Trial Outcomes & Findings for Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations (NCT NCT00963157)

NCT ID: NCT00963157

Last Updated: 2014-12-24

Results Overview

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 789 participants
• Primary outcome timeframe: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination
• Results posted on: 2014-12-24

Participant Flow

Participants were healthy adults age 18 and older recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 24Sep2009 and 16Nov2009.

Participant milestones

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Overall Study STARTED	156	163	160	157	153
Overall Study COMPLETED	151	159	155	150	151
Overall Study NOT COMPLETED	5	4	5	7	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sanofi H1N1 Influenza Vaccine Administered at Different Dose Levels With and Without AS03 Adjuvant in Healthy Adult and Elderly Populations

Baseline characteristics by cohort

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=156 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=163 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=160 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=157 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=153 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	Total n=789 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	107 Participants n=5 Participants	111 Participants n=7 Participants	110 Participants n=5 Participants	109 Participants n=4 Participants	107 Participants n=21 Participants	544 Participants n=10 Participants
Age, Categorical >=65 years	49 Participants n=5 Participants	52 Participants n=7 Participants	50 Participants n=5 Participants	48 Participants n=4 Participants	46 Participants n=21 Participants	245 Participants n=10 Participants
Age, Continuous	51.3 years STANDARD_DEVIATION 17.6 • n=5 Participants	51.7 years STANDARD_DEVIATION 18.0 • n=7 Participants	51.6 years STANDARD_DEVIATION 17.8 • n=5 Participants	50.1 years STANDARD_DEVIATION 18.3 • n=4 Participants	52.1 years STANDARD_DEVIATION 18.6 • n=21 Participants	51.4 years STANDARD_DEVIATION 18.0 • n=10 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	84 Participants n=7 Participants	93 Participants n=5 Participants	85 Participants n=4 Participants	72 Participants n=21 Participants	423 Participants n=10 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	79 Participants n=7 Participants	67 Participants n=5 Participants	72 Participants n=4 Participants	81 Participants n=21 Participants	366 Participants n=10 Participants
Region of Enrollment United States	156 participants n=5 Participants	163 participants n=7 Participants	160 participants n=5 Participants	157 participants n=4 Participants	153 participants n=21 Participants	789 participants n=10 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to an eligibility deviation. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=106 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=110 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=110 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=107 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=107 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine	84 Participants	95 Participants	62 Participants	94 Participants	80 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=105 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=109 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=105 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=104 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=105 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	90 Participants	96 Participants	72 Participants	96 Participants	86 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 8 days after the first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected are included. One participant was excluded due to influenza-like illness. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=49 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=52 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=50 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=47 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=46 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine	24 Participants	30 Participants	17 Participants	34 Participants	21 Participants

PRIMARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=48 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=52 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=48 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=45 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=44 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	32 Participants	37 Participants	19 Participants	37 Participants	24 Participants

PRIMARY outcome

Timeframe: Day 0 through Day 365 after the last vaccination

Population: All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=156 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=163 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=160 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=157 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=153 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 8-10 days after first vaccination

Population: Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.

Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=151 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=159 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=159 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=151 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=149 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination Prothrombin time	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination Partial thromboplastin time	3 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination Platelets	1 Participants	3 Participants	2 Participants	2 Participants	6 Participants
Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination White blood cells	3 Participants	6 Participants	8 Participants	7 Participants	12 Participants
Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination Neutrophils	2 Participants	3 Participants	5 Participants	3 Participants	8 Participants
Number of Participants With Hematology Laboratory Adverse Events After the First Vaccination Lymphocytes	3 Participants	1 Participants	5 Participants	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 8-10 days after second vaccination

Population: Participants who received at least the first vaccination and had blood collection at the timepoint are included. Analyses are as treated.

Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: prothrombin time (AE >12.6 seconds), partial thromboplastin time (>40.7 seconds), platelets (>=401,000 or <=129,000 cells/square millimeter), white blood cells (>10,800 or <3800 cells/microliter), neutrophils (>8000 or <1800 cells/microliter), and lymphocytes(>4100 or <850 cells/microliter). These parameters were not evaluated prior to enrollment as an assessment of eligibility.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=150 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=158 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=155 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=155 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=147 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination Prothrombin time	1 Participants	2 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination Partial thromboplastin time	4 Participants	3 Participants	0 Participants	3 Participants	3 Participants
Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination Platelets	3 Participants	2 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination White blood cells	8 Participants	5 Participants	9 Participants	8 Participants	9 Participants
Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination Neutrophils	8 Participants	5 Participants	2 Participants	5 Participants	7 Participants
Number of Participants With Hematology Laboratory Adverse Events After the Second Vaccination Lymphocytes	4 Participants	0 Participants	3 Participants	1 Participants	4 Participants

PRIMARY outcome

Timeframe: 8-10 days after first vaccination

Population: Participants who received the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.

Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=155 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=161 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=160 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=156 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=153 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination Sodium	0 Participants	1 Participants	1 Participants	2 Participants	3 Participants
Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination Potassium	2 Participants	1 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination Creatinine	5 Participants	6 Participants	4 Participants	2 Participants	3 Participants
Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination Alanine transaminase	0 Participants	1 Participants	3 Participants	1 Participants	2 Participants
Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination Albumin	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Laboratory Adverse Events After the First Vaccination Total protein	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 8-10 days after second vaccination

Population: Participants who received at least the first vaccination and had blood collected with results reported at the timepoint are included. Analyses are as treated.

Blood was drawn 8-10 days after vaccination to assess laboratory parameters at a central laboratory. Adverse events (AE) were any values that were Grade 1 or greater for the following parameters: sodium (AE >146 or <135 mEq/L), potassium (>5.3 or <3.5 mEq/L), creatinine (>1.4 mg/dL), Alanine transaminase (>52.7 U/L), Albumin (<3.2 g/dL), and total protein (<6.0 g/dL participants age 18-64 years, <5.8 g/dL participants age 65 years and older). These parameters were not evaluated prior to enrollment as an assessment of eligibility.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=150 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=158 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=154 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=153 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=147 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination Sodium	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination Potassium	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination Creatinine	2 Participants	3 Participants	3 Participants	0 Participants	3 Participants
Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination Alanine transaminase	1 Participants	1 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination Albumin	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Chemistry Laboratory Adverse Events After the Second Vaccination Total protein	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first vaccination

Population: Participants who received the first vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=156 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=163 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=160 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=157 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=153 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Feverishness	15 Participants	18 Participants	5 Participants	22 Participants	10 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Malaise	42 Participants	41 Participants	29 Participants	44 Participants	32 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Myalgia	32 Participants	43 Participants	13 Participants	45 Participants	24 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Headache	40 Participants	38 Participants	35 Participants	35 Participants	38 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Nausea	12 Participants	9 Participants	7 Participants	12 Participants	10 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Chills	17 Participants	15 Participants	5 Participants	12 Participants	12 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Arthralgia	13 Participants	11 Participants	4 Participants	18 Participants	9 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination Shivering	7 Participants	9 Participants	3 Participants	7 Participants	5 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second vaccination

Population: Participants who received the second vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, nausea, chills, arthralgia, and shivering for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=147 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=151 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=151 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=147 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=140 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Feverishness	27 Participants	25 Participants	6 Participants	32 Participants	8 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Malaise	47 Participants	41 Participants	17 Participants	40 Participants	19 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Myalgia	38 Participants	39 Participants	10 Participants	35 Participants	14 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Headache	35 Participants	47 Participants	27 Participants	31 Participants	21 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Nausea	16 Participants	10 Participants	5 Participants	10 Participants	5 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Chills	19 Participants	18 Participants	3 Participants	20 Participants	5 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Arthralgia	11 Participants	17 Participants	6 Participants	13 Participants	9 Participants
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination Shivering	14 Participants	10 Participants	3 Participants	16 Participants	2 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first vaccination

Population: Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=156 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=163 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=159 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=156 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=153 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Reporting Fever After the First Vaccination	2 Participants	4 Participants	0 Participants	3 Participants	0 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second vaccination

Population: Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=147 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=151 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=151 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=147 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=140 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Reporting Fever After the Second Vaccination	8 Participants	4 Participants	0 Participants	6 Participants	0 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first vaccination

Population: Participants who received the first vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=156 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=163 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=160 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=157 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=153 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination Pain	90 Participants	96 Participants	25 Participants	90 Participants	35 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination Tenderness	122 Participants	130 Participants	37 Participants	115 Participants	55 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination Swelling	33 Participants	28 Participants	20 Participants	31 Participants	27 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second vaccination

Population: Participants who received the second vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=147 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=151 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=151 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=147 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=140 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination Pain	73 Participants	82 Participants	16 Participants	66 Participants	28 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination Tenderness	104 Participants	112 Participants	37 Participants	100 Participants	51 Participants
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination Swelling	26 Participants	19 Participants	24 Participants	27 Participants	20 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post first vaccination

Population: Participants who received the first vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=156 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=163 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=160 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=157 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=153 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination Redness	41 Participants	36 Participants	33 Participants	44 Participants	40 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination Swelling	36 Participants	30 Participants	22 Participants	32 Participants	28 Participants

PRIMARY outcome

Timeframe: Within 8 days (Day 0-7) post second vaccination

Population: Participants who received the second vaccination are included. Analyses are as treated.

