Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older (NCT NCT03439657)

NCT ID: NCT03439657

Last Updated: 2022-01-11

Results Overview

Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 913 participants
• Primary outcome timeframe: One month post-dose 2 (Month 3)
• Results posted on: 2022-01-11

Participant Flow

The study was conducted in 4 countries (Canada, Estonia, Germany & United States)

Out of 913 subjects enrolled in the study, 1 subject violated protocol prior to randomization. 912 subjects were vaccinated and included in the Exposed Set, 901 subjects completed the study.

Participant milestones

Measure	Co-Ad Group Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Overall Study STARTED	449	463
Overall Study COMPLETED	442	459
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Measure	Co-Ad Group Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Overall Study Adverse Event	2	3
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	1	1
Overall Study Consent withdrawal, not due to an Adverse Event	3	0

Baseline Characteristics

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older

Baseline characteristics by cohort

Measure	Co-Ad Group n=449 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Total n=912 Participants Total of all reporting groups
Age, Continuous	63.1 Years STANDARD_DEVIATION 8.3 • n=5 Participants	63.2 Years STANDARD_DEVIATION 8.4 • n=7 Participants	63.1 Years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	259 Participants n=5 Participants	284 Participants n=7 Participants	543 Participants n=5 Participants
Sex: Female, Male Male	190 Participants n=5 Participants	179 Participants n=7 Participants	369 Participants n=5 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Origin	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian / European Heritage	439 Participants n=5 Participants	452 Participants n=7 Participants	891 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month post-dose 2 (Month 3)

Population: Analysis was performed on the Per-Protocol Set (PPS) for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.

Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline.

Outcome measures

Measure	Co-Ad Group n=426 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group	99.1 Percentage of subjects Interval 97.6 to 99.7	—

PRIMARY outcome

Timeframe: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).

Population: Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.

Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL)

Outcome measures

Measure	Co-Ad Group n=426 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=436 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Anti-gE Antibody Concentrations	54789.9 mlU/mL Interval 51586.3 to 58192.4	59126.7 mlU/mL Interval 55973.8 to 62457.1

PRIMARY outcome

Timeframe: At one month post-dose 1 (Month 1)

Population: Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.

Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA)

Outcome measures

Measure	Co-Ad Group n=425 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=434 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Anti-pneumococcal Antibody Titers MOPA-1	144.2 Titers Interval 120.5 to 172.6	151.5 Titers Interval 126.0 to 182.1
Anti-pneumococcal Antibody Titers MOPA-3	99.8 Titers Interval 87.2 to 114.1	100.2 Titers Interval 88.0 to 114.1
Anti-pneumococcal Antibody Titers MOPA-4	1127.2 Titers Interval 975.5 to 1302.5	1392.4 Titers Interval 1206.5 to 1607.0
Anti-pneumococcal Antibody Titers MOPA-5	279.4 Titers Interval 231.2 to 337.7	292.8 Titers Interval 243.5 to 352.1
Anti-pneumococcal Antibody Titers MOPA-6A	1839.3 Titers Interval 1570.0 to 2154.9	2354.9 Titers Interval 2015.0 to 2752.2
Anti-pneumococcal Antibody Titers MOPA-6B	1499.4 Titers Interval 1241.2 to 1811.4	2025.9 Titers Interval 1715.5 to 2392.4
Anti-pneumococcal Antibody Titers MOPA-7F	1981 Titers Interval 1735.2 to 2261.5	2387.5 Titers Interval 2112.7 to 2698.0
Anti-pneumococcal Antibody Titers MOPA-9V	2541.9 Titers Interval 2219.2 to 2911.7	3049.3 Titers Interval 2693.7 to 3451.9
Anti-pneumococcal Antibody Titers MOPA-14	1752.6 Titers Interval 1505.2 to 2040.6	2096 Titers Interval 1796.6 to 2445.2
Anti-pneumococcal Antibody Titers MOPA-18C	1450.3 Titers Interval 1262.5 to 1666.1	1606.6 Titers Interval 1402.6 to 1840.4
Anti-pneumococcal Antibody Titers MOPA-19A	1684.9 Titers Interval 1477.2 to 1921.9	1664.3 Titers Interval 1465.7 to 1889.7
Anti-pneumococcal Antibody Titers MOPA-19F	712 Titers Interval 617.1 to 821.6	802.4 Titers Interval 696.2 to 924.8
Anti-pneumococcal Antibody Titers MOPA-23F	758.1 Titers Interval 644.9 to 891.2	925.5 Titers Interval 782.5 to 1094.7

PRIMARY outcome

Timeframe: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).

