Your session is about to expire
← Back to Search
Virus Therapy
A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults
Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in zoster-006/022 studies
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial is studying a vaccine to prevent shingles in older adults by helping their immune systems fight the virus that causes the disease.
Eligible Conditions
- Shingles
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in zoster-006/022 studies
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at years 5, 6, 7, 8, 9, 10, 11 and 12 after the primary vaccination in zoster-006/022 studies
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants Having at Least One Confirmed Herpes Zoster (HZ) Case During the Total Duration of ZOSTER-049:EXT 006-022 Study, Overall
Secondary study objectives
Anti-gE Antibody Concentrations for 1 Additional Dose, Revaccination and Control Groups at Month 0 and Years 1, 2, 3, 4, 5 and 6 in the Current ZOSTER-049:EXT 006-022 Study
Anti-gE Antibody Concentrations for 1-Additional Dose, Revaccination and Control Groups at Month 1 in the Current ZOSTER-049:EXT 006-022 Study
Anti-gE Antibody Concentrations for Participants in LTFU+Control >=50 YOA Group (With a Confirmed HZ Episode) at Years 5, 6, 7, 8, 9, 10, 11 and 12 After the Primary Vaccination in ZOSTER-006/022 Studies
+22 moreSide effects data
From 2019 Phase 3 trial • 8687 Patients • NCT0269020737%
Injection site pain
15%
Injection site erythema
12%
Pyrexia
11%
Injection site swelling
8%
Headache
4%
Fatigue
4%
Chills
4%
Myalgia
3%
Malaise
3%
Injection site pruritus
3%
Nasopharyngitis
2%
Pain
2%
Injection site warmth
2%
Arthralgia
2%
Vaccination site pain
2%
Nausea
1%
Diarrhoea
1%
Back pain
1%
Pruritus
1%
Dizziness
1%
Injection site inflammation
1%
Influenza
1%
Body temperature increased
1%
Feeling cold
1%
Administration site pain
1%
Asthenia
1%
Influenza like illness
1%
Injection site induration
1%
Injection site rash
1%
Pain in extremity
1%
Rash
1%
Pneumonia
1%
Vaccination site erythema
1%
Upper respiratory tract infection
1%
Urinary tract infection
1%
Musculoskeletal pain
1%
Cough
1%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
HZ/su Group
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Revaccination GroupExperimental Treatment1 Intervention
Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies were revaccinated with 2 additional doses of the HZ/su vaccine at Month 0 and Month 2 in the current ZOSTER-049:EXT 006-022 study.
Group II: 1-Additional Dose GroupExperimental Treatment1 Intervention
Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies received 1 additional dose of the HZ/su vaccine at Month 0 in the current ZOSTER-049:EXT 006-022 study.
Group III: Control GroupActive Control1 Intervention
Participants who received 2 doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study, but who served as a control for the 2 groups that received 1 or 2 additional doses (1-Additional Dose Group and Revaccination Group).
Group IV: LTFU GroupActive Control1 Intervention
Participants who received at least 1 dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the current ZOSTER-049:EXT 006-022 study were followed up for long-term vaccine efficacy and safety.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Herpes Zoster Vaccine GSK1437173A
2016
Completed Phase 3
~47400
Find a Location
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,812 Previous Clinical Trials
8,374,714 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,605 Previous Clinical Trials
6,137,537 Total Patients Enrolled