Trial Outcomes & Findings for Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old (NCT NCT01730378)

NCT ID: NCT01730378

Last Updated: 2018-09-07

Results Overview

A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 131 participants
• Primary outcome timeframe: At Day 42
• Results posted on: 2018-09-07

Participant Flow

Participant milestones

Measure	Prepandrix Group Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Overall Study STARTED	84	47
Overall Study COMPLETED	83	47
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Prepandrix Group Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old

Baseline characteristics by cohort

Measure	Prepandrix Group n=84 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group n=47 Participants Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.	Total n=131 Participants Total of all reporting groups
Age, Continuous	39.3 Years STANDARD_DEVIATION 10.94 • n=5 Participants	40.4 Years STANDARD_DEVIATION 10.3 • n=7 Participants	39.69 Years STANDARD_DEVIATION 10.69 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants	34 Participants n=7 Participants	95 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	13 Participants n=7 Participants	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.

A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.

Outcome measures

Measure	Prepandrix Group n=81 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.	81 Subjects	—

PRIMARY outcome

Timeframe: At Day 42

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).

Outcome measures

Measure	Prepandrix Group n=81 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.	58.0 Fold increase Interval 48.7 to 69.1	—

PRIMARY outcome

Timeframe: At Day 42

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.

Outcome measures

Measure	Prepandrix Group n=81 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.	81 Subjects	—

PRIMARY outcome

Timeframe: At Day 0 and Day 42

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Antibody titers were expressed as Geometric mean titers (GMTs).

Outcome measures

Measure	Prepandrix Group n=81 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. H5N1, Day 0	5.2 Titer Interval 5.0 to 5.3	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. H5N1, Day 42	300.1 Titer Interval 254.1 to 354.5	—

SECONDARY outcome

Timeframe: At Day 21

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Antibody titers were expressed as Geometric mean titers (GMTs).

Outcome measures

Measure	Prepandrix Group n=81 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.	31.8 Titer Interval 26.2 to 38.7	—

SECONDARY outcome

Timeframe: At Day 0 and Day 21

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.

Outcome measures

Measure	Prepandrix Group n=81 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. H5N1, Day 0	0 Subjects	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group. H5N1, Day 21	37 Subjects	—

SECONDARY outcome

Timeframe: At Day 21

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.

Outcome measures

Measure	Prepandrix Group n=81 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.	37 Subjects	—

SECONDARY outcome

Timeframe: At Day 21

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).

Outcome measures

Measure	Prepandrix Group n=81 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.	6.2 Fold increase Interval 5.1 to 7.5	—

SECONDARY outcome

Timeframe: At Days 0 and 21

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).

Outcome measures

Measure	Prepandrix Group n=40 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H1N1, Day 0	18.3 Titer Interval 12.0 to 27.9	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H1N1, Day 21	425.9 Titer Interval 289.9 to 625.7	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H3N2, Day 0	22.0 Titer Interval 14.7 to 33.0	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H3N2, Day 21	149.2 Titer Interval 108.5 to 205.3	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. Yamagata, Day 0	60.1 Titer Interval 43.0 to 84.0	—
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. Yamagata, Day 21	367.6 Titer Interval 304.7 to 443.4	—

SECONDARY outcome

Timeframe: At Day 21

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).

Outcome measures

Measure	Prepandrix Group n=40 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H1N1	33 Subjects	—
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H3N2	24 Subjects	—
Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. Yamagata	26 Subjects	—

SECONDARY outcome

Timeframe: At Day 21

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).

Outcome measures

Measure	Prepandrix Group n=40 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H1N1	23.3 Fold increase Interval 13.7 to 39.3	—
Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H3N2	6.8 Fold increase Interval 4.3 to 10.7	—
Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. Yamagata	6.1 Fold increase Interval 4.3 to 8.7	—

SECONDARY outcome

Timeframe: At Day 0 and Day 21

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).

