Phase 3
Completed N=13,900
Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older
Herpes Zoster · Herpes Zoster Vaccine
Source: ClinicalTrials.gov NCT01165229 ↗
Enrolled (actual)
13,900
Serious AEs
17.0%
Results posted
Nov 2017
Primary outcomePrimary: Number of Subjects With Any Episodes of Herpes Zoster (HZ) — 17; 6; 23; 169 Participants — p=<0.0001
◆ Published Evidence
Established
64citations · ~13 / year
Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials.
Summary
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years.
Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.
Linked Publications (5)
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Efficacy and serious adverse events profile of the adjuvanted recombinant zoster vaccine in adults with pre-existing potential immune-mediated diseases: a pooled post hoc analysis on two parallel randomized trials.
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Post hoc analysis of reactogenicity trends between dose 1 and dose 2 of the adjuvanted recombinant zoster vaccine in two parallel randomized trials.
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The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults ≥ 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials.
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Adjuvanted recombinant zoster vaccine decreases herpes zoster-associated pain and the use of pain medication across 3 randomized, placebo-controlled trials.
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An Analysis of How Herpes Zoster Pain Affects Health-related Quality of Life of Placebo Patients From 3 Randomized Phase III Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Any Episodes of Herpes Zoster (HZ) |
17; 6; 23; 169; 54; 223 | <0.0001 sig |
| PRIMARY Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN) |
2; 2; 4; 29; 7; 36 | <0.0001 sig |
| PRIMARY Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ |
19; 6; 25; 216; 68; 284 | <0.0001 sig |
| SECONDARY Number of Subjects With Post-herpetic Neuralgia (PHN) |
2; 2; 4; 22; 6; 28 | <0.0001 sig |
| SECONDARY Number of Days With Severe 'Worst' HZ-associated Pain |
21.8; 98.7; 34.6; 47.9; 50.4; 48.5 | 0.3749 |
| SECONDARY Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Overall Mortality and HZ-related Mortality |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Confirmed HZ Episode Related Hospitalizations |
0; 0; 0; 3; 2; 5 | 0.2533 |
| SECONDARY Number of Subjects With HZ Related Complications |
1; 0; 1; 6; 4; 10 | 0.4947 |
| SECONDARY Number of Subjects Receiving Pain Medication Associated With HZ |
7; 3; 10; 123; 37; 160 | 0.0112 sig |
| SECONDARY Number of Days With Pain Medication Associated With HZ |
38.7; 274.7; 109.5; 218.6; 135.0; 199.3 | 0.0232 sig |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
297; 26; 12; 1; 143; 3 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
104; 56; 8; 4; 85; 34 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
3859; 2263; 485; 265; 2853; 529 | — |
| SECONDARY Number of Subjects With Any and Related Serious Adverse Events (SAEs) |
891; 939; 12; 7 | — |
| SECONDARY Number of Subjects With Fatal Serious Adverse Events (SAEs) |
426; 459 | — |
| SECONDARY Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication |
57; 84 | — |
| SECONDARY Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs) |
92; 97; 8; 6 | — |
| SECONDARY Number of Subjects With Any and Related Medically Attended Visits |
2882; 2911; 165; 66 | — |
| SECONDARY 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 |
0; 0; 2; 2; 4; 8 | 0.0081 sig |
| SECONDARY 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 |
0; 0; 2; 2; 4; 8 | 1.0000 |
| SECONDARY 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. |
17; 3; 20; 193; 61; 254 | 0.2885 |
| SECONDARY 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. |
20.3; 98.7; 32.1; 48.3; 45.2; 47.5 | — |
| SECONDARY 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 |
1336; 128; 42; 1; 606; 17 | — |
| SECONDARY 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 |
545; 231; 31; 13; 441; 147 | — |
| SECONDARY 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 |
4366; 2732; 553; 335; 2961; 578 | — |
| SECONDARY 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 |
1117; 1171; 12; 7 | — |
| SECONDARY Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs |
128; 144 | — |
| SECONDARY 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 |
110; 118; 8; 8 | — |
| SECONDARY 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 |
3593; 3648; 180; 80 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- A male or female aged 70 years or older at the time of the first vaccination.
Exclusion Criteria
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use 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 product.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy History of HZ.
- Previous vaccination against varicella or HZ.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation.
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
- Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period.
- Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
- Acute disease and/or fever at the time of enrolment.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Data sourced from ClinicalTrials.gov (NCT01165229) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.