Participants maintained a memory aid to record daily the occurrence of local reactions of redness and swelling for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=147 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=151 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=151 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=147 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=140 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination Redness	28 Participants	29 Participants	30 Participants	40 Participants	30 Participants
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination Swelling	27 Participants	17 Participants	25 Participants	30 Participants	23 Participants

PRIMARY outcome

Timeframe: Day 8 after the first vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to eligibility deviation. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=106 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=110 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=110 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=107 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=107 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine	91 Participants	96 Participants	67 Participants	98 Participants	82 Participants

PRIMARY outcome

Timeframe: Day 21 after the first vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=105 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=109 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=105 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=104 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=105 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	95 Participants	97 Participants	78 Participants	99 Participants	87 Participants

PRIMARY outcome

Timeframe: Day 8 after the first vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 8 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=49 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=52 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=50 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=47 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=46 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the First Dose of H1N1 Vaccine	26 Participants	36 Participants	25 Participants	38 Participants	25 Participants

PRIMARY outcome

Timeframe: Day 21 after the first vaccination

Population: Participants who received the H1N1 vaccination and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=48 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=52 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=48 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=45 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=44 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine	34 Participants	42 Participants	27 Participants	40 Participants	27 Participants

SECONDARY outcome

Timeframe: Day 8 after the second vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=101 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=103 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=101 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=99 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=99 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine	98 Participants	100 Participants	83 Participants	96 Participants	82 Participants

SECONDARY outcome

Timeframe: Day 21 after the second vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=100 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=103 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=101 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=99 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=96 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	98 Participants	100 Participants	80 Participants	97 Participants	79 Participants

SECONDARY outcome

Timeframe: Day 180 after the second vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=98 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=103 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=99 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=96 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=97 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine	90 Participants	87 Participants	66 Participants	83 Participants	69 Participants

SECONDARY outcome

Timeframe: Day 270 after the second vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=90 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=100 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=98 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=92 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=96 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine	71 Participants	71 Participants	58 Participants	71 Participants	62 Participants

SECONDARY outcome

Timeframe: Day 8 after the second vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 8 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=44 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=47 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=46 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=41 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=37 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine	37 Participants	43 Participants	29 Participants	39 Participants	23 Participants

SECONDARY outcome

Timeframe: Day 21 after the second vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 21 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=44 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=47 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=46 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=40 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=37 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	36 Participants	44 Participants	29 Participants	38 Participants	25 Participants

SECONDARY outcome

Timeframe: Day 180 after the second vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 180 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=44 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=47 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=46 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=40 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=36 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine	29 Participants	36 Participants	26 Participants	36 Participants	18 Participants

SECONDARY outcome

Timeframe: Day 270 after the second vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from all participants 270 days after second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=43 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=47 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=42 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=40 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=36 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine	21 Participants	30 Participants	16 Participants	30 Participants	13 Participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=101 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=103 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=101 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=99 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=99 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine	95 Participants	98 Participants	79 Participants	93 Participants	80 Participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to eligibility deviation, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=100 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=103 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=101 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=99 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=96 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	95 Participants	99 Participants	76 Participants	95 Participants	78 Participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=98 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=103 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=99 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=96 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=97 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine	82 Participants	83 Participants	56 Participants	79 Participants	65 Participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. Two participants were excluded due to eligibility deviations, one due to receipt of the wrong second dose, and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=90 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=100 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=98 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=92 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=96 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine	65 Participants	69 Participants	49 Participants	66 Participants	55 Participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination and 8 days after the second H1N1 vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected are included. One participant was excluded due to influenza-like illness and one due to receipt of off-study vaccine. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 8 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=44 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=47 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=46 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=41 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=37 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 8 Days Following the Second Dose of H1N1 Vaccine	34 Participants	39 Participants	23 Participants	35 Participants	21 Participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination and 21 days after the second H1N1 vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 7 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=44 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=47 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=46 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=40 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=37 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine	33 Participants	41 Participants	23 Participants	36 Participants	23 Participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination and 180 days after the second H1N1 vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=44 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=47 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=46 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=40 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=36 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine	25 Participants	31 Participants	21 Participants	29 Participants	15 Participants

