Study to Evaluate Immunogenicity and Safety Study of GSK... | NCT02045836

ID	Type	Description	Link
2012-005314-19	EudraCT Number

Label	Type	Description	Intervention Names
Co-Ad Group	Experimental	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.	Biological: Herpes Zoster vaccine GSK 1437173A Biological: Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™
Control Group	Active Comparator	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.	Biological: Herpes Zoster vaccine GSK 1437173A Biological: Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™

Name	Type	Description	Arm Group Labels	Other Names
Herpes Zoster vaccine GSK 1437173A	Biological	2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.	Co-Ad Group Control Group

Measure	Description	Time Frame
Number of Subjects With a Vaccine Response for Anti-gE Antibodies	Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response defined as : For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL) For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration	At Month 3
Anti-glicoprotein E (gE) Antibody Concentrations	Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL).	At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)
Anti-pneumococcal Antibody Titers	Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.	At one month post-dose (Month 1)
Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups	The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA).	At 1 month after vaccination
Adjusted GMCs Between Groups	The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations	At 1 month after last vaccine dose

Measure	Description	Time Frame
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) 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.
A male or female aged 50 years or older at the time of the first vaccination with the study vaccine(s).
Written informed consent obtained from the subject.
Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
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 within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. A prednisone dose of < 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as live, inactivated and subunit vaccines.
Administration of long-acting immune-modifying drugs within six months prior to the first vaccine dose or expected administration at any time during the study period.
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 vaccination against Varicella-zoster virus (VZV) or HZ and/or planned administration during the study of an HZ or VZV vaccine other than the study vaccine.
History of HZ.
History of documented pneumococcal infection within 5 previous years.
Prior receipt of any pneumococcal vaccine or planned use of this vaccine during the study period, other than the study vaccine.
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 enrolment.
- Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred route for recording temperature in this study will be oral.
- Subjects with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products within the 3 months preceding 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 persons with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome, and functional or anatomic asplenia.
Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Any condition which, in the judgment of the investigator, would make intramuscular (IM) injection unsafe.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Golden	Colorado	80401	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
29903674	Background	Marechal C, Lal H, Poder A, Ferguson M, Enweonye I, Heineman TC, Herve C, Rheault P, Talli J, Wauters D, Oostvogels L. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine co-administered with the 23-valent pneumococcal polysaccharide vaccine in adults >/=50 years of age: A randomized trial. Vaccine. 2018 Jul 5;36(29):4278-4286. doi: 10.1016/j.vaccine.2018.05.110. Epub 2018 Jun 11.

ID	Title	Description
FG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

ID	Title	Description
BG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
BG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000432 BG001433 BG002865

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

Number of Subjects With a Vaccine Response for Anti-gE Antibodies

Vaccine response rate for anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA), in subjects from the Co-Ad group. Vaccine response defined as : For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL) For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration

This analysis was perfrmed on the According-to-Protocol (ATP) cohort for immunigenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the procedures and intervals allowed for the analysis, not eliminated during the study and for whom data concerning immunogenicity endpoint measures were available.

Posted

Count of Participants

Participants

At Month 3

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Units	Counts
Participants	OG000401

Title

Denominators

Categories

Title	Measurements
	OG000394

Primary

Anti-glicoprotein E (gE) Antibody Concentrations

Antibody concentrations were determined by ELISA, presented as geometric mean concentrations and expressed as milli international units per milliliter (mIU/mL).

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At one month post-dose 2 (Month 3 for the Co-Ad Group and Month 5 for the Control Group)

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Primary

Anti-pneumococcal Antibody Titers

Anti-pneumococcal antibody titers were presented as geometric mean titers (GMTs) for the 12 following serotypes as determined by Opsonophagocytic Assay (OPA): 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F.

Posted

Geometric Mean

95% Confidence Interval

Titers

At one month post-dose (Month 1)

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Primary

Adjusted Ratios of Geometric Mean Titers (GMTs) Between Groups

The Adjusted ratios of GMTs between groups (Control group and Co-Ad group) were presented for each individual pneumococcal conjugate serotype Opsonophagocytic Activity (OPA).

Posted

Geometric Mean

95% Confidence Interval

Titers

At 1 month after vaccination

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Primary

Adjusted GMCs Between Groups

The Adjusted ratios of GMCs between groups (Control group and Co-Ad group) was presented for anti-gE antibody ELISA concentrations

Posted

Geometric Mean

95% Confidence Interval

mIU/mL

At 1 month after last vaccine dose

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Secondary

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

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

The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.

Posted

Count of Participants

Participants

Within 7 days (Days 0 - 6) after each vaccination

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Secondary

Number of Subjects With Solicited Local Symptoms, Across Doses, by Vaccine

The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.

Posted

Count of Participants

Participants

Within 7 days (Days 0 - 6) after vaccination

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Secondary

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

Assessed solicited general symptoms were arthralgia, fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache, myalgia, shivering and sweating. 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.

