Immunogenicity and Safety Study of GSK Biologicals' Herpe... | NCT03439657

ID	Type	Description	Link
2017-001220-22	EudraCT Number

Label	Type	Description	Intervention Names
Co-Ad Group	Experimental	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	Biological: HZ/su vaccine GSK1437173A Biological: Prevenar13
Control Group	Active Comparator	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	Biological: HZ/su vaccine GSK1437173A Biological: Prevenar13

Name	Type	Description	Arm Group Labels	Other Names
HZ/su vaccine GSK1437173A	Biological	2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.

Measure	Description	Time Frame
Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group	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.	One month post-dose 2 (Month 3)
Anti-gE Antibody Concentrations	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)	One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Anti-pneumococcal Antibody Titers	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)	At one month post-dose 1 (Month 1)
Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody	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)	One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies	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.

Measure	Description	Time Frame
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the subject prior to performance of any study specific procedure.
A male or female, aged ≥50 YOA at the time of the first vaccination with the study vaccine(s).
Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -30 to Day 1), or planned use during the study period.
Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
Use or anticipated use of immunosuppressants or other immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (>14 consecutive days of prednisone at a dose of ≥20 mg/day [or equivalent]), long-acting immune modifying agents or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular corticosteroids are allowed.
Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
Previous and/or planned administration of an HZ or VZV vaccine other than the study vaccine during the study period.
History of HZ.
History of documented pneumococcal infection within 5 previous years.
Prior receipt of any pneumococcal vaccine or planned use during the study period, other than the study vaccines.
Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Acute disease and/or fever at the time of enrollment.
- Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
- Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions before 2 months after the last dose of study vaccine.
Any person with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome and functional or anatomic asplenia.
Any medical condition that in the judgment of the investigator would prevent the subject from participating in the study.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Marlborough	Massachusetts	01752	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
34963639	Derived	Min JY, Mwakingwe-Omari A, Riley M, Molo LY, Soni J, Girard G, Danier J. The adjuvanted recombinant zoster vaccine co-administered with the 13-valent pneumococcal conjugate vaccine in adults aged >/=50 years: A randomized trial. J Infect. 2022 Apr;84(4):490-498. doi: 10.1016/j.jinf.2021.12.033. Epub 2021 Dec 25.

ID	Title	Description
FG000	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

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 30, 2018	Feb 18, 2021

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group

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.

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.

Posted

Number

95% Confidence Interval

Percentage of subjects

One month post-dose 2 (Month 3)

ID	Title	Description
OG000	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

Units	Counts
Participants	OG000426

Title

Denominators

Categories

Title	Measurements
	OG00099.1(97.6 to 99.7)

Primary

Anti-gE Antibody Concentrations

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)

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.

Posted

Geometric Mean

95% Confidence Interval

mlU/mL

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

ID	Title	Description
OG000	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
OG001	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

Primary

Anti-pneumococcal Antibody Titers

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)

Posted

Geometric Mean

95% Confidence Interval

Titers

At one month post-dose 1 (Month 1)

ID	Title	Description
OG000	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
OG001	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

Primary

Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody

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)

Posted

Geometric Mean

95% Confidence Interval

mlU/mL

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

ID	Title	Description
OG000	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
OG001	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

Primary

Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies

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.

Posted

Geometric Mean

95% Confidence Interval

Titers

At one month post-dose 1 (Month 1)

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Days With Each Solicited Local Symptoms

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

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.

Posted

Median

Inter-Quartile Range

Days

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Days With Solicited General Symptoms

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.

Posted

Median

Inter-Quartile Range

Days

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE)

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End.

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End.

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.

