Trial Outcomes & Findings for Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older (NCT NCT02052596)

NCT ID: NCT02052596

Last Updated: 2018-04-24

Results Overview

This outcome was required only for the GSK1437173A Group. Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

935 participants

Primary outcome timeframe

At 1 month post-Dose 2 (Month 3)

Results posted on

2018-04-24

Participant Flow

Not all subjects who were enrolled started the study due to elimination from statistical analyses or no vaccination received.

For one subject, the reason for withdrawal was incorrectly entered into the eCRF as "lost due to Crohn's disease." The subject withdrew from the study due to a combination of irritable bowel syndrome and time constraints associated with employment. This information was clarified after database freeze.

Participant milestones

Participant milestones
Measure	GSK1437173A Group Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Active Phase STARTED	412	418
Active Phase COMPLETED	396	398
Active Phase NOT COMPLETED	16	20
Safety Phase STARTED	412	418
Safety Phase COMPLETED	385	383
Safety Phase NOT COMPLETED	27	35

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK1437173A Group Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Active Phase Adverse Event	3	2
Active Phase Lost to Follow-up	8	11
Active Phase Protocol Violation	1	2
Active Phase Withdrawal by Subject	3	4
Active Phase Enrolled in error	1	0
Active Phase Lost due to Crohn's disease	0	1
Safety Phase Adverse Event	6	3
Safety Phase Lost to Follow-up	11	18
Safety Phase Protocol Violation	1	2
Safety Phase Withdrawal by Subject	8	11
Safety Phase Enrolled in error	1	0
Safety Phase Lost due to Crohn's disease	0	1

Baseline Characteristics

Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK1437173A Group n=412 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=418 Participants Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.	Total n=830 Participants Total of all reporting groups
Age, Continuous	63.4 Years STANDARD_DEVIATION 8.4 • n=5 Participants	63.1 Years STANDARD_DEVIATION 9.0 • n=7 Participants	63.25 Years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	222 Participants n=5 Participants	225 Participants n=7 Participants	447 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants	193 Participants n=7 Participants	383 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · African Heritage/African American	41 Participants n=5 Participants	53 Participants n=7 Participants	94 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · American Indian or Alaskan Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Central/South Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Asian - Japanese Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Arabic/North African Heritage	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · White - Caucasian/European Heritage	364 Participants n=5 Participants	357 Participants n=7 Participants	721 Participants n=5 Participants
Race/Ethnicity, Customized Geographic ancestry · Mixed Origin	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 month post-Dose 2 (Month 3)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included subjects meeting all eligibility criteria for whom data concerning immunogenicity endpoint measures were available, only for subjects in the GSK1437173A Group.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=369 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group	361 Participants	—

PRIMARY outcome

Timeframe: At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)

Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=369 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=380 Participants Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Antibody Concentrations Against Glycoprotein E (Anti-gE)	51687.7 mIU/mL Interval 48425.1 to 55170.1	57998.6 mIU/mL Interval 54456.9 to 61770.6

PRIMARY outcome

Timeframe: At 1 month post-Dose 1 (Month 1)

Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=374 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=394 Participants Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens Anti-PT	41.1 IU/mL Interval 36.2 to 46.7	53.9 IU/mL Interval 47.4 to 61.4
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens Anti-FHA	309.3 IU/mL Interval 276.4 to 346.0	399.4 IU/mL Interval 359.1 to 444.3
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens Anti-PRN	222.6 IU/mL Interval 186.3 to 266.0	278.1 IU/mL Interval 232.9 to 332.0

PRIMARY outcome

Timeframe: At 1 month post-Dose 1 (Month 1)

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=374 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=394 Participants Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens Anti-D	2.2 IU/mL Interval 1.9 to 2.6	2.5 IU/mL Interval 2.1 to 3.0
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens Anti-T	8.7 IU/mL Interval 7.8 to 9.7	10.1 IU/mL Interval 9.0 to 11.4

