Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

Number of Subjects With Post-herpetic Neuralgia (PHN)

PHN cases in the mTVc.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Number of Days With Severe 'Worst' HZ-associated Pain

Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period as measured by the Zoster Brief Pain Inventory (ZBPI) in subjects with confirmed HZ.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations

The number of subjects with confirmed HZ related mortality and hospitalizations were tabulated.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Number of Subjects With Overall Mortality and HZ-related Mortality

The number of subjects with overall mortality and HZ related mortality were tabulated. Evaluation of VE in the reduction of overall and HZ related mortality as per study objective was not performed due to low number of events reported.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Number of Subjects With Confirmed HZ Episode Related Hospitalizations

Incidence of overall and HZ-related hospitalizations during the study.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Number of Subjects With HZ Related Complications

Incidence of HZ complications during the study in subjects with confirmed HZ.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Number of Subjects Receiving Pain Medication Associated With HZ

Incidence of use of pain medications throughout the study

Time frame: During the entire study period (3 to 5 year period following Day 0)

Number of Days With Pain Medication Associated With HZ

Incidence of reduction of duration of pain medication associated with HZ throughout the study.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects included in the 7-day diary card subset; Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Significant pain at rest that prevented everyday normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.

Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

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

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. 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.

Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

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

Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects. 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.

Time frame: Within the 30 days (Days 0-29) after each vaccination

Number of Subjects With Any and Related Serious Adverse Events (SAEs)

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.

Time frame: From Month 0 to Month 14

Number of Subjects With Fatal Serious Adverse Events (SAEs)

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.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication

The number of subjects with SAEs related to study participation or concomitant GSK medication were tabulated

Time frame: During the entire study period (3 to 5 year period following day 0)

Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)

Occurrence and relationship to vaccination of any potential immune-mediated diseases (pIMDs) during the entire study period in all subjects

Time frame: During the entire study period (3 to 5 year period following Day 0)

Number of Subjects With Any and Related Medically Attended Visits

Occurrence and relationship to vaccination of medically attended visits other than routine health care visits, from Month 0 to Month 8 in all subjects. Medically attended visits were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended visits= Occurrence of any medically attended visits regardless of intensity grade or relation to vaccination.

Time frame: From Month 0 to Month 8 post-vaccination

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA

Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 50 YOA.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ

Occurrence of PHN during the entire study period in all subjects with confirmed HZ.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.

The duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ .

Time frame: During the entire study period (3 to 5 year period following Day 0)

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.

Duration of severe 'worst' HZ-associated pain following the onset of a confirmed HZ rash over the entire pain reporting period was measured by the ZBPI in subjects ≥ 70 YOA with confirmed HZ.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Occurrence, intensity of each solicited local symptom within 7 days (Days 0-6) after each vaccination, in subjects ≥ 70 YOA. 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.

Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = Temperature\> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Time frame: Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA

Occurrence, intensity and relationship to vaccination of unsolicited AEs during 30 days (Days 0-29) after each vaccination, according to the MedDRA classification, in subjects ≥ 70 YOA.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.

Time frame: Within 30 days (Days 0 - 29) after each vaccination

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs

Occurrence and relationship to vaccination of all SAEs from Month 0 to Month 14 in subjects ≥ 70 YOA. Related SAEs also included any SAEs related to study participation or concurrent GSK medication/vaccine.

Time frame: From Month 0 to Month 14

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs

Fatal SAEs during the entire study period in subjects ≥ 70 YOA.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs

Occurrence and relationship to vaccination of any pIMDs during the entire study period in subjects ≥ 70 YOA.

Time frame: During the entire study period (3 to 5 year period following Day 0)

Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits

Occurrence and relationship to vaccination of medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, from Month 0 to Month 8 in subjects ≥ 70 YOA.

Time frame: From Month 0 to Month 8 post-vaccination