Trial · NCT04091451
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
NCT04091451, Phase 3, Completed, GlaxoSmithKline; results first posted 2025-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT04091451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04091451
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT04091451
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,430 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Herpes Zoster
- Interventions
- Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A), Placebo
- First posted
- 2019-09-16
- Last updated
- 2025-12-04
- Other registries' IDs
- eudract:2016-000744-34
- Results first posted
- 2025-03-30
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence Rate of Confirmed Herpes Zoster (HZ) Cases | 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. |
| Secondary | Incidence Rate of Confirmed HZ Cases | From first vaccination (Day 1) 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 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. |
| Secondary | Number of Participants With Any and Grade 3 Solicited Administration Site Events | Within 7 days after each vaccination (occurring at Day 1 and Month 2) | 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. |
| Secondary | Duration in Days of Solicited Administration Site Events | Within 7 days after each vaccination (occurring at Day 1 and Month 2) | 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. |
| Secondary | Number of Participants With Any, Grade 3 and Related Solicited Systemic Events | Within 7 days after each vaccination (occurring at Day 1 and Month 2) | 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. |
| Secondary | Duration in Days of Solicited Systemic Events | Within 7 days after each vaccination (occurring at Day 1 and Month 2) | 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. |
| Secondary | Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within 30 days after each vaccination (occurring at Day 1 and Month 2) | 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. |
| Secondary | Number of Participants With Any and Related Serious Adverse Events (SAEs) | 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) | 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. |
| Secondary | Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs) | 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) | 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. |
| Secondary | Number of Participants With Any and Related SAEs | 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) | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence Rate of Confirmed Herpes Zoster (HZ) Cases | From 30 days post-second vaccination (Month 3) until study end (duration of approximately 2 years to 4 years and 5 months) | The analysis was performed on the modified Exposed Set (mES), which excluded participants from the Exposed Set who were not administered 2 doses of the study treatment per protocol, or who developed a confirmed case of HZ prior to 30 days after the second vaccination. | Cases per 1000 person-years | NUMBER |
| SECONDARY | Incidence Rate of Confirmed HZ Cases | From first vaccination (Day 1) until study end (duration of approximately 2 years to 4 years and 5 months) | The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered. | Cases per 1000 person-years | NUMBER |
| SECONDARY | Number of Participants With Any and Grade 3 Solicited Administration Site Events | Within 7 days after each vaccination (occurring at Day 1 and Month 2) | The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and with the solicited administration site events diary card data available after the corresponding vaccination for the specified duration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration in Days of Solicited Administration Site Events | Within 7 days after each vaccination (occurring at Day 1 and Month 2) | The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered, with solicited diary data available after the corresponding vaccination and who experienced the specified solicited administration site event within 7 days following the respective study treatment dose. Here, 'number analyzed' = participants with available data for each specified category. | Days | MEDIAN |
| SECONDARY | Number of Participants With Any, Grade 3 and Related Solicited Systemic Events | Within 7 days after each vaccination (occurring at Day 1 and Month 2) | The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and with the solicited systemic events diary card data available after the corresponding vaccination for the specified duration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration in Days of Solicited Systemic Events | Within 7 days after each vaccination (occurring at Day 1 and Month 2) | The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered, with solicited diary data available after the corresponding vaccination and who experienced the specified solicited systemic event within 7 days following the respective study treatment dose. Here, 'number analyzed' = participants with available data for each specified category. | Days | MEDIAN |