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 subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=407 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=412 Participants Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Pain, Dose 1	26 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Redness, Dose 1	119 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Redness, Dose 1	1 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Redness, Dose 3	0 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Pain, Dose 1	315 Participants	156 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Swelling, Dose 1	79 Participants	22 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Swelling, Dose 1	1 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Pain, Dose 2	289 Participants	299 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Pain, Dose 2	15 Participants	21 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Redness, Dose 2	116 Participants	102 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Redness, Dose 2	5 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Swelling, Dose 2	83 Participants	67 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Swelling, Dose 2	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Pain, Dose 3	0 Participants	282 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Pain, Dose 3	0 Participants	24 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Redness, Dose 3	0 Participants	101 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Swelling, Dose 3	0 Participants	76 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Swelling, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Pain, Across doses	346 Participants	357 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Pain, Across doses	39 Participants	39 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Redness, Across doses	167 Participants	148 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Redness, Across doses	6 Participants	7 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Any Swelling, Across doses	124 Participants	115 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose Grade 3 Swelling, Across doses	2 Participants	1 Participants

SECONDARY outcome

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

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). "0" implies that: 1. No data were applicable for the GSK1437173A vaccine at Dose 1 for the Control Group, as it was only administered at Doses 2 and 3 in this group 2. No data were applicable for the Boostrix vaccine at Doses 2 and 3 for any of the groups, as it was only administered at Dose 1 for both the groups. 3\. No data were applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=407 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=409 Participants Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Swelling, GSK1437173A vaccine, Dose 1	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Redness, Boostrix vaccine, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Pain, Boostrix vaccine, Dose 1	183 Participants	156 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Pain, Boostrix vaccine, Dose 1	8 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Pain, GSK1437173A vaccine, Dose 1	290 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Pain, GSK1437173A vaccine, Dose 1	20 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Redness, Boostrix vaccine, Dose 1	31 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Redness, Boostrix vaccine, Dose 1	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Redness, GSK1437173A vaccine, Dose 1	108 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Redness, GSK1437173A vaccine, Dose 1	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Swelling, Boostrix vaccine, Dose 1	23 Participants	22 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Swelling, Boostrix vaccine, Dose 1	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Swelling, GSK1437173A vaccine, Dose 1	67 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Pain, Boostrix vaccine, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Pain, Boostrix vaccine, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Pain, GSK1437173A vaccine, Dose 2	289 Participants	299 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Pain, GSK1437173A vaccine, Dose 2	15 Participants	21 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Redness, Boostrix vaccine, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Redness, Boostrix vaccine, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Redness, GSK1437173A vaccine, Dose 2	116 Participants	102 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Redness, GSK1437173A vaccine, Dose 2	5 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Swelling, Boostrix vaccine, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Swelling, Boostrix vaccine, Dose 2	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Swelling, GSK1437173A vaccine, Dose 2	83 Participants	67 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Swelling, GSK1437173A vaccine, Dose 2	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Pain, Boostrix vaccine, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Pain, Boostrix vaccine, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Pain, GSK1437173A vaccine, Dose 3	0 Participants	282 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Pain, GSK1437173A vaccine, Dose 3	0 Participants	24 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Redness, Boostrix vaccine, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Redness, GSK1437173A vaccine, Dose 3	0 Participants	101 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Redness, GSK1437173A vaccine, Dose 3	0 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Swelling, Boostrix vaccine, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Swelling, Boostrix vaccine, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Swelling, GSK1437173A vaccine, Dose 3	0 Participants	76 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Swelling, GSK1437173A vaccine, Dose 3	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Pain, Boostrix vaccine, Across doses	183 Participants	156 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Pain, Boostrix vaccine, Across doses	8 Participants	3 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Pain, GSK1437173A vaccine, Across doses	339 Participants	344 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Pain, GSK1437173A vaccine, Across doses	34 Participants	37 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Redness, Boostrix vaccine, Across doses	31 Participants	18 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Redness, Boostrix vaccine, Across doses	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Redness, GSK1437173A vaccine, Across doses	163 Participants	144 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Redness, GSK1437173A vaccine, Across doses	6 Participants	6 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Swelling, Boostrix vaccine, Across doses	23 Participants	22 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Swelling, Boostrix vaccine, Across doses	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Any Swelling, GSK1437173A vaccine, Across doses	117 Participants	109 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine Grade 3 Swelling, GSK1437173A vaccine,Across doses	2 Participants	0 Participants

