Trial Outcomes & Findings for A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults (NCT NCT04090658)

NCT ID: NCT04090658

Last Updated: 2022-02-25

Results Overview

Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling is scored with a diameter larger than (\>) 20 millimeters (mm).

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination administered at Day 1
• Results posted on: 2022-02-25

Participant Flow

Participant milestones

Measure	RSV_PreF3_AS01B Group Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults

Baseline characteristics by cohort

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.	Total n=40 Participants Total of all reporting groups
Age, Continuous	65.2 Years STANDARD_DEVIATION 5.0 • n=5 Participants	67.2 Years STANDARD_DEVIATION 4.2 • n=7 Participants	66.2 Years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Asian	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination administered at Day 1

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling is scored with a diameter larger than (>) 20 millimeters (mm).

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination Erythema	1 Participants	0 Participants
Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination Pain	17 Participants	1 Participants
Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination Swelling	2 Participants	0 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after second dose of vaccination administered at Day 61

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored with a diameter larger than (>) 20 millimeters (mm).

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Solicited Local AEs After Second Dose of Vaccination Erythema	0 Participants	0 Participants
Number of Subjects With Solicited Local AEs After Second Dose of Vaccination Pain	17 Participants	4 Participants
Number of Subjects With Solicited Local AEs After Second Dose of Vaccination Swelling	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination administered at Day 1

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

Assessed solicited general AEs solicited were: arthralgia; fatigue; fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain); headache; myalgia and shivering.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Solicited General AEs After First Dose of Vaccination Arthralgia	1 Participants	0 Participants
Number of Subjects With Solicited General AEs After First Dose of Vaccination Fatigue	9 Participants	2 Participants
Number of Subjects With Solicited General AEs After First Dose of Vaccination Fever	0 Participants	0 Participants
Number of Subjects With Solicited General AEs After First Dose of Vaccination Gastrointestinal symptoms	1 Participants	1 Participants
Number of Subjects With Solicited General AEs After First Dose of Vaccination Headache	2 Participants	2 Participants
Number of Subjects With Solicited General AEs After First Dose of Vaccination Myalgia	6 Participants	0 Participants
Number of Subjects With Solicited General AEs After First Dose of Vaccination Shivering	1 Participants	0 Participants

PRIMARY outcome

Timeframe: During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after second dose of vaccination administered at Day 61

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

Assessed solicited general AEs solicited are: arthralgia; fatigue; fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); gastrointestinal symptoms including (nausea, vomiting, diarrhea and/or abdominal pain); headache; myalgia and shivering.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Solicited General AEs After Second Dose of Vaccination Arthralgia	5 Participants	0 Participants
Number of Subjects With Solicited General AEs After Second Dose of Vaccination Fatigue	9 Participants	1 Participants
Number of Subjects With Solicited General AEs After Second Dose of Vaccination Fever	4 Participants	0 Participants
Number of Subjects With Solicited General AEs After Second Dose of Vaccination Gastrointestinal symptoms	0 Participants	1 Participants
Number of Subjects With Solicited General AEs After Second Dose of Vaccination Headache	5 Participants	1 Participants
Number of Subjects With Solicited General AEs After Second Dose of Vaccination Myalgia	5 Participants	1 Participants
Number of Subjects With Solicited General AEs After Second Dose of Vaccination Shivering	4 Participants	0 Participants

PRIMARY outcome

Timeframe: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination (across doses)

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Unsolicited AEs After Any Vaccination	7 Participants	6 Participants

PRIMARY outcome

Timeframe: At 7 days after the first vaccine dose (i.e. at Day 8 versus Day 1)