Population: Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.

Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL)

Outcome measures

Measure	Co-Ad Group n=435 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=426 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody	58526.8 mlU/mL Interval 55248.5 to 61999.7	54634.9 mlU/mL Interval 51546.0 to 57909.0

PRIMARY outcome

Timeframe: At one month post-dose 1 (Month 1)

Population: Analysis was performed on the PPS for immunogenicity that included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis and for whom data concerning immunogenicity outcome measures were available.

Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model.

Outcome measures

Measure	Co-Ad Group n=433 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=425 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-1	147.1 Titers Interval 123.9 to 174.7	141.2 Titers Interval 118.7 to 167.9
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-3	99.6 Titers Interval 88.1 to 112.6	97.3 Titers Interval 86.0 to 110.0
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-4	1331.6 Titers Interval 1155.2 to 1535.0	1066.9 Titers Interval 924.2 to 1231.5
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-5	278.9 Titers Interval 234.4 to 331.8	269.1 Titers Interval 225.8 to 320.8
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-6A	2253.8 Titers Interval 1935.6 to 2624.3	1784.4 Titers Interval 1530.2 to 2080.8
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-6B	1967.3 Titers Interval 1661.5 to 2329.3	1445.4 Titers Interval 1219.3 to 1713.4
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-7F	2337.3 Titers Interval 2061.2 to 2650.5	1935.1 Titers Interval 1704.3 to 2197.1
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-9V	2955.8 Titers Interval 2601.9 to 3357.9	2553.5 Titers Interval 2244.2 to 2905.4
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-14	1992.3 Titers Interval 1718.5 to 2309.7	1730.7 Titers Interval 1491.3 to 2008.5
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-18C	1558.9 Titers Interval 1363.9 to 1781.9	1403.8 Titers Interval 1226.4 to 1606.8
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-19A	1663.5 Titers Interval 1474.0 to 1877.2	1619.2 Titers Interval 1433.7 to 1828.7
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-19F	760.2 Titers Interval 664.8 to 869.2	696.4 Titers Interval 608.2 to 797.3
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies MOPA-23F	896.6 Titers Interval 765.0 to 1050.9	748.2 Titers Interval 637.6 to 878.0

SECONDARY outcome

Timeframe: Within 7 days (Day 1 - 7) after each vaccination

Population: Analysis was performed on Exposed Set (ES) which included all subjects with at least one vaccine administration documented and who provided solicited safety data.

Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.

Outcome measures

Measure	Co-Ad Group n=447 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Erythema, GSK1437173A, Dose1	120 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Erythema, GSK1437173A, Dose1	5 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Erythema, Prevenar13, Dose1	48 Participants	31 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Erythema, Prevenar13, Dose1	2 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Pain, GSK1437173A, Dose1	332 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Pain, GSK1437173A, Dose1	25 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Pain, Prevenar13, Dose1	233 Participants	241 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Pain, Prevenar13, Dose1	11 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Swelling, GSK1437173A, Dose1	69 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Swelling, GSK1437173A, Dose1	0 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Swelling, Prevenar13, Dose1	33 Participants	21 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Swelling, Prevenar13, Dose1	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Erythema, GSK1437173A, Dose2	147 Participants	128 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Erythema, GSK1437173A, Dose2	9 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Pain, GSK1437173A, Dose2	326 Participants	359 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Pain, GSK1437173A, Dose2	28 Participants	32 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Swelling, GSK1437173A, Dose2	70 Participants	72 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Swelling, GSK1437173A, Dose2	1 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Erythema, GSK1437173A, Dose3	0 Participants	123 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Erythema, GSK1437173A, Dose3	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Pain, GSK1437173A, Dose3	0 Participants	350 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Pain, GSK1437173A, Dose3	0 Participants	41 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Any Swelling, GSK1437173A, Dose3	0 Participants	60 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose Grade3 Swelling, GSK1437173A, Dose3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 7 days (Day 1 - 7) after each vaccination

Population: Analysis was performed on ES which included all subjects with at least one vaccine administration documented and who provided solicited safety data and for those who experienced the specified symptom for the specific dose.