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Angina pectoris	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Angina unstable	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Coronary artery disease	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0011 events1 affected463 at risk
Dressler's syndrome	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Myocardial infarction	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Pericardial effusion	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Pericarditis	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Volvulus	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Appendicitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Diverticulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0012 events1 affected463 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Peritonitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Sepsis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Metastatic carcinoma of the bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Cerebral haematoma	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Pseudolymphoma	Blood and lymphatic system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Palpitations	Cardiac disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Presbyacusis	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Ocular hyperaemia	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Retinal detachment	Eye disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Aphthous ulcer	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Constipation	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Dental caries	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected449 at risk EG0010 events0 affected463 at risk
Enteritis	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG000118 events102 affected449 at risk EG001153 events119 affected463 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Hypoaesthesia oral	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Nausea	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Rectal fissure	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Tongue eruption	Gastrointestinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Administration site pruritus	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Asthenia	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Axillary pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Chills	General disorders	MedDRA 23.1	Systematic Assessment	EG000174 events139 affected449 at risk EG001179 events143 affected463 at risk
Fatigue	General disorders	MedDRA 23.1	Systematic Assessment	EG000361 events243 affected449 at risk EG001448 events261 affected463 at risk
Feeling hot	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0012 events2 affected463 at risk
Influenza like illness	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Injection site bruising	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Injection site erythema	General disorders	MedDRA 23.1	Systematic Assessment	EG000278 events192 affected449 at risk EG001286 events190 affected463 at risk
Injection site hypoaesthesia	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Injection site movement impairment	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Injection site oedema	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Injection site pain	General disorders	MedDRA 23.1	Systematic Assessment	EG000673 events389 affected449 at risk EG001952 events406 affected463 at risk
Injection site pruritus	General disorders	MedDRA 23.1	Systematic Assessment	EG0009 events7 affected449 at risk EG00110 events7 affected463 at risk
Injection site rash	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Injection site reaction	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Injection site swelling	General disorders	MedDRA 23.1	Systematic Assessment	EG000146 events108 affected449 at risk EG001156 events117 affected463 at risk
Injection site warmth	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0012 events2 affected463 at risk
Malaise	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Non-cardiac chest pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Oedema peripheral	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Pain	General disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Peripheral swelling	General disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Pyrexia	General disorders	MedDRA 23.1	Systematic Assessment	EG00026 events23 affected449 at risk EG00132 events29 affected463 at risk
Sensation of foreign body	General disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Hypersensitivity	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Seasonal allergy	Immune system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Anal abscess	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Bronchitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0005 events5 affected449 at risk EG0011 events1 affected463 at risk
Cystitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Ear infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Erysipelas	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Fungal infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Fungal skin infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Gastroenteritis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0013 events3 affected463 at risk
Genital infection fungal	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Herpes simplex	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Impetigo	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Influenza	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0013 events3 affected463 at risk
Injection site cellulitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Laryngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Nasopharyngitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected449 at risk EG0017 events7 affected463 at risk
Oral herpes	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0012 events2 affected463 at risk
Otitis externa	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Otitis media	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Pneumonia	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Pulpitis dental	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Rash pustular	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Sinusitis	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0014 events4 affected463 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0004 events4 affected449 at risk EG0017 events7 affected463 at risk
Urinary tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0012 events2 affected463 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0014 events4 affected463 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0012 events2 affected463 at risk
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0012 events2 affected463 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Mallet finger	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0012 events2 affected463 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0006 events5 affected449 at risk EG00110 events8 affected463 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Axillary mass	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0012 events2 affected463 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG000373 events260 affected449 at risk EG001501 events284 affected463 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0005 events4 affected449 at risk EG0013 events3 affected463 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Burning sensation	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Dizziness	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected449 at risk EG0012 events2 affected463 at risk
Dysgeusia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0013 events1 affected463 at risk
Headache	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG000287 events206 affected449 at risk EG001376 events241 affected463 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Neuralgia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Neuromuscular blockade	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Paraesthesia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Sciatica	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
VIth nerve paresis	Nervous system disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Acute stress disorder	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Depression	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Insomnia	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Restlessness	Psychiatric disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Haematuria	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Urinary retention	Renal and urinary disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected449 at risk EG0012 events2 affected463 at risk
Dry throat	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0002 events1 affected449 at risk EG0010 events0 affected463 at risk
Lower respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0012 events2 affected463 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected449 at risk EG0011 events1 affected463 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Acne	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0011 events1 affected463 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0007 events6 affected449 at risk EG0016 events4 affected463 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0002 events2 affected449 at risk EG0010 events0 affected463 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Peau d'orange	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0003 events2 affected449 at risk EG0012 events2 affected463 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0012 events2 affected463 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Aortic stenosis	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0001 events1 affected449 at risk EG0010 events0 affected463 at risk
Circulatory collapse	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk
Hypertension	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0003 events3 affected449 at risk EG0015 events5 affected463 at risk
Lymphoedema	Vascular disorders	MedDRA 23.1	Systematic Assessment	EG0000 events0 affected449 at risk EG0011 events1 affected463 at risk

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	2	449	16	449	419	449
EG001	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	4	463	16	463	427	463