This analysis was performed on the Total Vaccinated cohort, including subjects with at least one vaccine dose administered, only on those subjects with completed symptom sheets.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Secondary

Number of Days With Any Solicited Local and General Symptoms

The Co-Ad Group received only 2 vaccine doses, hence the number of participants for the Dose 3 categories in this group is 0.

The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.

Posted

Median

Inter-Quartile Range

days

Within 7 days (Days 0 - 6) after each vaccination

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm .
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Secondary

Number of Subjects With Unsolicited Adverse Events (AEs)

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

Posted

Count of Participants

Participants

From the first dose up to 30 days post last vaccination period

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Secondary

Number of Subjects With Serious Adverse Events (SAEs) [From the First Dose up to 30 Days Post Last Vaccination Period]

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.

Posted

Count of Participants

Participants

From the first dose up to 30 days post last vaccination period

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Secondary

Number of Subjects With Serious Adverse Events (SAEs) [From 30 Days Post Last Vaccination up to Study End]

The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.

Posted

Count of Participants

Participants

From 30 days post last vaccination up to study end

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Secondary

Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [From First Vaccination up to 30 Days Post Last Vaccination]

Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.

Posted

Count of Participants

Participants

From first vaccination up to 30 days post last vaccination (Month 0 - Month 3 for the Co-Ad Group & Month 0 - Month 5 for the Control Group)

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Secondary

Number of Subjects With Potential Immune Mediated Diseases (pIMDs) [During the Period Starting After 30 Days Post Last Vaccination up to Study End]

The analyses were performed on the Total Vaccinated cohort, which included all subjects with at least one administered vaccine and with the symptoms sheet filled in.

Posted

Count of Participants

Participants

During the period starting after 30 days post last vaccination up to study end (Month 3 - Month 14 for the Co-Ad Group & Month 5 - Month 16 for the Control Group)

ID	Title	Description
OG000	Co-Ad Group	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.
OG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG0003 events3 affected432 at risk EG0011 events1 affected433 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0002 events2 affected432 at risk EG0011 events1 affected433 at risk
Cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0012 events2 affected433 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Colitis ulcerative	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Gastric ulcer	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Asthenia	General disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Chest pain	General disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0012 events2 affected433 at risk
Sarcoidosis	Immune system disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Bacteraemia	Infections and infestations	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Escherichia urinary tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Gastroenteritis salmonella	Infections and infestations	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Pelvic abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0001 events1 affected432 at risk EG0013 events3 affected433 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Gout	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Angiomyolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Bladder transitional cell carcinoma stage iv	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Carotid artery stenosis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Central nervous system lesion	Nervous system disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Cerebral infarction	Nervous system disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0012 events2 affected433 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Embolic stroke	Nervous system disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Lumbosacral radiculopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Vertebral artery dissection	Nervous system disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Delirium	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Calculus urinary	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Aortic dissection	Vascular disorders	Systematic Assessment	EG0001 events1 affected432 at risk EG0010 events0 affected433 at risk
Arteriosclerosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected432 at risk EG0011 events1 affected433 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	Subjects received one dose of the GSK1437173A study vaccine and one dose of the Pneumovax™ 23 vaccine at Day 0 and a second dose of GSK1437173A study vaccine at Month 2. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.	2	432	17	432	400	432
EG001	Control Group	Subjects received one dose of the Pneumovax™ 23 vaccine at Day 0, one dose of the GSK1437173A study vaccine at Month 2 and a second dose of the GSK1437173A study vaccine at Month 4. GSK1437173A vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Pneumovax™ 23 was administered intramuscularly, in the deltoid region of the dominant arm.	5	433	19	433	393	433

Term	Organ System	Assessment Type	Statistical Information
Gastrointestinal disorder	Gastrointestinal disorders	Systematic Assessment	EG000137 events114 affected432 at risk EG001116 events84 affected433 at risk
Chills	Gastrointestinal disorders	Systematic Assessment	EG000176 events137 affected432 at risk EG001130 events99 affected433 at risk
Fatigue	General disorders	Systematic Assessment	EG000385 events253 affected432 at risk EG001385 events228 affected433 at risk
Pain	General disorders	Systematic Assessment	EG000642 events372 affected432 at risk EG001754 events357 affected433 at risk
Pyrexia	General disorders	Systematic Assessment	EG000138 events112 affected432 at risk EG001110 events97 affected433 at risk
Swelling	General disorders	Systematic Assessment	EG000178 events137 affected432 at risk EG001162 events115 affected433 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG000370 events257 affected432 at risk EG001376 events227 affected433 at risk
Headache	Nervous system disorders	Systematic Assessment	EG000306 events210 affected432 at risk EG001331 events209 affected433 at risk
Erythema	General disorders	Systematic Assessment	EG000330 events234 affected432 at risk EG001297 events194 affected433 at risk