The number of days with any local symptoms had been assessed during the post-vaccination period.

Outcome measures

Measure	Co-Ad Group n=347 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=359 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Number of Days With Each Solicited Local Symptoms Any erythema,Dose1	3 Days Interval 2.0 to 5.0	2 Days Interval 1.0 to 4.0
Number of Days With Each Solicited Local Symptoms Any pain,Dose1	3 Days Interval 2.0 to 4.0	2 Days Interval 1.0 to 2.0
Number of Days With Each Solicited Local Symptoms Any swelling, Dose1	2 Days Interval 2.0 to 4.0	2 Days Interval 1.0 to 3.0
Number of Days With Each Solicited Local Symptoms Any erythema, Dose2	3 Days Interval 2.0 to 4.0	2 Days Interval 2.0 to 4.0
Number of Days With Each Solicited Local Symptoms Any pain,Dose2	3 Days Interval 2.0 to 4.0	3 Days Interval 2.0 to 4.0
Number of Days With Each Solicited Local Symptoms Any swelling, Dose2	3 Days Interval 2.0 to 4.0	2 Days Interval 1.5 to 4.0
Number of Days With Each Solicited Local Symptoms Any erythema,Dose3	—	2 Days Interval 2.0 to 3.0
Number of Days With Each Solicited Local Symptoms Any pain,Dose3	—	3 Days Interval 2.0 to 3.0
Number of Days With Each Solicited Local Symptoms Any swelling,Dose3	—	2 Days Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: Within 7 days (Day 1 - 7) after each vaccination

Population: Analysis was performed on ES which included all subjects with at least one vaccine administration documented and who provided solicited safety data.

Assessed solicited general symptoms were fatigue, fever [defined as oral temperature ≥ 38.0 degrees Celsius (°C)/ 100.4 degrees Fahrenheit (°F)], GastroIntestinal (GI) symptoms, headache, myalgia and shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Outcome measures

Measure	Co-Ad Group n=448 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose1	166 Participants	85 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Fatigue, Dose1	21 Participants	5 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose1	149 Participants	67 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose1	10 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Fever, Dose1	1 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose1	8 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any GI symptoms, Dose1	61 Participants	37 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 GI symptoms, Dose1	6 Participants	1 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related GI symptoms, Dose1	55 Participants	30 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose1	130 Participants	72 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Headache, Dose1	10 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose1	113 Participants	59 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose1	168 Participants	102 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Myalgia, Dose1	17 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose1	150 Participants	86 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose1	78 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Shivering, Dose1	9 Participants	0 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose1	71 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose2	192 Participants	152 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Fatigue, Dose2	22 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose2	177 Participants	141 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose2	16 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Fever, Dose2	2 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose2	10 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any GI symptoms, Dose2	57 Participants	47 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 GI symptoms, Dose2	8 Participants	4 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related GI symptoms, Dose2	50 Participants	44 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose2	156 Participants	115 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Headache, Dose2	18 Participants	7 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose2	143 Participants	99 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose2	203 Participants	174 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Myalgia, Dose2	23 Participants	24 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose2	186 Participants	163 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose2	95 Participants	50 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Shivering, Dose2	12 Participants	8 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose2	86 Participants	47 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fatigue, Dose3	0 Participants	210 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Fatigue, Dose3	0 Participants	27 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fatigue, Dose3	0 Participants	202 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Fever, Dose3	0 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Fever, Dose3	0 Participants	2 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Fever, Dose3	0 Participants	17 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any GI symptoms, Dose3	0 Participants	69 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 GI symptoms, Dose3	0 Participants	3 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related GI symptoms, Dose3	0 Participants	63 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Headache, Dose3	0 Participants	180 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Headache, Dose3	0 Participants	23 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Headache, Dose3	0 Participants	168 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Myalgia, Dose3	0 Participants	224 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Myalgia, Dose3	0 Participants	37 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Myalgia, Dose3	0 Participants	215 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Shivering, Dose3	0 Participants	122 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade3 Shivering, Dose3	0 Participants	20 Participants
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Shivering, Dose3	0 Participants	117 Participants

