A Phase 4 interventional study of RZV and Placebo in Herpes Zoster, sponsored by GlaxoSmithKline. Completed at 6 sites in China. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-20.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention
The purpose of this study was to assess vaccine efficacy (VE), ability to generate immune response and safety of two doses of the recombinant subunit zoster vaccine (RZV) for prevention of Herpes Zoster (HZ) in Chinese adults aged 50 years and older.
360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.
This study's enrollment of 6,138 is above the median of 250 across 299 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female participants of childbearing potential may be enrolled in the study, if the subject
Exclusion Criteria:
Medical conditions
Prior/Concomitant therapy
Prior/Concurrent clinical study experience
Other exclusions
Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2.
Biological: RZV
Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2.
Drug: Placebo
2 doses of RZV in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm
2 doses of placebo in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm
Incidence Rate of Confirmed Herpes Zoster (HZ) Cases
A suspected case of HZ was defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) or by 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.
Time frame: From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years)
Incidence Rate of Confirmed HZ Cases, by Age Category
A suspected case of HZ was defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR or by 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. The age categories assessed were 50-69 and greater than or equal to (\>=) 70 years of age (YOA).
Time frame: From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years)
Number of Participants With Any and at Least Grade 3 Solicited Local Adverse Events (AEs) (as Per GSK's Standard Grading Scale) and With Solicited Local AEs Resulting in a Medically Attended Visit
Assessed solicited local AEs included erythema, pain and swelling at injection site. The intensity of a solicited local AE was scored at GSK by using GSK's standard grading scale as follows: Any AE = occurrence of the event regardless of intensity grade. At least Grade 3 AE = occurrence of an at least Grade 3 or Grade 4 event (Grade 4 defined for some solicited AEs collected in the study as required by Chinese grading scale). Maximum of Grade 3 and 4 was considered as Grade 3 for all applicable solicited symptoms in GSK standard grading table. AE resulting in a medically attended visit = event for which the participant received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
Time frame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Number of Participants With Any, at Least Grade 3 (as Per GSK's Standard Grading Scale) and Related Solicited General AEs and With Solicited General AEs Resulting in a Medically Attended Visit
Assessed solicited general AEs included fatigue, fever, gastrointestinal symptoms (nausea, vomiting and/or abdominal pain) headache, myalgia, and shivering. The intensity of a solicited general AE was scored at GSK by using GSK's standard grading scale as follows: Any AE = occurrence of the event regardless of intensity grade or relation to vaccination. At least Grade 3 AE = occurrence of an at least Grade 3 or Grade 4 event (Grade 4 defined for some solicited AEs collected in the study as required by Chinese grading scale). Maximum of Grade 3 and 4 was considered as Grade 3 for all applicable solicited symptoms in GSK standard grading table. Related AE = event assessed by the investigator as related to vaccination. AE resulting in a medically attended visit = event for which the participant received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
Time frame: Within 7 days after each vaccination (occurring at Day 1 and Month 2)
Number of Participants With at Least One Unsolicited AE, at Least One Grade 3 Unsolicited AE, at Least One Related Unsolicited AE, at Least One Grade 3 Related Unsolicited AE and With at Least One Medically Attended Unsolicited AE
An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study, or any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms. At least one unsolicited AE = at least one event regardless of intensity grade or relation to study vaccination. At least one Grade 3 unsolicited AE = at least one event that prevented normal, everyday activities. At least one related unsolicited AE = at least one event assessed by the investigator as related to the study vaccination. At least one Grade 3 related unsolicited AE = at least one event that prevented normal, everyday activities assessed by the investigator as related to the study vaccination. At least one medically attended unsolicited AE = at least one event for which the participant received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
Time frame: Within 30 days after any vaccination (occurring at Day 1 and Month 2)
Number of Participants With at Least One Serious Adverse Event (SAE) and With at Least One Related SAE From First Vaccination (Day 1) up to 30 Days Post Last Vaccination
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one SAE = at least one SAE regardless of relation to study vaccination. At least one related SAE = at least one SAE assessed by the investigator as related to the study vaccination.
Time frame: From first vaccination (Day 1) up 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 at Least One SAE and With at Least One Related SAE From First Vaccination (Day 1) up to 12 Months Post Last Vaccination
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one SAE = at least one SAE regardless of relation to study vaccination. At least one related SAE = at least one SAE assessed by the investigator as related to the study vaccination.
