A Phase 3 interventional study of HZ/su and Placebo in Herpes Zoster, sponsored by GlaxoSmithKline. Completed at 9 sites in India. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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Among 46 studies testing shingrix in Herpes Zoster — 8 open to participants now, 11 under way, 3 of them phase 3. shingrix · Herpes Zoster.
Among the 46 studies testing shingrix in Herpes Zoster, this one is the 21st largest by enrollment, is one of 3 that started in 2022, is one of 22 in phase 3, and was the 34th registered.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
Browse Herpes Zoster studies →8 of the 46 studies testing shingrix in Herpes Zoster are open now, in 5 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Finland
Ages 76+ · Healthy volunteers
Seoul National University Hospital · Sites in Korea, Republic of
Ages 19+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18+ · Healthy volunteers
Loyola University · Sites in United States
University of Colorado, Denver · Sites in United States
Ages 18–70
By country, each count listing its studies:
shingrix: first FDA approval 2017 (Shingrix). What it is approved for, and how studies give it, is on its page →
Of the 37 Herpes Zoster studies recruiting now, 26 (70%) set no upper age limit and 6 (16%) stop at 75 or younger; 3 take children under 18; 13 take healthy volunteers.
This study: 50 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 10 · Phase 3 22 · Phase 4 8
First in 2009; this study’s year is marked. 3 started in 2022.
This study's enrollment of 288 is above the median of 160 across 247 interventional studies indexed under Herpes Zoster.
Median enrollment 239 across the 46 interventional studies. Of the 32 that completed or were terminated, 27 (84%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 46 have an industry lead sponsor. The 10 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
44 studies in Herpes Zoster by GlaxoSmithKline: 3 open now, 5 under way, 1 of them phase 3. Of 39 finished, 34 (87%) have results posted.
Among the 44 studies in Herpes Zoster by GlaxoSmithKline, this one is the 25th largest by enrollment of the 37 interventional ones that give a count, is one of 3 that started in 2022, is one of 25 in phase 3, and was the 40th registered.
GlaxoSmithKline’s Herpes Zoster studies by the year they started, since 2007.
4 of the studies testing shingrix in Herpes Zoster that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05371080Phase 3GlaxoSmithKlineA Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults | 2027-08-23 |
| NCT05580458National Institute of Allergy and Infectious Diseases (NIAID)Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population | 2027-02-01 |
| NCT06162494Ann & Robert H Lurie Children's Hospital of ChicagoRecombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients | 2027-03-31 |
| NCT06569823Dynavax Technologies CorporationSafety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over | 2027-06 |
Add all 4 to your calendar (.ics) → With an account.
Among the 46 studies testing shingrix in Herpes Zoster, from their registry updates:
Among GlaxoSmithKline’s 44 in Herpes Zoster:
This tab as a report to print or save as PDF → With an account.
The purpose of this study was to evaluate the humoral immunogenicity and safety of 2 doses of GSK Biologicals' Herpes Zoster subunit vaccine (HZ/su) administered for the prevention of Herpes Zoster (HZ) in adults aged 50 years of age (YOA) or older from India.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participants of childbearing potential may be enrolled in the study, if the participant:
Exclusion Criteria:
Medical conditions
Prior/Concomitant therapy
[In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is recommended and/or organised by the public health authorities, outside the routine immunisation programme, the time period described above can be reduced if necessary for that vaccine provided it is used according to local governmental recommendations and that the Sponsor is notified accordingly.]
Prior/Concurrent clinical study experience Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an or a non-investigational intervention (drug/ invasive medical device).
Other exclusions
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
Biological: HZ/su
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
Drug: Placebo
Drug page: Shingrix
Two doses of the HZ/su vaccine administered intramuscularly, one each at Day 1 and Month 2.
Two doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) administered intramuscularly, one each at Day 1 and Month 2.
Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE)
A participant with vaccine response for anti-gE was defined as a participant with: * at least a 4-fold greater post-last vaccination anti-gE antibody (Ab) concentration as compared to the pre-vaccination anti-gE Ab concentration, for participants who were seropositive at baseline, or * at least a 4-fold greater post-last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for participants who were seronegative at baseline.
Time frame: At 1 month post-Dose 2 of study intervention administration (Month 3)
Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) and Between-group GMC Ratios
Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as GMCs in milli-international units per milliliter (mIU/mL).
Time frame: At 1 month post-Dose 2 of study intervention administration (Month 3)
Percentage of Participants Reporting Solicited Administration Site Events
The assessed solicited administration site events included injection site erythema, pain, pruritus and swelling.
Time frame: Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2)
Percentage of Participants Reporting Solicited Systemic Events
The assessed solicited systemic events included fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and shivering.
Time frame: Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2)
Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as an AE that was not included in a list of solicited events using a participant diary. Unsolicited events must have been spontaneously communicated by a participant who had signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
Time frame: Within 30 days after any study intervention dose administration (vaccine/placebo administered at Day 1 and Month 2)
Percentage of Participants Reporting Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes.
Time frame: From Dose 1 (Day 1) up to 30 days post-last study intervention dose
Percentage of Participants Reporting Potential Immune-mediated Diseases (pIMDs)
pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Time frame: From Dose 1 (Day 1) up to 30 days post-last study intervention dose
Percentage of Participants Reporting SAEs
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes.
Time frame: From Dose 1 (Day 1) up to study end (Month 8)
Percentage of Participants Reporting pIMDs
pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Time frame: From Dose 1 (Day 1) up to study end (Month 8)
Anti-gE Antibody Concentrations Expressed as GMCs
Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.
Time frame: At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3)
Percentage of Participants Seropositive for Anti-gE Antibodies
A participant seropositive for anti-gE antibodies was defined as a participant whose antibody concentration was greater than or equal to (\>=) the assay cut-off value (97 mIU/mL).
Time frame: At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3)
Mean Geometric Increase (MGI) of Anti-gE Antibody Concentrations
MGI was defined as the geometric mean of the within participant ratios of anti-gE antibody concentration at 1 month post-Dose 2 (Month 3) compared to pre-study intervention administration (Day 1) anti-gE antibody concentration.
Time frame: At 1 month post-Dose 2 of study intervention administration (Month 3) compared to pre-study intervention administration (Day 1)
The study was conducted at 9 centers in India.
| Milestone | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Started | 143 | 145 |
| Completed | 142 | 143 |
| Not completed | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 2 |
A participant with vaccine response for anti-gE was defined as a participant with: * at least a 4-fold greater post-last vaccination anti-gE antibody (Ab) concentration as compared to the pre-vaccination anti-gE Ab concentration, for participants who were seropositive at baseline, or * at least a 4-fold greater post-last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for participants who were seronegative at baseline.
| Percentage of participants | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE) | 85.7 (78.4 to 91.3) | 7.8 (3.8 to 13.8) |
Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as GMCs in milli-international units per milliliter (mIU/mL).
| mIU/mL | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) and Between-group GMC Ratios | 26863.85 (20125.47 to 35858.35) | 1360.48 (1134.23 to 1631.85) |
The assessed solicited administration site events included injection site erythema, pain, pruritus and swelling.