SECONDARY outcome

Timeframe: Within 7 days (Day 1 - 7) after each vaccination

Population: Analysis was performed on ES which included all subjects with at least one vaccine administration documented and who provided solicited safety data and for those who experienced the specified symptom for the specific dose.

The number of days with any general symptoms had been assessed during the post-vaccination period. Assessed solicited general symptoms were fatigue, fever, GastroIntestinal (GI) symptoms, headache, myalgia and shivering.

Outcome measures

Measure	Co-Ad Group n=203 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=224 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Number of Days With Solicited General Symptoms Any fatigue,Dose1	2 Days Interval 1.0 to 3.0	2 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any GI symptoms,Dose1	2 Days Interval 1.0 to 2.0	1 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any headache,Dose1	2 Days Interval 1.0 to 3.0	1 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any myalgia,Dose1	2 Days Interval 1.0 to 3.0	2 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any shivering,Dose1	1 Days Interval 1.0 to 2.0	1 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any fever,Dose1	1 Days Interval 1.0 to 1.0	1 Days Interval 1.0 to 1.0
Number of Days With Solicited General Symptoms Any fatigue,Dose2	2 Days Interval 1.0 to 3.0	2 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any GI symptoms,Dose2	1 Days Interval 1.0 to 2.0	1 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any headache,Dose2	2 Days Interval 1.0 to 3.0	2 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any myalgia,Dose2	2 Days Interval 1.0 to 3.0	2 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any shivering,Dose2	1 Days Interval 1.0 to 2.0	1 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any fever,Dose2	1 Days Interval 1.0 to 1.0	1 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any fatigue,Dose3	—	2 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any GI symptoms,Dose3	—	1 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any headache,Dose3	—	1.5 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any myalgia,Dose3	—	2 Days Interval 1.0 to 3.0
Number of Days With Solicited General Symptoms Any shivering,Dose3	—	1 Days Interval 1.0 to 2.0
Number of Days With Solicited General Symptoms Any fever,Dose3	—	1 Days Interval 1.0 to 1.0

SECONDARY outcome

Timeframe: Within 30 days (Day 1 to 30) after each vaccination

Population: Analysis was performed on ES which included all subjects with at least one vaccine administered.

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

Outcome measures

Measure	Co-Ad Group n=449 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE) Subjects with any AEs	95 Participants	107 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE) Subjects with Grade 3 AEs	9 Participants	13 Participants
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE) Subjects with related AEs	35 Participants	25 Participants

SECONDARY outcome

Timeframe: From first vaccination at Day 1 up to 30 days post last vaccination

Population: Analysis was performed on ES which included all subjects with at least one vaccine administered.

SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	Co-Ad Group n=449 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination Subjects with any SAEs	7 Participants	8 Participants
Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination Subjects with related SAEs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)

Population: Analysis was performed on ES which included all subjects with at least one vaccine administered.

Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	Co-Ad Group n=449 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End. Subjects with any SAEs	10 Participants	10 Participants
Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End. Subjects with related SAEs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From first vaccination at Day 1 up to 30 days post last vaccination.

Population: Analysis was performed on ES which included all subjects with at least one vaccine administered.

pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as causally related to the study vaccination.

Outcome measures

Measure	Co-Ad Group n=449 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination Subjects with any pIMDs	1 Participants	1 Participants
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination Subjects with related pIMDs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)

Population: Analysis was performed on ES which included all subjects with at least one vaccine administered.

pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology.

Outcome measures

Measure	Co-Ad Group n=449 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End.	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Within 7 days (Day 1 - 7) after each vaccination

Population: Analysis was performed on Exposed Set (ES) which included all subjects with at least one vaccine administration documented and who provided solicited safety data.

Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.