Time frame: From first vaccination (Day 1) up to 12 months 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 at Least One Related SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years)
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one related SAE = at least one SAE assessed by the investigator as related to the study vaccination.
Time frame: From first vaccination (Day 1) up to study end (duration of approximately 2 years)
Number of Participants With at Least One SAE Related to Study Participation or to GlaxoSmithKline Concomitant Medication/Vaccine
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. SAEs related to study participation (and not to the study vaccine) or to GSK concomitant medication/vaccine were assessed.
Time frame: From the time the participant consented to participate in the study (Day 1) up to study end (duration of approximately 2 years)
Number of Participants With at Least One Fatal SAE and at Least One Related Fatal SAE From First Vaccination (Day 1) up to 30 Days Post Last Vaccination
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one fatal SAE = at least one fatal SAE regardless of relation to study vaccination. At least one related fatal SAE = at least one fatal SAE assessed by the investigator as related to the study vaccination.
Time frame: From first vaccination (Day 1) up 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 at Least One Fatal SAE and With at Least One Related Fatal SAE From First Vaccination (Day 1) up to 12 Months Post Last Vaccination
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one fatal SAE = at least one fatal SAE regardless of relation to study vaccination. At least one related fatal SAE = at least one fatal SAE assessed by the investigator as related to the study vaccination.
Time frame: From first vaccination (Day 1) up to 12 months 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 at Least One Related Fatal SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years)
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one related fatal SAE = at least one fatal SAE assessed by the investigator as related to the study vaccination.
Time frame: From first vaccination (Day 1) up to study end (duration of approximately 2 years)
Number of Participants With at Least One Potential Immune-mediated Disease (pIMD) and at Least One Related pIMD From First Vaccination (Day 1) up to 30 Days Post Last Vaccination
pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. At least one pIMD = at least one pIMD regardless of relation to vaccination. At least one related pIMD = at least one pIMD assessed by the investigator as related to the study vaccination.
Time frame: From first vaccination (Day 1) up 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 at Least One pIMD and at Least One Related pIMD From First Vaccination (Day 1) up to 12 Months Post Last Vaccination
pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. At least one pIMD = at least one pIMD regardless of relation to study vaccination. At least one related pIMD = at least one related pIMD assessed by the investigator as related to the study vaccination.
Time frame: From first vaccination (Day 1) up to 12 months 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 at Least One Related Serious pIMD From 12 Months Post Last Vaccination up to Study End (Duration of Approximately 1 Year)
pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. At least one related serious pIMD = at least one serious pIMD assessed by the investigator as related to the study vaccination.
Time frame: From 12 months 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) up to study end (duration of approximately 1 year)
The study was conducted at 6 centers in China.
| Milestone | RZV Group | Placebo Group |
|---|---|---|
| Started | 3064 | 3064 |
| Completed | 3040 | 3048 |
| Not completed | 24 | 16 |
| Withdrew: Consent withdrawal, not due to a (s)ae | 7 | 2 |
| Withdrew: Migrated / moved from the study area | 1 | 1 |
| Withdrew: Adverse event requiring expedited reporting | 13 | 11 |
| Withdrew: Unsolicited non-serious adverse event | 1 | 1 |
| Withdrew: Solicited adverse event | 2 | 1 |
A suspected case of HZ was defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A confirmed case of HZ was diagnosed by Polymerase Chain Reaction (PCR) or by 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.
| Cases per 1000 person-years | RZV Group | Placebo Group |
|---|---|---|
| Incidence Rate of Confirmed Herpes Zoster (HZ) Cases | 0.0 | 8.2 |
A suspected case of HZ was defined as a new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis. A confirmed case of HZ was diagnosed by PCR or by 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. The age categories assessed were 50-69 and greater than or equal to (\>=) 70 years of age (YOA).