Outcome measures

Measure	Prepandrix Group n=40 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H1N1, Day 0	14 Subjects	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H1N1, Day 21	39 Subjects	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H3N2, Day 0	15 Subjects	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. H3N2, Day 21	38 Subjects	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. Yamagata, Day 0	30 Subjects	—
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group. Yamagata, Day 21	40 Subjects	—

SECONDARY outcome

Timeframe: During the 7-day (Day 0-6) period after each vaccination

Population: Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.

Outcome measures

Measure	Prepandrix Group n=84 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group n=47 Participants Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Pain	80 Subjects	32 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain	8 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Redness	27 Subjects	6 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Swelling	16 Subjects	2 Subjects

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period

Population: Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.

Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C

Outcome measures

Measure	Prepandrix Group n=84 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group n=47 Participants Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever (≥ 38.0°C)	2 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever (≥ 39.0°C)	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever	2 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Shivering	32 Subjects	4 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Shivering	3 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue	54 Subjects	14 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue	4 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue	51 Subjects	13 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Headache	38 Subjects	8 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache	4 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Headache	37 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Increased Sweating	28 Subjects	3 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Muscle Aches	62 Subjects	13 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Muscle Aches	6 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Increased Sweating	2 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Muscle Aches	61 Subjects	13 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Increased Sweating	28 Subjects	3 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Joint Pain	30 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Joint Pain	5 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Joint Pain	30 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Shivering	32 Subjects	4 Subjects

SECONDARY outcome

Timeframe: During the entire study period (From Day 0 to Day 182)

Population: Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.

Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

Outcome measures

Measure	Prepandrix Group n=84 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group n=47 Participants Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: During the 21 days (Day 0-20) post-vaccination period

Population: Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Prepandrix Group n=84 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group n=47 Participants Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	28 Subjects	9 Subjects

SECONDARY outcome

Timeframe: During the 84-day (Days 0-83) post vaccination period

Population: Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Prepandrix Group n=84 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group n=47 Participants Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Subjects Reporting Unsolicted AEs	29 Subjects	12 Subjects

SECONDARY outcome

Timeframe: During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group

Population: Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Outcome measures

Measure	Prepandrix Group n=84 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Subjects Any Unsolicited AEs	16 Subjects	—

SECONDARY outcome

Timeframe: During the entire study period (From Day 0 to 182)

Population: Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.

A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	Prepandrix Group n=84 Participants Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group n=47 Participants Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Any SAEs	1 Subjects	0 Subjects
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Related SAEs	0 Subjects	0 Subjects

Adverse Events

Prepandrix Group

Serious events: 1 serious events

Other events: 81 other events

Deaths: 0 deaths

Fluarix Group

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Serious adverse events

Measure	Prepandrix Group n=84 participants at risk Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group n=47 participants at risk Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
Infections and infestations Appendicitis	1.2% 1/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	0.00% 0/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
Reproductive system and breast disorders Endometriosis	1.2% 1/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	0.00% 0/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
Reproductive system and breast disorders Ovarian cyst	1.2% 1/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	0.00% 0/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period

Other adverse events

Measure	Prepandrix Group n=84 participants at risk Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).	Fluarix Group n=47 participants at risk Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
General disorders Pain	95.2% 80/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	68.1% 32/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
General disorders Redness	32.1% 27/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	12.8% 6/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
General disorders Swelling	19.0% 16/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	4.3% 2/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
General disorders Fatigue	64.3% 54/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	29.8% 14/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
General disorders Headache	45.2% 38/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	17.0% 8/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
General disorders Increased Sweating	33.3% 28/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	6.4% 3/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
General disorders Joint Pain	35.7% 30/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	10.6% 5/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
General disorders Muscles Aches	73.8% 62/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	27.7% 13/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
General disorders Shivering	38.1% 32/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	8.5% 4/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
Skin and subcutaneous tissue disorders Pruritus	7.1% 6/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	0.00% 0/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period
Infections and infestations Nasopharyngitis	4.8% 4/84 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period	6.4% 3/47 • Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

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

Restriction type: OTHER