outcome

Timeframe: At Days 21 and 182

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.

GMFR was defined as the geometric mean fold increase in serum HI antibody reciprocal titer on the specified study day compared to Day 0.

Outcome measures

Measure	Pumarix Formulation 1 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=144 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=146 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=140 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=142 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=49 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1at Day 21	1.2 Fold increase Interval 1.0 to 1.4	4.5 Fold increase Interval 3.6 to 5.7	4.0 Fold increase Interval 3.1 to 5.1	4.7 Fold increase Interval 3.6 to 6.0	3.3 Fold increase Interval 2.7 to 4.1	4.1 Fold increase Interval 2.7 to 6.2	4.2 Fold increase Interval 2.8 to 6.3
Geometric Mean Fold-rise (GMFR) Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1at Day 182	1.1 Fold increase Interval 1.0 to 1.2	5.6 Fold increase Interval 4.6 to 6.8	4.5 Fold increase Interval 3.7 to 5.6	5.2 Fold increase Interval 4.1 to 6.5	4.5 Fold increase Interval 3.6 to 5.6	5.8 Fold increase Interval 3.7 to 9.1	4.0 Fold increase Interval 2.7 to 5.9

SECONDARY outcome

Timeframe: At Days 0, 21 and 182

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data for the primary outcome variables were available i.e. all subjects had to have at least Day 0 and Day 42 HI titer results for the A/Indonesia/5/05 virus.

A seroprotected subject was defined as a vaccinated subject who had a serum HI antibody reciprocal titer ≥ 1:40 on the specified study day.

Outcome measures

Measure	Pumarix Formulation 1 Group n=75 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=144 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=146 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=140 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=143 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=49 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 Participants Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 21	5 Participants	60 Participants	60 Participants	64 Participants	54 Participants	23 Participants	21 Participants
Number of Seroprotected Subjects Against the A/Indonesia/5/2005 (H5N1) Strain of Influenza Disease. H5N1 at Day 182	2 Participants	77 Participants	66 Participants	68 Participants	63 Participants	26 Participants	23 Participants

Adverse Events

Pumarix Formulation 1 Group

Serious events: 0 serious events

Other events: 45 other events

Deaths: 0 deaths

Pumarix Formulation 2 Group

Serious events: 2 serious events

Other events: 137 other events

Deaths: 0 deaths

Pumarix Formulation 3 Group

Serious events: 1 serious events

Other events: 132 other events

Deaths: 0 deaths

Pandemrix Formulation A Group

Serious events: 2 serious events

Other events: 146 other events

Deaths: 0 deaths

Pandemrix Formulation B Group

Serious events: 1 serious events

Other events: 131 other events

Deaths: 0 deaths

Pumarix Formulation 4 Group

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

Pumarix Formulation 5 Group

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pumarix Formulation 1 Group n=78 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=152 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=151 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=151 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=148 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=50 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
Gastrointestinal disorders Ascites	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.68% 1/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.66% 1/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.68% 1/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
General disorders Chest pain	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.66% 1/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Hepatobiliary disorders Cholelithiasis	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.66% 1/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Infections and infestations Gastroenteritis clostridial	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.68% 1/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Vascular disorders Haematoma	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.68% 1/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Renal and urinary disorders Hydronephrosis	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.68% 1/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.66% 1/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Gastrointestinal disorders Pancreatitis	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.66% 1/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Infections and infestations Pelvic abscess	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.68% 1/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.68% 1/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.66% 1/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Gastrointestinal disorders Rectal perforation	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.68% 1/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.66% 1/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.0% 1/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.

Other adverse events

Measure	Pumarix Formulation 1 Group n=78 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 2 Group n=152 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 3 Group n=151 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation A Group n=151 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pandemrix Formulation B Group n=148 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 4 Group n=50 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).	Pumarix Formulation 5 Group n=50 participants at risk Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
General disorders Pain	23.1% 18/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	87.5% 133/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	86.1% 130/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	92.1% 139/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	83.8% 124/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	96.0% 48/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	84.0% 42/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
General disorders Redness	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	4.6% 7/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	1.3% 2/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	6.0% 9/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	4.1% 6/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.0% 1/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
General disorders Swelling	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	7.9% 12/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	6.6% 10/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	13.9% 21/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	6.1% 9/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	8.0% 4/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
General disorders Fatigue	20.5% 16/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	42.1% 64/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	33.1% 50/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	44.4% 67/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	46.6% 69/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	30.0% 15/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	30.0% 15/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
General disorders Headache	32.1% 25/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	46.7% 71/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	40.4% 61/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	43.7% 66/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	41.2% 61/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	22.0% 11/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	38.0% 19/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
General disorders Joint pain	15.4% 12/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	32.2% 49/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	23.8% 36/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	35.1% 53/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	26.4% 39/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	22.0% 11/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	22.0% 11/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
General disorders Muscle aches	19.2% 15/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	48.7% 74/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	42.4% 64/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	57.0% 86/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	42.6% 63/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	38.0% 19/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	42.0% 21/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
General disorders Shivering	5.1% 4/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	11.8% 18/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	13.9% 21/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	17.9% 27/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	11.5% 17/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	16.0% 8/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	12.0% 6/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
General disorders Sweating	7.7% 6/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	15.1% 23/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	7.9% 12/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	15.9% 24/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	14.2% 21/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	10.0% 5/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.0% 1/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
General disorders Fever	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.6% 4/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.6% 4/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	7.9% 12/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	7.4% 11/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.0% 1/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Gastrointestinal disorders Nausea	3.8% 3/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	7.2% 11/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	4.0% 6/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	4.6% 7/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	3.4% 5/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	4.0% 2/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	6.4% 5/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	3.3% 5/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.6% 4/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	6.6% 10/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	4.7% 7/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Nervous system disorders Headache	3.8% 3/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.6% 4/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.0% 3/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	8.6% 13/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	8.1% 12/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	8.0% 4/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	8.0% 4/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Infections and infestations Upper respiratory tract infection	3.8% 3/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	3.3% 5/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	1.3% 2/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	4.6% 7/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	5.4% 8/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	6.0% 3/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	8.0% 4/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.0% 1/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	8.0% 4/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	0.00% 0/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	6.0% 3/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.0% 1/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.
Infections and infestations Nasopharyngitis	7.7% 6/78 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.6% 4/152 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	9.3% 14/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	6.0% 9/151 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	2.7% 4/148 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	4.0% 2/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.	4.0% 2/50 • Serious Adverse Events = From Days 0-182. Systematically assessed frequent adverse events (AEs) = During the 7 day post vaccination period. Non-systematically assessed frequent AEs= During Days 0-20 and Days 0-84 post vaccination period respectively.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER