Trial Outcomes & Findings for A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine. (NCT NCT00812981)

NCT ID: NCT00812981

Last Updated: 2018-08-20

Results Overview

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 320 participants
• Primary outcome timeframe: At Day 42
• Results posted on: 2018-08-20

Participant Flow

Participant milestones

Measure	1562902A NP Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Overall Study STARTED	160	160
Overall Study COMPLETED	160	159
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	1562902A NP Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Overall Study Other	0	1

Baseline Characteristics

A Study for Evaluation of GSK Biologicals' Pandemic Influenza Vaccine.

Baseline characteristics by cohort

Measure	1562902A NP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	Total n=320 Participants Total of all reporting groups
Age, Continuous	31.30 Years STANDARD_DEVIATION 7.95 • n=5 Participants	32.60 Years STANDARD_DEVIATION 9.10 • n=7 Participants	31.95 Years STANDARD_DEVIATION 8.56 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	83 Participants n=7 Participants	163 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	77 Participants n=7 Participants	157 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East-Asian heritage	160 Participants n=5 Participants	160 Participants n=7 Participants	320 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strain assessed was A/Indonesia/05/2005.

Outcome measures

Measure	1562902A NP Group n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Titers for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies	739.5 Titers Interval 667.8 to 818.8	621.7 Titers Interval 542.9 to 712.0

SECONDARY outcome

Timeframe: At Day 0 and Day 180

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Measure	1562902A NP Group n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Titers for Serum H5N1 HI Antibodies A/Indonesia/05/2005, Day 0	5.0 Titers Interval 5.0 to 5.0	5.1 Titers Interval 5.0 to 5.2
Titers for Serum H5N1 HI Antibodies A/Indonesia/05/2005, Day 180	51.9 Titers Interval 45.1 to 59.7	33.0 Titers Interval 28.0 to 39.0
Titers for Serum H5N1 HI Antibodies A/Vietnam/1194/2004, Day 0	5.1 Titers Interval 4.9 to 5.3	5.2 Titers Interval 5.0 to 5.5
Titers for Serum H5N1 HI Antibodies A/Vietnam/1194/2004, Day 180	12.6 Titers Interval 10.8 to 14.8	8.4 Titers Interval 7.3 to 9.5

SECONDARY outcome

Timeframe: At Days 0, 42 and 180

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

The cut-off values for the humoral immune response in terms of H5N1 HI antibodies were equal to or above (≥) 1:10. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Measure	1562902A NP Group n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value A/Indonesia/05/2005, Day 0	0 Participants	3 Participants
Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value A/Indonesia/05/2005, Day 42	156 Participants	154 Participants
Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value A/Indonesia/05/2005, Day 180	145 Participants	128 Participants
Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value A/Vietnam/1194/2004, Day 0	2 Participants	3 Participants
Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value A/Vietnam/1194/2004, Day 42	149 Participants	140 Participants
Number of Subjects With H5N1 HI Antibody Concentrations Above the Cut-off Value A/Vietnam/1194/2004, Day 180	82 Participants	50 Participants

SECONDARY outcome

Timeframe: At Day 42 and Day 180

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer below (<) 1:10 and a post-vaccination titer equal to or above (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Measure	1562902A NP Group n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Seroconverted Subjects Against Two Strains of Influenza Disease A/Vietnam/1194/2004, Day 180	34 Participants	13 Participants
Number of Seroconverted Subjects Against Two Strains of Influenza Disease A/Indonesia/05/2005, Day 42	156 Participants	153 Participants
Number of Seroconverted Subjects Against Two Strains of Influenza Disease A/Indonesia/05/2005, Day 180	129 Participants	104 Participants
Number of Seroconverted Subjects Against Two Strains of Influenza Disease A/Vietnam/1194/2004, Day 42	143 Participants	126 Participants

SECONDARY outcome

Timeframe: At Day 42 and Day 180

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

The seroconversion factor (SCF) was defined as the fold increase in H5N1 HI antibody GMTs post-vaccination compared to Day 0. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Measure	1562902A NP Group n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=155 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Seroconversion Factor (SCF) for H5N1 HI Antibodies A/Indonesia/05/2005, Day 42	147.9 Fold change Interval 133.6 to 163.8	121.9 Fold change Interval 106.3 to 139.7
Seroconversion Factor (SCF) for H5N1 HI Antibodies A/Indonesia/05/2005, Day 180	10.4 Fold change Interval 9.0 to 11.9	6.5 Fold change Interval 5.5 to 7.6
Seroconversion Factor (SCF) for H5N1 HI Antibodies A/Vietnam/1194/2004, Day 42	15.6 Fold change Interval 13.5 to 17.9	10.8 Fold change Interval 9.1 to 12.7
Seroconversion Factor (SCF) for H5N1 HI Antibodies A/Vietnam/1194/2004, Day 180	2.5 Fold change Interval 2.1 to 2.9	1.6 Fold change Interval 1.4 to 1.8

SECONDARY outcome

Timeframe: At Days 0, 42 and 180

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

A seroprotected subject was defined as a vaccinated subject with a serum HI titer equal to or above (≥) 1:40. The flu strains assessed were A/Indonesia/05/2005 and A/Vietnam/1194/2004.

Outcome measures

Measure	1562902A NP Group n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=156 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Seroprotected Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Day 0	0 Participants	0 Participants
Number of Seroprotected Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Day 42	156 Participants	153 Participants
Number of Seroprotected Subjects for H5N1 HI Antibodies A/Indonesia/05/2005, Day 180	129 Participants	104 Participants
Number of Seroprotected Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Day 0	1 Participants	3 Participants
Number of Seroprotected Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Day 42	144 Participants	127 Participants
Number of Seroprotected Subjects for H5N1 HI Antibodies A/Vietnam/1194/2004, Day 180	34 Participants	16 Participants

SECONDARY outcome

Timeframe: At Days 0, 42 and 180

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was equal to or above (≥) 1:28. The flu strain assessed was A/Vietnam/1194/2004.

Outcome measures

Measure	1562902A NP Group n=58 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=60 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease A/Vietnam/1194/2004, Day 0	189.1 Titers Interval 149.8 to 238.7	166.3 Titers Interval 135.4 to 204.2
Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease A/Vietnam/1194/2004, Day 42	376.7 Titers Interval 308.2 to 460.4	359.2 Titers Interval 320.9 to 402.0
Titers for Serum Neutralising Antibodies Against A/Vietnam/1194/2004 Strain of Influenza Disease A/Vietnam/1194/2004, Day 180	184.5 Titers Interval 151.6 to 224.6	197.3 Titers Interval 159.6 to 244.0

SECONDARY outcome

Timeframe: At Days 0, 42 and 180

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

Seropositivity cut-off values assessed were equal to or above (≥) 1:28 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/Vietnam/1194/2004.

Outcome measures

Measure	1562902A NP Group n=58 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=60 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value A/Vietnam/1194/2004, Day 0	56 Participants	59 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value A/Vietnam/1194/2004, Day 42	57 Participants	59 Participants
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value A/Vietnam/1194/2004, Day 180	57 Participants	59 Participants

SECONDARY outcome

Timeframe: At Day 42 and Day 180

Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables were available.

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:28 and a post-vaccination titer ≥ 1:56 or a pre-vaccination titer ≥ 1:28 and at least a four-fold increase in post-vaccination titer. The flu strain assessed was A/Vietnam/1194/2004.

Outcome measures

Measure	1562902A NP Group n=58 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=59 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Seroconverted Subjects for Neutralizing Antibodies A/Vietnam/1194/2004, Day 42	15 Participants	13 Participants
Number of Seroconverted Subjects for Neutralizing Antibodies A/Vietnam/1194/2004, Day 180	7 Participants	9 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available and who had the symptom sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Outcome measures

Measure	1562902A NP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=159 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Across doses	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 1	141 Participants	137 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 1	9 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 1	3 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 1	13 Participants	14 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Dose 2	137 Participants	133 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Dose 2	9 Participants	4 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Dose 2	4 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Dose 2	17 Participants	12 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Dose 2	0 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain, Across doses	152 Participants	146 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain, Across doses	12 Participants	8 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness, Across doses	4 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling, Across doses	21 Participants	19 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling, Across doses	0 Participants	2 Participants

SECONDARY outcome

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom safety data were available and who had the symptom sheet filled in.

