Herpes ZosterPhase 3NCT04091451
Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster
A Phase 3 study testing Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) in people with Herpes Zoster, run by GlaxoSmithKline at 3 sites in Russia.
Trial summary
The purpose of this study was to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who had a previous episode of Herpes Zoster (HZ). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster
- What is being tested?
- Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,430 participants
- Where
- 3 sitesRussia
- Study dates
- 17 Sep 2019to 15 Feb 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject/subject's LAR(s) prior to performance of any study specific procedure.
- A male or female ≥ 50 YOA at the time of the first vaccination.
- Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods:
- Clinically diagnosed HZ:
- OR Laboratory diagnosed HZ: OR
Show all 12Show fewer
- HZ diagnosed by an adjudication committee: Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy 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 for 2 months after completion of the vaccination series.
Who cannot join
- Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation.
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode.
- Chronic antiviral use for HZ prophylaxis.
- History of >1 prior episode of HZ.
Show all 17Show fewer
- A history of disseminated HZ, cutaneous or associated with visceral disease or associated with neurologic disease caused by VZV infection.
- Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids, long-acting immune-modifying agents or immunosuppressive/cytotoxic therapy
- 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 and ending 30 days after the last dose of study vaccine. However, licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine.
- 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 VZV or HZ.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Acute disease and/or fever at the time of enrolment.
- Administration of immunoglobulins and/or any blood products during the period starting 3 months before 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 in the period up to 2 months after completion of the vaccination series.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
GSK Investigational Site
Barnaul, 656043
GSK Investigational Site
Gatchina, 188300
GSK Investigational Site
Moscow, 115478
About this study
Official title: A Phase III, Randomized, Observer-blind, Placebo Controlled, Multicenter Clinical Trial to Assess Herpes Zoster Recurrence and the Reactogenicity, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine (HZ/su) When Administered Intramuscularly on a 0 and 2 Month Schedule to Adults ≥50 Years of Age With a Prior Episode of Herpes Zoster
The purpose of this study was to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who had a previous episode of Herpes Zoster (HZ).
- Conditions
- Herpes Zoster
- Being tested
- Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A), Placebo
- Keywords
- Shingles, Shingles recurrence, HZ, Vaccine response rate
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)Biological
2 doses of HZ/su vaccine were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.
PlaceboDrug
2 doses of Placebo were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.
| Study group | Role | What they receive |
|---|---|---|
| HZ/su Group | Experimental | Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2. Receives: Biological: Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) |
| Placebo Group | Placebo comparator | Participants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate of Confirmed Herpes Zoster (HZ) Cases
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.
Measured: From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)
Secondary outcomes (13)
Incidence Rate of Confirmed HZ Cases
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included PCR and the HZAC determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.
Measured: From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. Grade 3 pain = significant pain at rest, which prevented normal, everyday activities. Grade 3 erythema, swelling = erythema, swelling with a surface diameter greater than (>) 100 millimeters (mm). Grade 3 pruritus = itchy sensation that prevented normal, everyday activities.
Measured: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Duration in Days of Solicited Administration Site Events
Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited administration site events included erythema, pain, pruritus and swelling at the injection site.
Measured: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Assessed solicited systemic events included fatigue, fever (defined as axillary temperature greater than or equal to (>=) 38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia, and shivering. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Grade 3 fever = axillary temperature higher than (>) 39.0°C/102.2°F. Related = event assessed by the investigator as related to the study vaccination.
Measured: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Duration in Days of Solicited Systemic Events
Duration is the number of days in which a participant experienced the symptom within the 7-day solicited follow-up period. Assessed solicited systemic events included fatigue, fever (defined as axillary temperature >=38.0°C/100.4°F), gastrointestinal symptoms, headache, malaise, myalgia and shivering.
Measured: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE is defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as related to the study vaccination.
Measured: Within 30 days after each vaccination (occurring at Day 1 and Month 2)
Number of Participants With Any and Related Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.
Measured: From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs)
pIMDs are defined as 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. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.
Measured: From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With Any and Related SAEs
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Related = SAE assessed by the investigator as related to the study vaccination.
Measured: From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With Any and Related pIMDs
pIMDs are defined as 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. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. Related = pIMD assessed by the investigator as related to the study vaccination.
Measured: From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine
An SAE is defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study participant. Any SAEs related to the investigational vaccine or related to study participation or to a GSK concomitant medication/vaccine as assessed by the investigator are reported.
Measured: From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)
Percentage of Participants With Vaccine Response for Anti-glycoprotein E (Anti-gE) Antibodies as Determined by Enzyme Linked Immunosorbent Assay (ELISA)
Vaccine response for anti-gE antibodies is defined as:
- For initially seronegative participants, anti-gE antibody concentration at post-vaccination >= 4-fold the cut-off value for anti-gE [97 international units per liter (IU/L)].
- For initially seropositive participants, anti-gE antibody concentration at post-vaccination >= 4-fold the pre-vaccination anti-gE antibody concentration.