| Percentage of participants | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Erythema, post-Dose 1 | 0 (0 to 2.5) | 0 (0 to 2.5) |
| Erythema, post-Dose 2 | 0.7 (0.0 to 3.9) | 0 (0 to 2.5) |
| Erythema, Across doses | 0.7 (0 to 3.8) | 0 (0 to 2.5) |
| Pain, post-Dose 1 | 53.1 (44.6 to 61.5) | 33.8 (26.2 to 42.1) |
| Pain, post-Dose 2 | 46.5 (38.1 to 55.0) | 37.8 (29.8 to 46.2) |
| Pain, Across doses | 67.1 (58.8 to 74.8) | 49.0 (40.6 to 57.4) |
| Pruritus, post-Dose 1 | 9.1 (4.9 to 15.0) | 8.3 (4.3 to 14.0) |
| Pruritus, post-Dose 2 | 12.7 (7.7 to 19.3) | 6.3 (2.9 to 11.6) |
| Pruritus, Across doses | 20.3 (14.0 to 27.8) | 13.1 (8.1 to 19.7) |
| Swelling, post-Dose 1 | 1.4 (0.2 to 5.0) | 0 (0 to 2.5) |
| Swelling, post-Dose 2 | 0.7 (0.0 to 3.9) | 0 (0 to 2.5) |
| Swelling, Across doses | 2.1 (0.4 to 6.0) | 0 (0 to 2.5) |
The assessed solicited systemic events included fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and shivering.
| Percentage of participants | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Fatigue, post-Dose 1 | 32.2 (24.6 to 40.5) | 15.2 (9.8 to 22.1) |
| Fatigue, post-Dose 2 | 35.2 (27.4 to 43.7) | 14.7 (9.3 to 21.6) |
| Fatigue, Across doses | 44.8 (36.4 to 53.3) | 24.1 (17.4 to 31.9) |
| Fever, post-Dose 1 | 26.6 (19.5 to 34.6) | 6.9 (3.4 to 12.3) |
| Fever, post-Dose 2 | 17.6 (11.7 to 24.9) | 3.5 (1.1 to 8.0) |
| Fever, Across doses | 28.0 (20.8 to 36.1) | 9.7 (5.4 to 15.7) |
| Gastrointestinal symptoms, post-Dose 1 | 4.2 (1.6 to 8.9) | 2.1 (0.4 to 5.9) |
| Gastrointestinal symptoms, post-Dose 2 | 2.8 (0.8 to 7.1) | 0.7 (0.0 to 3.8) |
| Gastrointestinal symptoms, Across doses | 7.0 (3.4 to 12.5) | 2.8 (0.8 to 6.9) |
| Headache, post-Dose 1 | 16.1 (10.5 to 23.1) | 13.1 (8.1 to 19.7) |
| Headache, post-Dose 2 | 20.4 (14.1 to 28.0) | 11.9 (7.1 to 18.4) |
| Headache, Across doses | 28.7 (21.4 to 36.8) | 22.8 (16.2 to 30.5) |
| Myalgia, post-Dose 1 | 16.8 (11.1 to 23.9) | 2.8 (0.8 to 6.9) |
| Myalgia, post-Dose 2 | 13.4 (8.3 to 20.1) | 0.7 (0.0 to 3.8) |
| Myalgia, Across doses | 22.4 (15.8 to 30.1) | 3.4 (1.1 to 7.9) |
| Shivering, post-Dose 1 | 4.9 (2.0 to 9.8) | 4.1 (1.5 to 8.8) |
| Shivering, post-Dose 2 | 4.9 (2.0 to 9.9) | 1.4 (0.2 to 5.0) |
| Shivering, Across doses | 8.4 (4.4 to 14.2) | 5.5 (2.4 to 10.6) |
An unsolicited AE was defined as an AE that was not included in a list of solicited events using a participant diary. Unsolicited events must have been spontaneously communicated by a participant who had signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
| Percentage of participants | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Percentage of Participants Reporting Unsolicited Adverse Events (AEs) | 13.3 (8.2 to 20.0) | 13.1 (8.1 to 19.7) |
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes.
| Percentage of participants | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Percentage of Participants Reporting Serious Adverse Events (SAEs) | 0.7 (0.0 to 3.8) | 0 (0 to 2.5) |
pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
| Percentage of participants | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Percentage of Participants Reporting Potential Immune-mediated Diseases (pIMDs) | 0 (0 to 2.5) | 0 (0 to 2.5) |
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes.