Outcome measures

Measure	Co-Ad Group n=448 Participants Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 Participants Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Any Erythema, Dose1	131 Participants	31 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Grade3 Erythema, Dose1	7 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Any Pain, Dose1	347 Participants	241 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Grade3 Pain, Dose1	28 Participants	9 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Any Swelling, Dose1	76 Participants	21 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Grade3 Swelling, Dose1	1 Participants	0 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Any Erythema, Dose2	147 Participants	128 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Grade3 Erythema, Dose2	9 Participants	5 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Any Pain, Dose2	326 Participants	359 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Grade3 Pain, Dose2	28 Participants	32 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Any Swelling, Dose2	70 Participants	72 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Grade3 Swelling, Dose2	1 Participants	2 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Any Erythema, Dose3	0 Participants	123 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Grade3 Erythema, Dose3	0 Participants	1 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Any Pain, Dose3	0 Participants	350 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Grade3 Pain, Dose3	0 Participants	41 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Any Swelling, Dose3	0 Participants	60 Participants
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose Grade3 Swelling, Dose3	0 Participants	0 Participants

Adverse Events

Co-Ad Group

Serious events: 16 serious events

Other events: 419 other events

Deaths: 2 deaths

Control Group

Serious events: 16 serious events

Other events: 427 other events

Deaths: 4 deaths

Serious adverse events

Measure	Co-Ad Group n=449 participants at risk Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 participants at risk Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Cardiac disorders Acute myocardial infarction	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Angina pectoris	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Angina unstable	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Atrial fibrillation	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Cardiac failure chronic	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Coronary artery disease	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Dressler's syndrome	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Hypertensive heart disease	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Myocardial infarction	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Pericardial effusion	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Pericarditis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Stress cardiomyopathy	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Ventricular fibrillation	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Congenital, familial and genetic disorders Hypertrophic cardiomyopathy	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Gastrooesophageal reflux disease	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Inguinal hernia	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Oesophagitis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Volvulus	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Multiple organ dysfunction syndrome	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Hepatobiliary disorders Cholelithiasis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Appendicitis	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Diverticulitis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Escherichia bacteraemia	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Peritonitis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Pneumonia	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Pyelonephritis acute	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Sepsis	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Endometrial adenocarcinoma	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic carcinoma of the bladder	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Monoclonal gammopathy	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Cerebral haematoma	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Cerebrovascular accident	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Renal and urinary disorders Nephrotic syndrome	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Reproductive system and breast disorders Ovarian cyst	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Asthma	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]