| Cases per 1000 person-years | RZV Group | Placebo Group |
|---|---|---|
| 50-69 YOA | 0.0 | 7.4 |
| >=70 YOA | 0.0 | 11.4 |
Assessed solicited local AEs included erythema, pain and swelling at injection site. The intensity of a solicited local AE was scored at GSK by using GSK's standard grading scale as follows: Any AE = occurrence of the event regardless of intensity grade. At least Grade 3 AE = occurrence of an at least Grade 3 or Grade 4 event (Grade 4 defined for some solicited AEs collected in the study as required by Chinese grading scale). Maximum of Grade 3 and 4 was considered as Grade 3 for all applicable solicited symptoms in GSK standard grading table. AE resulting in a medically attended visit = event for which the participant received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| Any Erythema, post-vaccination at Day 1 | 600 | 14 |
| At least Grade 3 Erythema, post-vaccination at Day 1 | 25 | 0 |
| Medically attended visit Erythema, post-vaccination at Day 1 | 8 | 0 |
| Any Pain, post-vaccination at Day 1 | 2045 | 217 |
| At least Grade 3 Pain, post-vaccination at Day 1 | 78 | 3 |
| Medically attended visit Pain, post-vaccination at Day 1 | 18 | 0 |
| Any Swelling, post-vaccination at Day 1 | 705 | 18 |
| At least Grade 3 Swelling, post-vaccination at Day 1 | 19 | 0 |
| Medically attended visit Swelling, post-vaccination at Day 1 | 11 | 0 |
| Any Erythema, post-vaccination at Month 2 | 375 | 9 |
| At least Grade 3 Erythema, post-vaccination at Month 2 | 7 | 0 |
| Medically attended visit Erythema, post-vaccination at Month 2 | 4 | 0 |
| Any Pain, post-vaccination at Month 2 | 1255 | 99 |
| At least Grade 3 Pain, post-vaccination at Month 2 | 31 | 0 |
| Medically attended visit Pain, post-vaccination at Month 2 | 10 | 1 |
| Any Swelling, post-vaccination at Month 2 | 388 | 8 |
| At least Grade 3 Swelling, post-vaccination at Month 2 | 5 | 0 |
| Medically attended visit Swelling, post-vaccination at Month 2 | 5 | 0 |
Assessed solicited general AEs included fatigue, fever, gastrointestinal symptoms (nausea, vomiting and/or abdominal pain) headache, myalgia, and shivering. The intensity of a solicited general AE was scored at GSK by using GSK's standard grading scale as follows: Any AE = occurrence of the event regardless of intensity grade or relation to vaccination. At least Grade 3 AE = occurrence of an at least Grade 3 or Grade 4 event (Grade 4 defined for some solicited AEs collected in the study as required by Chinese grading scale). Maximum of Grade 3 and 4 was considered as Grade 3 for all applicable solicited symptoms in GSK standard grading table. Related AE = event assessed by the investigator as related to vaccination. AE resulting in a medically attended visit = event for which the participant received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| Any Fatigue, post-vaccination at Day 1 | 1070 | 131 |
| At least Grade 3 Fatigue, post-vaccination at Day 1 | 56 | 3 |
| Related Fatigue, post-vaccination at Day 1 | 1058 | 127 |
| Medically attended visit Fatigue, post-vaccination at Day 1 | 20 | 2 |
| Any Fever, post-vaccination at Day 1 | 260 | 14 |
| At least Grade 3 Fever, post-vaccination at Day 1 | 12 | 0 |
| Related Fever, post-vaccination at Day 1 | 259 | 14 |
| Medically attended visit Fever, post-vaccination at Day 1 | 10 | 3 |
| Any Gastrointestinal symptoms, post-vaccination at Day 1 | 331 | 51 |
| At least Grade 3 Gastrointestinal symptoms, post-vaccination at Day 1 | 11 | 1 |
| Related Gastrointestinal symptoms, post-vaccination at Day 1 | 322 | 44 |
| Medically attended visit Gastrointestinal symptoms, post-vaccination at Day 1 | 8 | 5 |
| Any Headache, post-vaccination at Day 1 | 746 | 74 |
| At least Grade 3 Headache, post-vaccination at Day 1 | 37 | 1 |
| Related Headache, post-vaccination at Day 1 | 738 | 69 |
| Medically attended visit Headache, post-vaccination at Day 1 | 16 | 2 |
| Any Myalgia, post-vaccination at Day 1 | 602 | 55 |
| At least Grade 3 Myalgia, post-vaccination at Day 1 | 32 | 2 |
| Related Myalgia, post-vaccination at Day 1 | 593 | 55 |
| Medically attended visit Myalgia, post-vaccination at Day 1 | 6 | 1 |
| Any Shivering, post-vaccination at Day 1 | 351 | 12 |
| At least Grade 3 Shivering, post-vaccination at Day 1 | 6 | 0 |
| Related Shivering, post-vaccination at Day 1 | 347 | 12 |
| Medically attended visit Shivering, post-vaccination at Day 1 | 7 | 1 |
| Any Fatigue, post-vaccination at Month 2 | 797 | 44 |
| At least Grade 3 Fatigue, post-vaccination at Month 2 | 32 | 0 |
| Related Fatigue, post-vaccination at Month 2 | 793 | 44 |
| Medically attended visit Fatigue, post-vaccination at Month 2 | 10 | 0 |
| Any Fever, post-vaccination at Month 2 | 284 | 6 |
| At least Grade 3 Fever, post-vaccination at Month 2 | 14 | 0 |
| Related Fever, post-vaccination at Month 2 | 283 | 6 |
| Medically attended visit Fever, post-vaccination at Month 2 | 7 | 1 |
| Any Gastrointestinal symptoms, post-vaccination at Month 2 | 190 | 20 |
| At least Grade 3 Gastrointestinal symptoms, post-vaccination at Month 2 | 1 | 1 |
| Related Gastrointestinal symptoms, post-vaccination at Month 2 | 186 | 19 |
| Medically attended visit Gastrointestinal symptoms, post-vaccination at Month 2 | 7 | 2 |
| Any Headache, post-vaccination at Month 2 | 575 | 26 |
| At least Grade 3 Headache, post-vaccination at Month 2 | 20 | 0 |