SECONDARY outcome

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

Population: The analisys was performed on the Total vaccinated cohort, which included all subjects with at least one vaccine administration documented, on subjects with their symptom sheets completed.

Assessed solicited general symptoms were fatigue, gastrointestinal (symptoms included nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as oral, axillary, rectal or tympanic temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = temperature above (\>) 39.0 °C. Related = general symptom assessed by the investigator as causally related to vaccination. "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=407 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=412 Participants Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Myalgia, Dose 1	12 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Shivering, Dose 1	6 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Myalgia, Dose 2	17 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Shivering, Dose 2	60 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Fatigue, Dose 3	0 Participants	130 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Gastrointestinal, Dose 3	0 Participants	54 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Myalgia, Dose 3	0 Participants	164 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Shivering, Dose 3	0 Participants	11 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Temperature, Dose 3	0 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Myalgia, Across doses	27 Participants	32 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Shivering, Across doses	18 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Temperature, Across doses	72 Participants	63 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Fatigue, Dose 1	129 Participants	65 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Fatigue, Dose 1	12 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Fatigue, Dose 1	88 Participants	37 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Gastrointestinal, Dose 1	52 Participants	35 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Gastrointestinal, Dose 1	2 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Gastrointestinal, Dose 1	25 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Headache, Dose 1	106 Participants	60 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Headache, Dose 1	7 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Headache, Dose 1	74 Participants	32 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Myalgia, Dose 1	177 Participants	102 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Myalgia, Dose 1	134 Participants	76 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Shivering, Dose 1	64 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Shivering, Dose 1	48 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Temperature, Dose 1	36 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Temperature, Dose 1	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Temperature, Dose 1	26 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Fatigue, Dose 2	137 Participants	110 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Fatigue, Dose 2	22 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Fatigue, Dose 2	101 Participants	74 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Gastrointestinal, Dose 2	51 Participants	46 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Gastrointestinal, Dose 2	5 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Gastrointestinal, Dose 2	34 Participants	28 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Headache, Dose 2	99 Participants	82 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Headache, Dose 2	10 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Headache, Dose 2	74 Participants	54 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Myalgia, Dose 2	160 Participants	155 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Myalgia, Dose 2	122 Participants	116 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Shivering, Dose 2	79 Participants	38 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Shivering, Dose 2	12 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Temperature, Dose 2	51 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Temperature, Dose 2	2 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Temperature, Dose 2	32 Participants	16 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Fatigue, Dose 3	0 Participants	14 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Fatigue, Dose 3	0 Participants	92 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Gastrointestinal, Dose 3	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Gastrointestinal, Dose 3	0 Participants	37 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Headache, Dose 3	0 Participants	95 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Headache, Dose 3	0 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Headache, Dose 3	0 Participants	69 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Myalgia, Dose 3	0 Participants	19 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Myalgia, Dose 3	0 Participants	124 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Shivering, Dose 3	0 Participants	65 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Shivering, Dose 3	0 Participants	50 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Temperature, Dose 3	0 Participants	43 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Temperature, Dose 3	0 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Fatigue, Across doses	186 Participants	192 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Fatigue, Across doses	30 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Fatigue, Across doses	143 Participants	134 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Gastrointestinal, Across doses	85 Participants	97 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Gastrointestinal, Across doses	7 Participants	9 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Gastrointestinal, Across doses	51 Participants	62 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Headache, Across doses	152 Participants	158 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Headache, Across doses	16 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Headache, Across doses	118 Participants	108 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Myalgia, Across doses	227 Participants	243 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Myalgia, Across doses	176 Participants	186 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Any Shivering, Across doses	112 Participants	100 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Shivering, Across doses	86 Participants	72 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Grade 3 Temperature, Across doses	3 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose Related Temperature, Across doses	48 Participants	41 Participants