SECONDARY outcome

Timeframe: Day 0 prior to vaccination and 270 days after the second H1N1 vaccination

Population: Participants who received both H1N1 vaccinations and from whom blood was collected within 14 days of the window are included. One participant was excluded due to influenza-like illness and two due to receipt of off-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 270 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 270 titer was an increase by 4-fold or more.

Outcome measures

Measure	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=43 Participants Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=47 Participants Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=42 Participants Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=40 Participants Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=36 Participants Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 270 Days Following the Second Dose of H1N1 Vaccine	19 Participants	23 Participants	12 Participants	22 Participants	11 Participants

Adverse Events

7.5 mcg H1N1 Vaccine + AS03 Adjuvant

Serious events: 7 serious events

Other events: 157 other events

Deaths: 0 deaths

3.75 mcg H1N1 Vaccine + AS03 Adjuvant

Serious events: 6 serious events

Other events: 147 other events

Deaths: 0 deaths

7.5 mcg H1N1 Vaccine Unadjuvanted

Serious events: 12 serious events

Other events: 124 other events

Deaths: 0 deaths

15 mcg H1N1 Vaccine + AS03 Adjuvant

Serious events: 8 serious events

Other events: 146 other events

Deaths: 0 deaths

15 mcg H1N1 Vaccine Unadjuvanted

Serious events: 8 serious events

Other events: 130 other events

Deaths: 0 deaths

Serious adverse events

Measure	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=163 participants at risk Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=156 participants at risk Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=160 participants at risk Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=157 participants at risk Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=153 participants at risk Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/156 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Infections and infestations Appendicitis	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/156 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/156 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Psychiatric disorders Major depression	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/156 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/156 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/157 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/156 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/156 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/156 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Infections and infestations Urinary tract infection	0.61% 1/163 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer metastatic	0.61% 1/163 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Blood and lymphatic system disorders Anaemia	0.61% 1/163 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Infections and infestations Pneumonia	0.61% 1/163 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Ischaemic stroke	0.61% 1/163 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Psychiatric disorders Mental status changes	0.61% 1/163 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.61% 1/163 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Surgical and medical procedures Hysterectomy	0.61% 1/163 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Cardiac disorders Sick sinus syndrome	0.61% 1/163 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Grand mal convulsion	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Surgical and medical procedures Gastric bypass	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Aqueductal stenosis	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Infections and infestations Pulmonary tuberculosis	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Cardiac disorders Atrial fibrillation	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Infections and infestations Cellulitis	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Cervical myelopathy	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Renal and urinary disorders Bladder prolapse	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.62% 1/160 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Surgical and medical procedures Spinal laminectomy	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/157 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/157 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Injury, poisoning and procedural complications Respiratory fume inhalation disorder	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/157 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/157 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Gastrointestinal disorders Colitis	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/157 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Cardiac disorders Supraventricular tachycardia	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/157 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/157 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Presyncope	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.64% 1/157 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Cardiac disorders Aortic valve incompetence	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.65% 1/153 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Surgical and medical procedures Atrial septal defect repair	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.65% 1/153 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Chest pain	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.65% 1/153 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.65% 1/153 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Cardiac disorders Arrhythmia	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.65% 1/153 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Dementia	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.65% 1/153 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.65% 1/153 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Surgical and medical procedures Implantable defibrillator insertion	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.65% 1/153 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.65% 1/153 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Infections and infestations Haemophilus sepsis	0.00% 0/163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/157 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.65% 1/153 • Number of events 1 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Other adverse events