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as below, within or above the normal ranges.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Urea Nitrogen-Above-Within	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 ALT-Above-Above	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 ALT-Within-Within	19 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 AST-Within-Above	0 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 AST-Within-Within	20 Participants	19 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Basophils-Within-Within	20 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Creatinine-Within-Below	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Creatinine-Within-Within	19 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Eosinophils-Below-Below	3 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Eosinophils-Below-Within	2 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Uric Acid-Above-Above	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Eosinophils-Within-Below	2 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Eosinophils-Within-Within	13 Participants	17 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Erythrocytes-Below-Below	0 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Erythrocytes-Within-Below	2 Participants	2 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Erythrocytes-Within-Within	18 Participants	17 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Hemoglobin-Below-Below	0 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Hemoglobin-Within-Below	0 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Hemoglobin-Within-Within	20 Participants	18 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Lymphocytes-Within-Within	20 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Monocytes-Below-Below	2 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Monocytes-Below-Within	1 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Monocytes-Within-Below	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Monocytes-Within-Within	16 Participants	19 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Neutrophils-Below-Below	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Neutrophils-Within-Within	19 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Platelets-Within-Within	20 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Urea Nitrogen-Within-Within	19 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Uric Acid-Above-Within	2 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Uric Acid-Within-Above	1 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Uric Acid-Within-Below	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 Uric Acid-Within-Within	15 Participants	19 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 White Blood Cells-Below-Below	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 White Blood Cells-Below-Within	0 Participants	2 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 White Blood Cells-Within-Below	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1 White Blood Cells-Within-Within	18 Participants	18 Participants

PRIMARY outcome

Timeframe: At 7 days after the second vaccine dose (i.e at Day 68 versus Day 61)

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase [ALT], aspartate aminotransferase [AST], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: <parameter>-<range at baseline>-<range at timing> (e.g. ALT-Within-Within). Ranges level being classified as below, within or above the normal ranges.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Erythrocytes-Within-Within	18 Participants	16 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Hemoglobin-Below-Within	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Platelets-Within-Within	20 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Urea Nitrogen-Within-Within	20 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Uric Acid-Within-Within	17 Participants	18 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 ALT-Within-Within	20 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 AST-Within-Above	0 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 AST-Within-Within	20 Participants	19 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Basophils-Within-Within	20 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Creatinine-Below-Below	0 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Creatinine-Within-Above	0 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Creatinine-Within-Below	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Creatinine-Within-Within	19 Participants	18 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Eosinophils-Below-Within	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Eosinophils-Within-Above	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Eosinophils-Within-Within	18 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Erythrocytes-Below-Below	0 Participants	3 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Erythrocytes-Below-Within	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Erythrocytes-Within-Below	1 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Hemoglobin-Within-Below	0 Participants	2 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Hemoglobin-Within-Within	19 Participants	18 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Lymphocytes-Within-Within	20 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Monocytes-Below-Below	2 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Monocytes-Within-Below	2 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Monocytes-Within-Within	16 Participants	20 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Neutrophils-Below-Below	1 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Neutrophils-Within-Below	0 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Neutrophils-Within-Within	19 Participants	18 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Uric Acid-Above-Above	0 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Uric Acid-Below-Below	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Uric Acid-Within-Above	1 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 Uric Acid-Within-Below	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 White Blood Cells-Below-Below	1 Participants	0 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 White Blood Cells-Below-Within	2 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 White Blood Cells-Within-Below	0 Participants	1 Participants
Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61 White Blood Cells-Within-Within	17 Participants	18 Participants

PRIMARY outcome

Timeframe: During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first vaccination

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination Any adverse event	0 Participants	0 Participants
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination General adverse event	0 Participants	0 Participants
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination Local adverse event	0 Participants	0 Participants

PRIMARY outcome

Timeframe: During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second vaccination

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination Any adverse event	2 Participants	0 Participants
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination General adverse event	1 Participants	0 Participants
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination Local adverse event	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 30 days after the second vaccination (Day 91)

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination	0 Participants	1 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 30 days after the second vaccination (Day 91)

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

pIMDs are 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 etiology

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)

Population: The analysis was performed on the Per Protocol Set (PPS) that included all subjects who received at least 1 dose of the study treatment to which they were randomized and had post-vaccination data, minus subjects with protocol deviations that led to exclusion.

Serological assays for the determination of functional antibodies against RSV-A were performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60). The cut-off of the assay is 18 ED60.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV- Serotype A Day 1	727.3 Titers Interval 445.6 to 1187.3	656 Titers Interval 464.7 to 926.2
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV- Serotype A Day 31	5315 Titers Interval 3452.8 to 8181.5	582.3 Titers Interval 372.1 to 911.2
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV- Serotype A Day 61	4382.8 Titers Interval 2828.1 to 6792.1	646.1 Titers Interval 442.6 to 943.1
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV- Serotype A Day 91	4605.2 Titers Interval 3031.2 to 6996.4	529.9 Titers Interval 352.4 to 796.9

SECONDARY outcome

Timeframe: At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)

Population: The analysis was performed on the PPS that included all subjects who received at least 1 dose of the study treatment to which they were randomized and had post-vaccination data, minus subjects with protocol deviations that led to exclusion.