| Percentage of participants | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Percentage of Participants Reporting SAEs | 0.7 (0.0 to 3.8) | 1.4 (0.2 to 4.9) |
pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
| Percentage of participants | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Percentage of Participants Reporting pIMDs | 0 (0 to 2.5) | 0 (0 to 2.5) |
Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.
| mIU/mL | HZ/suSeq Group | Placebo Group |
|---|---|---|
| At Day 1 | 1210.86 (982.17 to 1492.79) | 1217.81 (1019.01 to 1455.39) |
| At Month 3 | 26863.85 (20125.47 to 35858.35) | 1360.48 (1134.23 to 1631.85) |
A participant seropositive for anti-gE antibodies was defined as a participant whose antibody concentration was greater than or equal to (\>=) the assay cut-off value (97 mIU/mL).
| Percentage of participants | HZ/suSeq Group | Placebo Group |
|---|---|---|
| At Day 1 | 97.6 (93.2 to 99.5) | 96.9 (92.3 to 99.1) |
| At Month 3 | 99.2 (95.7 to 100.0) | 100 (97.2 to 100) |
MGI was defined as the geometric mean of the within participant ratios of anti-gE antibody concentration at 1 month post-Dose 2 (Month 3) compared to pre-study intervention administration (Day 1) anti-gE antibody concentration.
| Ratio | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Mean Geometric Increase (MGI) of Anti-gE Antibody Concentrations | 22.19 (15.46 to 31.83) | 1.12 (0.92 to 1.36) |
Collected over Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HZ/suSeq Group | 0/143 (0%) | 1/143 (0.7%) | 103/143 (72%) |
| Placebo Group | 0/145 (0%) | 2/145 (1.4%) | 88/145 (60.7%) |
| Event | HZ/suSeq Group | Placebo Group |
|---|---|---|
| PneumoniaInfections and infestations | 1/143 | 0/145 |
| Accidental poisoningInjury, poisoning and procedural complications | 0/143 | 1/145 |
| Head injuryInjury, poisoning and procedural complications | 0/143 | 1/145 |
| Event | HZ/suSeq Group | Placebo Group |
|---|---|---|
| Administration site painGeneral disorders | 96/143 | 71/145 |
| FatigueGeneral disorders | 64/143 | 36/145 |
| PyrexiaGeneral disorders | 42/143 | 16/145 |
| HeadacheNervous system disorders | 42/143 | 37/145 |
| MyalgiaMusculoskeletal and connective tissue disorders | 34/143 | 7/145 |
| PruritusSkin and subcutaneous tissue disorders | 29/143 | 19/145 |
| ChillsGeneral disorders | 12/143 | 8/145 |
| Gastrointestinal disorderGastrointestinal disorders | 10/143 | 4/145 |
| DiarrhoeaGastrointestinal disorders | 3/143 | 8/145 |
| VomitingGastrointestinal disorders | 3/143 | 2/145 |
| Age, Continuous(Years) | HZ/suSeq Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 58.9 ± 7.2 | 58.2 ± 7.0 | 58.5 ± 7.1 |
| Sex: Female, Male(Participants) | HZ/suSeq Group | Placebo Group | Total |
|---|---|---|---|
| Female | 44 | 48 | 92 |
| Male | 99 | 97 | 196 |
| Race/Ethnicity, Customized(Participants) | HZ/suSeq Group | Placebo Group | Total |
|---|---|---|---|
| ASIAN - CENTRAL / SOUTH ASIAN HERITAGE | 140 | 141 | 281 |
| ASIAN - SOUTH EAST ASIAN HERITAGE | 3 | 4 | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk-studyregister.com
Ran from Feb 2022 to primary completion in Oct 2022, 8 months.
Results were first posted in Apr 2024, 1 year 5 months after primary completion.
Of 33 industry-sponsored phase 3 interventional studies under Herpes Zoster, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 45. This study's 8 months is below that.
Counting every sponsor, half of 40 studies reached it within 16 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Shingrix