Measure	7.5 mcg H1N1 Vaccine + AS03 Adjuvant n=163 participants at risk Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	3.75 mcg H1N1 Vaccine + AS03 Adjuvant n=156 participants at risk Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	7.5 mcg H1N1 Vaccine Unadjuvanted n=160 participants at risk Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.	15 mcg H1N1 Vaccine + AS03 Adjuvant n=157 participants at risk Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.	15 mcg H1N1 Vaccine Unadjuvanted n=153 participants at risk Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
Investigations Blood pressure systolic increased	1.8% 3/163 • Number of events 3 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	1.3% 2/156 • Number of events 2 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	1.9% 3/160 • Number of events 3 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	5.1% 8/157 • Number of events 8 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	3.3% 5/153 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Injection site haematoma	2.5% 4/163 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	6.4% 10/156 • Number of events 10 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	5.6% 9/160 • Number of events 10 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	3.2% 5/157 • Number of events 5 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	5.2% 8/153 • Number of events 8 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	4.9% 8/163 • Number of events 10 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	2.6% 4/156 • Number of events 4 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	5.0% 8/160 • Number of events 8 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	1.9% 3/157 • Number of events 3 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	3.9% 6/153 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Infections and infestations Upper respiratory tract infection	10.4% 17/163 • Number of events 18 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	9.6% 15/156 • Number of events 18 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	12.5% 20/160 • Number of events 22 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	10.2% 16/157 • Number of events 17 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	14.4% 22/153 • Number of events 25 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Pyrexia	4.3% 7/163 • Number of events 8 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	5.1% 8/156 • Number of events 10 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/160 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	5.7% 9/157 • Number of events 9 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	0.00% 0/153 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Feeling hot	21.5% 35/163 • Number of events 43 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	22.4% 35/156 • Number of events 42 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	6.9% 11/160 • Number of events 11 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	28.0% 44/157 • Number of events 54 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	9.8% 15/153 • Number of events 18 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Malaise	41.1% 67/163 • Number of events 82 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	42.3% 66/156 • Number of events 89 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	23.1% 37/160 • Number of events 46 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	38.9% 61/157 • Number of events 84 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	28.8% 44/153 • Number of events 51 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Musculoskeletal and connective tissue disorders Myalgia	41.1% 67/163 • Number of events 82 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	35.3% 55/156 • Number of events 70 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	13.8% 22/160 • Number of events 23 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	38.2% 60/157 • Number of events 80 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	20.9% 32/153 • Number of events 38 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Nervous system disorders Headache	41.7% 68/163 • Number of events 85 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	37.8% 59/156 • Number of events 75 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	33.8% 54/160 • Number of events 62 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	29.9% 47/157 • Number of events 66 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	30.1% 46/153 • Number of events 59 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Gastrointestinal disorders Nausea	11.7% 19/163 • Number of events 19 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	14.1% 22/156 • Number of events 28 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	6.9% 11/160 • Number of events 12 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	12.1% 19/157 • Number of events 22 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	9.8% 15/153 • Number of events 15 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
Musculoskeletal and connective tissue disorders Arthralgia	16.6% 27/163 • Number of events 28 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	14.1% 22/156 • Number of events 24 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	5.6% 9/160 • Number of events 10 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	16.6% 26/157 • Number of events 31 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	9.2% 14/153 • Number of events 18 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Chills	11.7% 19/163 • Number of events 19 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	10.9% 17/156 • Number of events 21 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	3.8% 6/160 • Number of events 6 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	14.0% 22/157 • Number of events 23 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	4.6% 7/153 • Number of events 7 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Injection site pain	71.8% 117/163 • Number of events 178 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	64.7% 101/156 • Number of events 163 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	20.6% 33/160 • Number of events 41 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	65.0% 102/157 • Number of events 156 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	30.7% 47/153 • Number of events 63 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Tenderness	86.5% 141/163 • Number of events 242 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	88.5% 138/156 • Number of events 226 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	32.5% 52/160 • Number of events 74 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	81.5% 128/157 • Number of events 215 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	45.8% 70/153 • Number of events 106 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Injection site erythema	31.9% 52/163 • Number of events 65 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	34.6% 54/156 • Number of events 69 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	31.9% 51/160 • Number of events 63 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	40.1% 63/157 • Number of events 84 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	34.6% 53/153 • Number of events 70 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Injection site swelling (functional grading)	22.1% 36/163 • Number of events 47 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	29.5% 46/156 • Number of events 59 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	20.6% 33/160 • Number of events 44 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	29.9% 47/157 • Number of events 58 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	24.2% 37/153 • Number of events 47 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.
General disorders Injection site swelling (measured)	24.5% 40/163 • Number of events 47 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	30.8% 48/156 • Number of events 63 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	23.1% 37/160 • Number of events 47 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	32.5% 51/157 • Number of events 62 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.	27.5% 42/153 • Number of events 51 • Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 365 days after last vaccination. For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Additional Information

Lisa Jackson, MD, MPH

Group Health Research Institute

Phone: 206-442-5216

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60