SECONDARY outcome

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

The number of days with local and general symptoms have been assessed during the solicited post-vaccination period. "0" Implied that no data was applicable for the GSK1437173A Group at Dose 3, since it received only 2 vaccine doses

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=315 Doses with the symptom Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=299 Doses with the symptom Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Number of Days With Solicited Symptoms Pain, Dose 2	2.8 Days Interval 2.0 to 4.0	2.9 Days Interval 2.0 to 4.0
Number of Days With Solicited Symptoms Shivering, Dose 3	—	1.5 Days Interval 1.0 to 1.0
Number of Days With Solicited Symptoms Temperature, Dose 1	1.7 Days Interval 1.0 to 2.0	2.4 Days Interval 1.0 to 3.0
Number of Days With Solicited Symptoms Pain, Dose 1	3.2 Days Interval 2.0 to 4.0	2.6 Days Interval 2.0 to 3.0
Number of Days With Solicited Symptoms Pain, Dose 3	—	2.7 Days Interval 2.0 to 3.0
Number of Days With Solicited Symptoms Redness, Dose 1	3.3 Days Interval 2.0 to 5.0	3.0 Days Interval 2.0 to 5.0
Number of Days With Solicited Symptoms Redness, Dose 2	3.2 Days Interval 2.0 to 4.0	3.2 Days Interval 2.0 to 4.0
Number of Days With Solicited Symptoms Redness, Dose 3	—	2.9 Days Interval 2.0 to 4.0
Number of Days With Solicited Symptoms Swelling, Dose 1	3.3 Days Interval 2.0 to 5.0	3.5 Days Interval 2.0 to 5.0
Number of Days With Solicited Symptoms Swelling, Dose 2	3.1 Days Interval 2.0 to 4.0	3.0 Days Interval 2.0 to 4.0
Number of Days With Solicited Symptoms Swelling, Dose 3	—	2.9 Days Interval 2.0 to 4.0
Number of Days With Solicited Symptoms Fatigue, Dose 1	2.4 Days Interval 1.0 to 3.0	2.5 Days Interval 1.0 to 4.0
Number of Days With Solicited Symptoms Fatigue, Dose 2	2.3 Days Interval 1.0 to 3.0	2.7 Days Interval 1.0 to 3.0
Number of Days With Solicited Symptoms Fatigue, Dose 3	—	2.6 Days Interval 1.0 to 4.0
Number of Days With Solicited Symptoms Gastrointestinal, Dose 1	2.3 Days Interval 1.0 to 4.0	2.1 Days Interval 1.0 to 3.0
Number of Days With Solicited Symptoms Gastrointestinal, Dose 2	2.0 Days Interval 1.0 to 2.0	2.3 Days Interval 1.0 to 3.0
Number of Days With Solicited Symptoms Gastrointestinal, Dose 3	—	1.9 Days Interval 1.0 to 3.0
Number of Days With Solicited Symptoms Headache, Dose 1	1.8 Days Interval 1.0 to 2.0	2.2 Days Interval 1.0 to 2.0
Number of Days With Solicited Symptoms Headache, Dose 2	1.9 Days Interval 1.0 to 2.0	2.1 Days Interval 1.0 to 3.0
Number of Days With Solicited Symptoms Headache, Dose 3	—	2.0 Days Interval 1.0 to 2.0
Number of Days With Solicited Symptoms Myalgia, Dose 1	2.9 Days Interval 2.0 to 4.0	2.3 Days Interval 1.0 to 3.0
Number of Days With Solicited Symptoms Myalgia, Dose 2	2.7 Days Interval 2.0 to 3.5	2.9 Days Interval 1.0 to 4.0
Number of Days With Solicited Symptoms Myalgia, Dose 3	—	2.7 Days Interval 1.0 to 3.0
Number of Days With Solicited Symptoms Shivering, Dose 1	1.6 Days Interval 1.0 to 2.0	2.3 Days Interval 1.0 to 3.0
Number of Days With Solicited Symptoms Shivering, Dose 2	1.6 Days Interval 1.0 to 2.0	1.6 Days Interval 1.0 to 2.0
Number of Days With Solicited Symptoms Temperature, Dose 2	1.6 Days Interval 1.0 to 2.0	1.5 Days Interval 1.0 to 1.0
Number of Days With Solicited Symptoms Temperature, Dose 3	—	1.5 Days Interval 1.0 to 2.0