Other adverse events

Measure	Co-Ad Group n=449 participants at risk Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm	Control Group n=463 participants at risk Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Nervous system disorders Headache	45.9% 206/449 • Number of events 287 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	52.1% 241/463 • Number of events 376 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Hypoaesthesia	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Neuralgia	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Pain in extremity	0.89% 4/449 • Number of events 5 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.65% 3/463 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Tendon disorder	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Burning sensation	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Carotid artery stenosis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Dizziness	0.67% 3/449 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Dysgeusia	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Blood and lymphatic system disorders Pseudolymphoma	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Cardiac disorders Palpitations	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Ear and labyrinth disorders Presbyacusis	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Ear and labyrinth disorders Vertigo	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Endocrine disorders Autoimmune thyroiditis	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Eye disorders Ocular hyperaemia	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Eye disorders Retinal detachment	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Abdominal pain	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Abdominal pain upper	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Aphthous ulcer	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Constipation	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Dental caries	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Diarrhoea	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Dyspepsia	0.67% 3/449 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Enteritis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Food poisoning	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Gastrointestinal disorder	22.7% 102/449 • Number of events 118 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	25.7% 119/463 • Number of events 153 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Gastrooesophageal reflux disease	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Mouth haemorrhage	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Nausea	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Rectal fissure	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Gastrointestinal disorders Tongue eruption	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Administration site pruritus	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Asthenia	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Axillary pain	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Chest pain	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Chills	31.0% 139/449 • Number of events 174 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	30.9% 143/463 • Number of events 179 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Fatigue	54.1% 243/449 • Number of events 361 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	56.4% 261/463 • Number of events 448 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Feeling hot	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Influenza like illness	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site bruising	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site erythema	42.8% 192/449 • Number of events 278 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	41.0% 190/463 • Number of events 286 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site hypoaesthesia	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site movement impairment	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site oedema	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site pain	86.6% 389/449 • Number of events 673 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	87.7% 406/463 • Number of events 952 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site pruritus	1.6% 7/449 • Number of events 9 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	1.5% 7/463 • Number of events 10 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site rash	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site reaction	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site swelling	24.1% 108/449 • Number of events 146 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	25.3% 117/463 • Number of events 156 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Injection site warmth	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Malaise	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Non-cardiac chest pain	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Oedema peripheral	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Pain	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Peripheral swelling	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Pyrexia	5.1% 23/449 • Number of events 26 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	6.3% 29/463 • Number of events 32 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
General disorders Sensation of foreign body	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Immune system disorders Hypersensitivity	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Immune system disorders Seasonal allergy	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Anal abscess	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Bronchitis	1.1% 5/449 • Number of events 5 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Cystitis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Ear infection	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Erysipelas	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Fungal infection	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Fungal skin infection	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Gastroenteritis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.65% 3/463 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Genital infection fungal	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Herpes simplex	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Impetigo	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Infection	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Influenza	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.65% 3/463 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Injection site cellulitis	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Laryngitis	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Lower respiratory tract infection	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Nasopharyngitis	0.67% 3/449 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	1.5% 7/463 • Number of events 7 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Oral herpes	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Otitis externa	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Otitis media	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Pharyngitis streptococcal	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Pneumonia	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Pulpitis dental	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Rash pustular	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Sinusitis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.86% 4/463 • Number of events 4 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Upper respiratory tract infection	0.89% 4/449 • Number of events 4 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	1.5% 7/463 • Number of events 7 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Urinary tract infection	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Viral upper respiratory tract infection	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.86% 4/463 • Number of events 4 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Injury, poisoning and procedural complications Animal bite	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Injury, poisoning and procedural complications Contusion	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Injury, poisoning and procedural complications Head injury	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Injury, poisoning and procedural complications Limb injury	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Injury, poisoning and procedural complications Mallet finger	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Injury, poisoning and procedural complications Procedural pain	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Metabolism and nutrition disorders Decreased appetite	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Metabolism and nutrition disorders Dyslipidaemia	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 5/449 • Number of events 6 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	1.7% 8/463 • Number of events 10 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Arthritis	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Axillary mass	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Back pain	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Flank pain	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Limb discomfort	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Myalgia	57.9% 260/449 • Number of events 373 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	61.3% 284/463 • Number of events 501 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Neck pain	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Neuromuscular blockade	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Paraesthesia	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Sciatica	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders Trigeminal neuralgia	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Nervous system disorders VIth nerve paresis	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Psychiatric disorders Acute stress disorder	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Psychiatric disorders Depression	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Psychiatric disorders Insomnia	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Psychiatric disorders Restlessness	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Renal and urinary disorders Haematuria	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Renal and urinary disorders Nephrolithiasis	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Renal and urinary disorders Urinary retention	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Reproductive system and breast disorders Breast pain	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Reproductive system and breast disorders Ovarian cyst	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Asthma	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Cough	0.45% 2/449 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Epistaxis	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.22% 1/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Lower respiratory tract congestion	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.67% 3/449 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Respiratory, thoracic and mediastinal disorders Throat irritation	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Acne	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Dermatitis	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Eczema	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Erythema	1.3% 6/449 • Number of events 7 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.86% 4/463 • Number of events 6 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Hyperhidrosis	0.45% 2/449 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Night sweats	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Peau d'orange	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Pruritus	0.45% 2/449 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Rash	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.43% 2/463 • Number of events 2 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Vascular disorders Aortic stenosis	0.22% 1/449 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.00% 0/463 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Vascular disorders Circulatory collapse	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Vascular disorders Hypertension	0.67% 3/449 • Number of events 3 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	1.1% 5/463 • Number of events 5 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]
Vascular disorders Lymphoedema	0.00% 0/449 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]	0.22% 1/463 • Number of events 1 • Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]

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.
• Publication restrictions are in place

Restriction type: OTHER