| Related Headache, post-vaccination at Month 2 | 573 | 26 |
| Medically attended visit Headache, post-vaccination at Month 2 | 10 | 2 |
| Any Myalgia, post-vaccination at Month 2 | 464 | 21 |
| At least Grade 3 Myalgia, post-vaccination at Month 2 | 20 | 0 |
| Related Myalgia, post-vaccination at Month 2 | 464 | 21 |
| Medically attended visit Myalgia, post-vaccination at Month 2 | 8 | 0 |
| Any Shivering, post-vaccination at Month 2 | 334 | 4 |
| At least Grade 3 Shivering, post-vaccination at Month 2 | 12 | 0 |
| Related Shivering, post-vaccination at Month 2 | 333 | 4 |
| Medically attended visit Shivering, post-vaccination at Month 2 | 5 | 0 |
An unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study, or any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms. At least one unsolicited AE = at least one event regardless of intensity grade or relation to study vaccination. At least one Grade 3 unsolicited AE = at least one event that prevented normal, everyday activities. At least one related unsolicited AE = at least one event assessed by the investigator as related to the study vaccination. At least one Grade 3 related unsolicited AE = at least one event that prevented normal, everyday activities assessed by the investigator as related to the study vaccination. At least one medically attended unsolicited AE = at least one event for which the participant received medical attention defined as hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| At least one unsolicited AE | 124 | 97 |
| At least one Grade 3 unsolicited AE | 8 | 10 |
| At least one related unsolicited AE | 31 | 17 |
| At least one Grade 3 related unsolicited AE | 0 | 1 |
| At least one medically attended unsolicited AE(s) | 64 | 53 |
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one SAE = at least one SAE regardless of relation to study vaccination. At least one related SAE = at least one SAE assessed by the investigator as related to the study vaccination.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| At least one SAE | 32 | 36 |
| At least one related SAE | 0 | 1 |
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one SAE = at least one SAE regardless of relation to study vaccination. At least one related SAE = at least one SAE assessed by the investigator as related to the study vaccination.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| At least one SAE | 88 | 93 |
| At least one related SAE | 0 | 1 |
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one related SAE = at least one SAE assessed by the investigator as related to the study vaccination.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| Number of Participants With at Least One Related SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years) | 0 | 1 |
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. SAEs related to study participation (and not to the study vaccine) or to GSK concomitant medication/vaccine were assessed.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| Number of Participants With at Least One SAE Related to Study Participation or to GlaxoSmithKline Concomitant Medication/Vaccine | 0 | 0 |
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one fatal SAE = at least one fatal SAE regardless of relation to study vaccination. At least one related fatal SAE = at least one fatal SAE assessed by the investigator as related to the study vaccination.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| At least one fatal SAE | 3 | 2 |
| At least one related fatal SAE | 0 | 0 |
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one fatal SAE = at least one fatal SAE regardless of relation to study vaccination. At least one related fatal SAE = at least one fatal SAE assessed by the investigator as related to the study vaccination.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| At least one fatal SAE | 11 | 9 |
| At least one related fatal SAE | 0 | 0 |
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 resulted in abnormal pregnancy outcomes, or was considered medically significant. At least one related fatal SAE = at least one fatal SAE assessed by the investigator as related to the study vaccination.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| Number of Participants With at Least One Related Fatal SAE From First Vaccination (Day 1) up to Study End (Duration of Approximately 2 Years) | 0 | 0 |
pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. At least one pIMD = at least one pIMD regardless of relation to vaccination. At least one related pIMD = at least one pIMD assessed by the investigator as related to the study vaccination.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| At least one pIMD | 2 | 2 |
| At least one related pIMD | 0 | 0 |
pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. At least one pIMD = at least one pIMD regardless of relation to study vaccination. At least one related pIMD = at least one related pIMD assessed by the investigator as related to the study vaccination.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| At least one pIMD | 2 | 3 |
| At least one related pIMD | 0 | 0 |
pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. At least one related serious pIMD = at least one serious pIMD assessed by the investigator as related to the study vaccination.