Measured: At Month 2 and Month 3
Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) as Determined by ELISA
Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in IU/L.
Measured: At Day 1, Month 2 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start17 Sep 2019
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091451
- Sponsor's protocol ID
- 204939
- Other IDs
- 2016-000744-34, 2016
- Status last verified
- Nov 2025
- First submitted
- 3 Sep 2019
- Last updated
- 4 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Publications
Jegede B, Zhou Y, Hawksworth H, Hui DSC, Montenegro Guerra N, Poder A, Ramon JM, Valimaa H, Villanueva-Quintero GD, Mwakingwe-Omari A; Z-062 study group. Herpes zoster recurrence, and safety and immunogenicity of the recombinant zoster vaccine in adults aged >/=50 years with a history of herpes zoster: A phase 3, randomized controlled trial. J Infect. 2025 Sep;91(3):106573. doi: 10.1016/j.jinf.2025.106573. Epub 2025 Aug 6.
PubMed 40780591de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
PubMed 37781954
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Observer-blind, Placebo Controlled, Multicenter Clinical Trial to Assess Herpes Zoster Recurrence and the Reactogenicity, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine (HZ/su) When Administered Intramuscularly on a 0 and 2 Month Schedule to Adults ≥50 Years of Age With a Prior Episode of Herpes Zoster
- ClinicalTrials.gov ID
- NCT04091451
- Acronym / sponsor ID
- 204939
- Conditions
- Herpes Zoster
- Keywords
- Shingles, Shingles recurrence, HZ, Vaccine response rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,430 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Posted 30 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who had a previous episode of Herpes Zoster (HZ).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HZ/su Group | Experimental | Biological: Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)Participants with a prior episode of HZ randomized to the HZ/su group were scheduled to receive 2 doses of HZ/su vaccine, one at Day 1 and one at Month 2. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants with a prior episode of HZ randomized to the Placebo group were scheduled to receive 2 doses of placebo, one at Day 1 and one at Month 2. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects and/or subject's LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject/subject's LAR(s) prior to performance of any study specific procedure.
- A male or female ≥ 50 YOA at the time of the first vaccination.
- Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods:
- OR Laboratory diagnosed HZ: OR
Key exclusion criteria (17 listed)
- Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation.
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode.
- Chronic antiviral use for HZ prophylaxis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)2 doses of HZ/su vaccine were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2. | Biological | HZ/su Group |
| Placebo2 doses of Placebo were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2. | Drug | Placebo Group |
Primary outcome
Incidence Rate of Confirmed Herpes Zoster (HZ) Cases
Time frame: From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)
A suspected case of HZ is defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A suspected case of HZ was confirmed by an algorithm that included Polymerase Chain Reaction (PCR) and the HZ Ascertainment Committee (HZAC) determination. The incidence rate (n/T) of confirmed HZ cases, expressed in terms of 1000 person-years rate, was calculated as the number of participants reporting at least one confirmed HZ case (n) in a group, over the sum of follow-up period expressed in years (T) in the same group, and multiplied by 1000.
13 secondary outcomes
Incidence Rate of Confirmed HZ Cases
Time frame: From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)
Number of Participants With Any and Grade 3 Solicited Administration Site Events
Time frame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Duration in Days of Solicited Administration Site Events
Time frame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Number of Participants With Any, Grade 3 and Related Solicited Systemic Events
Time frame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Duration in Days of Solicited Systemic Events
Time frame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Time frame: Within 30 days after each vaccination (occurring at Day 1 and Month 2)
Number of Participants With Any and Related Serious Adverse Events (SAEs)
Time frame: From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs)
Time frame: From first vaccination (Day 1) to 30 days post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With Any and Related SAEs
Time frame: From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With Any and Related pIMDs
Time frame: From 30 days post-last vaccination until 1 year post-last vaccination (last vaccination administered at Day 1 for participants who received only 1 dose and at Month 2 for participants who received 2 doses)
Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine
Time frame: From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months)
Percentage of Participants With Vaccine Response for Anti-glycoprotein E (Anti-gE) Antibodies as Determined by Enzyme Linked Immunosorbent Assay (ELISA)
Time frame: At Month 2 and Month 3
Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) as Determined by ELISA
Time frame: At Day 1, Month 2 and Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 40780591Jegede B, Zhou Y, Hawksworth H, Hui DSC, Montenegro Guerra N, Poder A, Ramon JM, Valimaa H, Villanueva-Quintero GD, Mwakingwe-Omari A; Z-062 study group. Herpes zoster recurrence, and safety and immunogenicity of the recombinant zoster vaccine in adults aged >/=50 years with a history of herpes zoster: A phase 3, randomized controlled trial. J Infect. 2025 Sep;91(3):106573. doi: 10.1016/j.jinf.2025.106573. Epub 2025 Aug 6.
- Derived from this study: PubMed 37781954de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A) in people with Herpes Zoster, run by GlaxoSmithKline at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate of Confirmed Herpes Zoster (HZ) Cases (time frame: From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04091451, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.