The detection and the quantification of total IgG antibodies directed against RSVPreF3 in human serum samples are based on an indirect enzyme-linked immunosorbent assay (ELISA). Anti RSVPreF3 antibody concentration is given in geometric mean concentration (GMC) and is expressed in ELISA Laboratory Units per milliliter (ELU/mL). The assay cut-off is 25 ELU/mL.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations Day 1	6676.7 ELU/mL Interval 4490.0 to 9928.2	7090.2 ELU/mL Interval 5123.8 to 9811.4
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations Day 31	85282.4 ELU/mL Interval 66071.9 to 110078.4	7242.6 ELU/mL Interval 5534.1 to 9478.6
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations Day 61	54076.9 ELU/mL Interval 40417.7 to 72352.2	5625.9 ELU/mL Interval 4322.5 to 7322.3
Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations Day 91	61110.7 ELU/mL Interval 45959.0 to 81257.6	5515.7 ELU/mL Interval 4240.2 to 7174.8

SECONDARY outcome

Timeframe: From Day 1 up to the end of follow-up period (Month 14)

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Any SAEs, up the End of Follow-up Study Period (Month 14)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 up to the end of follow-up period (Month 14)

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

pIMDs are 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 etiology.

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects Reporting pIMDs up to the End of Follow-up Study Period (Month 14)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: During the RSV seasons from Day 1 to Month 14

Population: The analysis was performed on the Exposed Set that included all subjects with at least one study vaccine administration documented.

The number of RTI cases is provided by group. Reported categories are "RSV+ RTI" (= RTI episode tested as RSV positive by quantitative reverse transcription polymerase chain reaction (qRT-PCR) on nasal/throat swab collected at assessment visit) and "RSV- RTI" (= RTI episode tested as RSV negative by qRT-PCR on nasal/throat swab collected at assessment visit).

Outcome measures

Measure	RSV_PreF3_AS01B Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 Participants Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Number of Subjects With Respiratory Tract Infection (RTI) Episodes Reported During RTI Surveillance RSV + RTI	0 Participants	0 Participants
Number of Subjects With Respiratory Tract Infection (RTI) Episodes Reported During RTI Surveillance RSV - RTI	1 Participants	1 Participants

Adverse Events

RSV_PreF3_AS01B Group

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo Group

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	RSV_PreF3_AS01B Group n=20 participants at risk Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 participants at risk Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.

Other adverse events

Measure	RSV_PreF3_AS01B Group n=20 participants at risk Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.	Placebo Group n=20 participants at risk Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.
General disorders Injection site pain	90.0% 18/20 • Number of events 34 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	20.0% 4/20 • Number of events 5 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
General disorders Fatigue	65.0% 13/20 • Number of events 18 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	10.0% 2/20 • Number of events 3 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
General disorders Chills	30.0% 6/20 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
General disorders Pyrexia	25.0% 5/20 • Number of events 6 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
General disorders Injection site swelling	10.0% 2/20 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Musculoskeletal and connective tissue disorders Myalgia	45.0% 9/20 • Number of events 11 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Musculoskeletal and connective tissue disorders Arthralgia	35.0% 7/20 • Number of events 9 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Nervous system disorders Headache	35.0% 7/20 • Number of events 8 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	15.0% 3/20 • Number of events 4 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	10.0% 2/20 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	10.0% 2/20 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Respiratory, thoracic and mediastinal disorders Sneezing	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Gastrointestinal disorders Gastrointestinal disorder	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	10.0% 2/20 • Number of events 2 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Gastrointestinal disorders Constipation	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Gastrointestinal disorders Toothache	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Infections and infestations Nasopharyngitis	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Infections and infestations Rhinitis	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Infections and infestations Tonsillitis	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Investigations Eosinophil count increased	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.
Skin and subcutaneous tissue disorders Erythema	5.0% 1/20 • Number of events 1 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.	0.00% 0/20 • Solicited AEs were collected during the 7-day follow-up period after each vaccination. Unsolicited AEs were collected during the 30-day follow-up period after any vaccination. SAEs were collected during the whole study period, from Day 1 till Month 14.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

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.
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