SECONDARY outcome

Timeframe: From first vaccination up to study end (Day 0 to Month 14)

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

Potential immune-mediated diseases (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 aetiology. Related = pIMDs assessed by the investigator as causally related to the study vaccination.

Outcome measures

Outcome measures
Measure	GSK1437173A Group n=412 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=418 Participants Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Related pIMD(s)	0 Participants	0 Participants
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) Any pIMD(s)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within the 30-day (Days 0-29) post-vaccination period

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

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

Outcome measures
Measure	GSK1437173A Group n=412 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=418 Participants Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	105 Participants	118 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	10 Participants	15 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	27 Participants	31 Participants

SECONDARY outcome

Timeframe: From first vaccination up to study end (Day 0 to Month 14)

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

Serious adverse events (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

Outcome measures
Measure	GSK1437173A Group n=412 Participants Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=418 Participants Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
Number of Subjects With Any Serious Adverse Events (SAEs)	21 Participants	31 Participants

Adverse Events

GSK1437173A Group

Serious events: 21 serious events

Other events: 368 other events

Deaths: 4 deaths

Control Group

Serious events: 31 serious events

Other events: 380 other events

Deaths: 5 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	GSK1437173A Group n=412 participants at risk Subjects received one injection of Boostrix vaccine and one injection of the GSK1437173A vaccine during the first visit and a second injection of the GSK1437173A vaccine during the third visit, two months later.	Control Group n=418 participants at risk Subjects received all vaccines separately i.e. one injection of Boostrix vaccine at the first visit, one injection of the GSK1437173A vaccine at the third visit and a second injection of the GSK1437173A vaccine at the fourth visit, all two months apart.
General disorders Chills	27.2% 112/412 • Number of events 144 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.	24.4% 102/418 • Number of events 121 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.
Skin and subcutaneous tissue disorders Erythema	40.5% 167/412 • Number of events 235 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.	35.4% 148/418 • Number of events 222 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.
General disorders Fatigue	45.1% 186/412 • Number of events 267 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.	45.9% 192/418 • Number of events 306 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.
Gastrointestinal disorders Gastrointestinal disorder	20.6% 85/412 • Number of events 103 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.	23.2% 97/418 • Number of events 135 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.
Nervous system disorders Headache	37.1% 153/412 • Number of events 207 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.	38.0% 159/418 • Number of events 242 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.
Musculoskeletal and connective tissue disorders Myalgia	55.3% 228/412 • Number of events 341 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.	58.1% 243/418 • Number of events 423 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.
General disorders Pain	84.0% 346/412 • Number of events 605 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.	85.4% 357/418 • Number of events 740 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.
General disorders Pyrexia	18.0% 74/412 • Number of events 89 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.	15.3% 64/418 • Number of events 76 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.
General disorders Swelling	30.1% 124/412 • Number of events 162 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.	27.5% 115/418 • Number of events 165 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 30-day (Days 0-29) post-vaccination period; SAEs: from first vaccination up to study end at Month 14.

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