Trial Outcomes & Findings for A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older (NCT NCT01440387)

Last Updated: 2018-09-07

Results Overview

Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

112 participants

Primary outcome timeframe

At Day 0 and Day 21

Results posted on

2018-09-07

Participant Flow

Participant milestones

Participant milestones
Measure	FLULAVAL QUADRIVALENT Adult Group Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Overall Study STARTED	56	56
Overall Study COMPLETED	56	56
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FLULAVAL QUADRIVALENT Adult Group n=56 Participants Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	Total n=112 Participants Total of all reporting groups
Age, Continuous	40.9 Years STANDARD_DEVIATION 13.33 • n=5 Participants	68.6 Years STANDARD_DEVIATION 4.72 • n=7 Participants	54.75 Years STANDARD_DEVIATION 17.11 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	30 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	26 Participants n=7 Participants	48 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 0 and Day 21

Population: The analyses were performed on According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.

Outcome measures

Outcome measures
Measure	FLULAVAL QUADRIVALENT Adult Group n=56 Participants Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains. Yamagata strain, Day 0	130.4 Titers Interval 92.8 to 183.2	57.3 Titers Interval 44.3 to 74.0
Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains. Yamagata strain, Day 21	404.8 Titers Interval 323.1 to 507.2	355.5 Titers Interval 263.5 to 479.5
Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains. Victoria strain, Day 0	92.8 Titers Interval 66.5 to 129.4	38.5 Titers Interval 28.3 to 52.4
Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains. Victoria strain, Day 21	318.0 Titers Interval 251.4 to 402.3	237.8 Titers Interval 179.7 to 314.9
Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains. H1N1 strain, Day 0	82.0 Titers Interval 54.9 to 122.5	25.0 Titers Interval 17.3 to 36.0
Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains. H1N1 strain, Day 21	392.5 Titers Interval 305.4 to 504.4	223.5 Titers Interval 157.0 to 318.1
Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains. H3N2 strain, Day 0	45.3 Titers Interval 31.3 to 65.4	23.2 Titers Interval 16.4 to 32.8
Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains. H3N2 strain, Day 21	215.4 Titers Interval 166.3 to 278.9	160.1 Titers Interval 115.7 to 221.4

PRIMARY outcome

Timeframe: At Day 0 and Day 21

A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.

Outcome measures

Outcome measures
Measure	FLULAVAL QUADRIVALENT Adult Group n=56 Participants Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Yamagata strain, Day 0	48 Subjects	45 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Yamagata strain, Day 21	56 Subjects	56 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Victoria strain, Day 0	47 Subjects	31 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Victoria strain, Day 21	56 Subjects	55 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. H1N1 strain, Day 0	44 Subjects	26 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. H1N1 strain, Day 21	55 Subjects	52 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. H3N2 strain, Day 0	34 Subjects	28 Subjects
Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. H3N2 strain, Day 21	54 Subjects	53 Subjects

PRIMARY outcome

Timeframe: At Day 21

A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.

Outcome measures

Outcome measures
Measure	FLULAVAL QUADRIVALENT Adult Group n=56 Participants Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Yamagata strain	20 Subjects	35 Subjects
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Victoria strain	19 Subjects	33 Subjects
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. H1N1 strain	28 Subjects	34 Subjects
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. H3N2 strain	27 Subjects	35 Subjects

PRIMARY outcome

Timeframe: At Day 21

SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.

Outcome measures

Outcome measures
Measure	FLULAVAL QUADRIVALENT Adult Group n=56 Participants Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains. Yamagata strain	3.1 Fold increase Interval 2.4 to 4.0	6.2 Fold increase Interval 4.6 to 8.4
HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains. Victoria strain	3.4 Fold increase Interval 2.5 to 4.6	6.2 Fold increase Interval 4.3 to 8.8
HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains. H1N1 strain	4.8 Fold increase Interval 3.3 to 7.0	8.9 Fold increase Interval 5.8 to 13.7
HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains. H3N2 strain	4.8 Fold increase Interval 3.5 to 6.6	6.9 Fold increase Interval 4.7 to 10.1

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling greater than 100 millimeters (mm). i.e. \>100mm.

Outcome measures

Outcome measures
Measure	FLULAVAL QUADRIVALENT Adult Group n=56 Participants Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Redness	1 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Redness	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Pain	41 Subjects	19 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Pain	0 Subjects	0 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Any Swelling	1 Subjects	2 Subjects
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Grade 3 Swelling	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

Solicited general symptoms assessed were chest tightness, chills, cough, fatigue, headache, joint pain at other location, muscle pain, red eyes, sore throat, swelling of the face and fever \[oral temperature ≥ 38.0 degrees Celsius (°C)\]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = oral temperature above 39.0°C

Outcome measures

Outcome measures
Measure	FLULAVAL QUADRIVALENT Adult Group n=56 Participants Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Cough	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Cough	3 Subjects	4 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Joint pain at other location	7 Subjects	3 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Sore throat	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fever	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Chest tightness	0 Subjects	2 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Chest tightness	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Chest tightness	0 Subjects	2 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Chills	1 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Chills	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Chills	1 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Cough	3 Subjects	4 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fatigue	10 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fatigue	0 Subjects	1 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Fatigue	10 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Headache	11 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Headache	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Headache	11 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Joint pain at other location	7 Subjects	3 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Joint pain at other location	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Muscle pain	21 Subjects	6 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Muscle pain	0 Subjects	1 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Muscle pain	21 Subjects	6 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Red eyes	3 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Red eyes	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Red eyes	3 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Sore throat	7 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Sore throat	7 Subjects	5 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Swelling of the face	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Swelling of the face	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Related Swelling of the face	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Any Fever	0 Subjects	0 Subjects
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Grade 3 Fever	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: During the 21-day (Days 0-20) post-vaccination period.

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

An unsolicited AE was defined as any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	FLULAVAL QUADRIVALENT Adult Group n=56 Participants Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).	13 Subjects	12 Subjects

SECONDARY outcome

Timeframe: During the entire study period (Day 0 - Day 20 after vaccination).

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.

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

Outcome measures

Outcome measures
Measure	FLULAVAL QUADRIVALENT Adult Group n=56 Participants Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group n=56 Participants Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)	0 Subjects	0 Subjects

Adverse Events

FLULAVAL QUADRIVALENT Adult Group

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

FLULAVAL QUADRIVALENT Elderly Group

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FLULAVAL QUADRIVALENT Adult Group n=56 participants at risk Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.	FLULAVAL QUADRIVALENT Elderly Group n=56 participants at risk Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
General disorders Pain	73.2% 41/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	33.9% 19/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Chills	1.8% 1/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	8.9% 5/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Cough	5.4% 3/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	7.1% 4/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Fatigue	17.9% 10/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	8.9% 5/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Headache	19.6% 11/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	8.9% 5/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Joint pain at other location	12.5% 7/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	5.4% 3/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Muscle pain	37.5% 21/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	10.7% 6/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Red eyes	5.4% 3/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	0.00% 0/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
General disorders Sore throat	12.5% 7/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	8.9% 5/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.
Infections and infestations Upper respiratory tract infection	10.7% 6/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.	5.4% 3/56 • Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period. For the systematically and non-systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.

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