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Phase 3 Completed N=15,405 Randomized Triple-blind Prevention

Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and Older

Source: ClinicalTrials.gov NCT01165177 ↗
Enrolled (actual)
15,405
Serious AEs
9.5%
Results posted
May 2017
Primary outcomePrimary: Number of Subjects With Confirmed Herpes Zoster (HZ) Cases — 3; 2; 1; 6 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.
Rheumatology (Oxford, England) · 2021 · Open access · Likely link

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 ≥ 50 years. Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being 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. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.

Linked Publications (5)

  • 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.
    Rheumatology (Oxford, England) · 2021 · 64 citations · Open access · Likely link
  • 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.
    Human vaccines & immunotherapeutics · 2021 · 17 citations · Open access · Likely link
  • Adjuvanted recombinant zoster vaccine decreases herpes zoster-associated pain and the use of pain medication across 3 randomized, placebo-controlled trials.
    Pain · 2023 · 15 citations · Open access · Likely link
  • No Consistent Evidence of Decreased Exposure to Varicella-Zoster Virus Among Older Adults in Countries with Universal Varicella Vaccination.
    The Journal of infectious diseases · 2022 · 12 citations · Open access · Likely link
  • An Analysis of How Herpes Zoster Pain Affects Health-related Quality of Life of Placebo Patients From 3 Randomized Phase III Studies.
    The Clinical journal of pain · 2023 · 7 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
3; 2; 1; 6; 87; 75 <0.0001 sig
SECONDARY
Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)
0; 0; 0; 0; 8; 2 0.0081 sig
SECONDARY
Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain
4; 1; 2; 7; 91; 74
SECONDARY
Number of Subjects With Confirmed HZ Episode Related Mortality
0; 0; 0; 0; 0; 0
SECONDARY
Number of Subjects With HZ Related Complications
0; 0; 0; 0; 1; 3
SECONDARY
Number of Subjects With Confirmed HZ Episode Related Hospitalizations
0; 0; 0; 0; 0; 0
SECONDARY
Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ
3; 2; 1; 6; 82; 63
SECONDARY
Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ
3; 2; 1; 6; 82; 63
SECONDARY
Number of Days With Severe 'Worst' HZ-associated Pain.
12.0; 78.0; 9.0; 20.6; 28.7; 21.6
SECONDARY
Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations
0; 0; 0; 0; 0; 0
SECONDARY
Number of Subjects With HZ Related Complications, by Complication Type
0; 0; 0; 0; 1; 3
SECONDARY
Distribution of Pain Medication Associated With HZ
3; 2; 1; 6; 82; 63
SECONDARY
Number of Days of Pain Medication Associated With HZ
17.3; 20.5; 63.0; 26.0; 49.2; 74.3
SECONDARY
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
3120; 352; 159; 6; 1225; 40
SECONDARY
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
1395; 531; 109; 29; 1153; 355
SECONDARY
Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)
3766; 1691; 759; 145
SECONDARY
Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)
87; 105; 8; 12
SECONDARY
Number of Subjects With AEs With Any and Related Medically Attended Visit
2952; 3072; 142; 60
SECONDARY
Number of Subjects With Unsolicited Adverse Events (AEs)
3534; 2426; 609; 298; 2199; 439
SECONDARY
Number of Subjects With Serious Adverse Events (SAEs)
88; 97; 1; 3; 594; 590
SECONDARY
Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine
43; 25
SECONDARY
Number of Subjects With Fatal SAEs
208; 221

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 50 years or older at the time of the first vaccination;
  • Female subjects of non-childbearing potential may be enrolled in the study;

For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

OR 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 urine 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 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 enrollment;
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Pregnant or lactating female;
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01165177) 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.

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