Assessed solicited general symptoms were arthralgia, fatigue, headache, myalgia, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	1562902A NP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=159 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Across doses	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Across doses	16 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Across doses	110 Participants	101 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Across doses	8 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Across doses	109 Participants	101 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Across doses	16 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia, Dose 1	10 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Dose 1	10 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 1	62 Participants	68 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 1	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 1	60 Participants	65 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 1	31 Participants	43 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 1	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 1	27 Participants	40 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 1	90 Participants	78 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 1	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 1	88 Participants	75 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 1	2 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 1	2 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 1	9 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 1	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 1	9 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 1	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 1	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 1	0 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia, Dose 2	27 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Dose 2	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Dose 2	26 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose 2	87 Participants	82 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Dose 2	8 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose 2	87 Participants	82 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose 2	51 Participants	49 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Dose 2	4 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose 2	51 Participants	49 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose 2	67 Participants	62 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Myalgia, Dose 2	7 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose 2	66 Participants	62 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose 2	16 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Shivering, Dose 2	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose 2	16 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Dose 2	11 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Dose 2	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Dose 2	11 Participants	10 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose 2	10 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Dose 2	1 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose 2	10 Participants	12 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Arthralgia, Across doses	32 Participants	33 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Arthralgia, Across doses	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Arthralgia, Across doses	31 Participants	32 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Across doses	104 Participants	99 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fatigue, Across doses	9 Participants	6 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Across doses	102 Participants	98 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Across doses	59 Participants	68 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Headache, Across doses	4 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Across doses	59 Participants	67 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Sweating, Across doses	16 Participants	18 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Sweating, Across doses	0 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Sweating, Across doses	16 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Across doses	10 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Fever, Across doses	1 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Across doses	10 Participants	16 Participants

SECONDARY outcome

Timeframe: From Day 0 up to 51 days after the first vaccination

Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Outcome measures

Measure	1562902A NP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Subjects With Any Adverse Events of Specific Interest (AESIs)	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 up to Day 180)

Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.

An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.

Outcome measures

Measure	1562902A NP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Subjects With Any AESIs	1 Participants	0 Participants

SECONDARY outcome

Timeframe: During the 21-day follow-up period after the first vaccination and 30-day follow-up period after the second vaccination

Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Measure	1562902A NP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	49 Participants	53 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	4 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	15 Participants	12 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 up to Day 180)

Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Measure	1562902A NP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	54 Participants	62 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	5 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	15 Participants	12 Participants

SECONDARY outcome

Timeframe: From Day 0 up to Day 51

Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	1562902A NP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Subjects With Serious Adverse Events (SAEs)	3 Participants	0 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Day 0 up to Day 180)

Population: The analysis was performed on the Total Vaccinated Cohort which included all vaccinated subjects for whom safety data were available.

SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	1562902A NP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=160 Participants Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Number of Subjects With SAEs	4 Participants	2 Participants

Adverse Events

1562902A NP Group

Serious events: 4 serious events

Other events: 155 other events

Deaths: 0 deaths

1562902A CP Group

Serious events: 2 serious events

Other events: 150 other events

Deaths: 0 deaths

Serious adverse events

Measure	1562902A NP Group n=160 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=160 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
Renal and urinary disorders Calculus urinary	0.62% 1/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial cancer stage II	0.62% 1/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
Skin and subcutaneous tissue disorders Erythema	0.62% 1/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
Gastrointestinal disorders Gastritis	0.00% 0/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	0.62% 1/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Gastroenteritis	0.00% 0/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	0.62% 1/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
Injury, poisoning and procedural complications Injury	0.62% 1/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	0.00% 0/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).

Other adverse events

Measure	1562902A NP Group n=160 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.	1562902A CP Group n=160 participants at risk Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
General disorders Pain	95.0% 152/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	91.2% 146/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Swelling	13.1% 21/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	11.9% 19/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Arthralgia	20.0% 32/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	20.6% 33/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Fatigue	65.0% 104/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	61.9% 99/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Headache	36.9% 59/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	42.5% 68/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Myalgia	68.8% 110/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	63.1% 101/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Shivering	10.0% 16/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	8.8% 14/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Sweating	10.0% 16/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	11.2% 18/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
General disorders Fever	6.2% 10/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	10.0% 16/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
Infections and infestations Nasopharyngitis	12.5% 20/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	16.9% 27/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	5.6% 9/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).	4.4% 7/160 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs and SAEs: during the entire study period (from Day 0 up to Day 180).

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