| SECONDARY | Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Within 30 days after each vaccination (occurring at Day 1 and Month 2) | The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom unsolicited AEs data were available for the specified duration after each vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any and Related Serious Adverse Events (SAEs) | 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) | The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom SAEs data were available for the specified duration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs) | 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) | The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom pIMDs data were available for the specified duration. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any and Related SAEs | 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) | The analysis was performed on the Exposed Set, which included all participants with at least one dose of the study treatment administered and for whom SAEs data were available for the specified duration. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group203
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence Rate of Confirmed Herpes Zoster (HZ) Cases | HZ/su Group | 0.0 | Cases per 1000 person-years | ||
| Incidence Rate of Confirmed Herpes Zoster (HZ) Cases | Placebo Group | 4.1 | Cases per 1000 person-years | ||
| Incidence Rate of Confirmed HZ Cases | HZ/su Group | 0.0 | Cases per 1000 person-years | ||
| Incidence Rate of Confirmed HZ Cases | Placebo Group | 3.6 | Cases per 1000 person-years | ||
| Number of Participants With Any and Grade 3 Solicited Administration Site Events | HZ/su Group | Any Erythema, post-vaccination at Day 1 | 164 | Participants | |
| Number of Participants With Any and Grade 3 Solicited Administration Site Events | Placebo Group | Any Erythema, post-vaccination at Day 1 | 5 | Participants | |
| Number of Participants With Any and Grade 3 Solicited Administration Site Events | HZ/su Group | Grade 3 Erythema, post-vaccination at Day 1 | 8 | Participants | |
| Number of Participants With Any and Grade 3 Solicited Administration Site Events | Placebo Group | Grade 3 Erythema, post-vaccination at Day 1 | 0 | Participants | |
| Number of Participants With Any and Grade 3 Solicited Administration Site Events | HZ/su Group | Any Pain, post-vaccination at Day 1 | 562 | Participants | |
| Number of Participants With Any and Grade 3 Solicited Administration Site Events | Placebo Group | Any Pain, post-vaccination at Day 1 | 61 | Participants |
1 to 10 of 203Source ClinicalTrials.gov
See all 203 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | HZ/su Group | 714 | |
| Overall Study | STARTED | Placebo Group | 712 | |
| Overall Study | COMPLETED | HZ/su Group | 646 | |
| Overall Study | COMPLETED | Placebo Group | 640 | |
| Overall Study | NOT COMPLETED | HZ/su Group | 68 | |
| Overall Study | NOT COMPLETED | Placebo Group | 72 |
Source ClinicalTrials.gov
Adverse events732
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Administration site pain | General disorders | HZ/su Group | 611 | 714 | 1,065 |
| other | Administration site pain | General disorders | Placebo Group | 94 | 712 | 109 |
| other | Fatigue | General disorders | HZ/su Group | 457 | 714 | 695 |
| other | Fatigue | General disorders | Placebo Group | 199 | 712 | 262 |
| other | Malaise | General disorders | HZ/su Group | 396 | 714 | 584 |
| other | Malaise | General disorders | Placebo Group | 112 | 712 | 139 |
| other | Chills | General disorders | HZ/su Group | 330 | 714 | 440 |
| other | Chills | General disorders | Placebo Group | 64 | 712 | 76 |
| other | Administration site erythema | General disorders | HZ/su Group | 238 | 714 | 328 |
| other | Administration site erythema | General disorders | Placebo Group | 5 | 712 | 5 |
1 to 10 of 732Source ClinicalTrials.gov
See all 732 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | HZ/su Group | 12 | 714 |
| Total, all-cause mortality | Placebo Group | 8 | 712 |
| Total, other adverse events | HZ/su Group | 665 | 714 |
| Total, other adverse events | Placebo Group | 414 | 712 |
| Total, serious adverse events | HZ/su Group | 56 | 714 |
| Total, serious adverse events | Placebo Group | 43 | 712 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| HZ/su Group vs Placebo Group: Number of Participants With SAEs Related to Investigational Vaccine, Related to Study Participation or to GSK Concomitant Medication/Vaccine | Trial comparisons |
| HZ/su Group vs Placebo Group: deaths from any cause | Trial comparisons |
| HZ/su Group vs Placebo Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04091451
GET https://conductscience.org/api/trials/v1/NCT04091451/results?page=2