| Participants | RZV Group | Placebo Group |
|---|---|---|
| Number of Participants With at Least One Related Serious pIMD From 12 Months Post Last Vaccination up to Study End (Duration of Approximately 1 Year) | 0 | 0 |
Collected over Solicited local and general AEs: during the 7-day (Day 1 to Day 7) follow-up period after any vaccination; Unsolicited AEs: during the 30-day (Day 1 to Day 30) follow-up period after any vaccination; All-cause mortality and SAEs: from first vaccination (Day 1) up to study end (duration of approximately 2 years).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RZV Group | 13/3,064 (0.4%) | 90/3,064 (2.9%) | 2,337/3,064 (76.3%) |
| Placebo Group | 11/3,064 (0.4%) | 94/3,064 (3.1%) | 485/3,064 (15.8%) |
| Event | RZV Group | Placebo Group |
|---|---|---|
| Cerebral infarctionNervous system disorders | 24/3064 | 18/3064 |
| Arteriosclerosis coronary arteryCardiac disorders | 8/3064 | 4/3064 |
| HypertensionVascular disorders | 8/3064 | 4/3064 |
| PneumoniaInfections and infestations | 5/3064 | 6/3064 |
| Chronic gastritisGastrointestinal disorders | 4/3064 | 3/3064 |
| Rib fractureInjury, poisoning and procedural complications | 4/3064 | 3/3064 |
| Spinal osteoarthritisMusculoskeletal and connective tissue disorders | 1/3064 | 4/3064 |
| Angina unstableCardiac disorders | 3/3064 | 1/3064 |
| Atrial fibrillationCardiac disorders | 3/3064 | 1/3064 |
| Cardiac failureCardiac disorders | 3/3064 | 1/3064 |
| Event | RZV Group | Placebo Group |
|---|---|---|
| Administration site painGeneral disorders | 2203/3064 | 280/3064 |
| FatigueGeneral disorders | 1326/3064 | 161/3064 |
| HeadacheNervous system disorders | 1001/3064 | 94/3064 |
| Administration site swellingGeneral disorders | 855/3064 | 24/3064 |
| MyalgiaMusculoskeletal and connective tissue disorders | 811/3064 | 71/3064 |
| Administration site erythemaGeneral disorders | 762/3064 | 21/3064 |
| ChillsGeneral disorders | 544/3064 | 14/3064 |
| PyrexiaGeneral disorders | 457/3064 | 21/3064 |
| Gastrointestinal disorder (Gastrointestinal disorders | 444/3064 | 67/3064 |
| DizzinessNervous system disorders | 25/3064 | 9/3064 |
| Age, Continuous(Years) | RZV Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 62.4 ± 7.8 | 62.4 ± 7.8 | 62.4 ± 7.8 |
| Sex: Female, Male(Participants) | RZV Group | Placebo Group | Total |
|---|---|---|---|
| Female | 1868 | 1872 | 3740 |
| Male | 1196 | 1192 | 2388 |
| Race/Ethnicity, Customized(Participants) | RZV Group | Placebo Group | Total |
|---|---|---|---|
| Asian - East Asian Heritage | 3064 | 3064 | 6128 |
Documents are hosted by the registry — open the source record to download them.
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, Sap, Icf, Csr
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
GlaxoSmithKline