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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RZV Group | Experimental | Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2. |
|
| Placebo Group | Placebo Comparator | Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RZV | Biological | 2 doses of RZV in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
Written or witnessed/thumb printed informed consent obtained from the participant/participant's LAR prior to performance of any study specific procedure.
A male or female aged 50 years or older at the time of the first vaccination.
Medically stable participants as established by medical history and history-directed clinical examination before entering into the study.
Female participants 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 or post-menopause.
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
• 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.
Other exclusions
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Huaian | Jiangsu | 223005 | China | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38838170 | Background | Alexandra Echeverria Proano D, Zhu F, Sun X, Zoco J, Soni J, Parmar N, Ali SO; Zoster-076 Study Group. Efficacy, reactogenicity, and safety of the adjuvanted recombinant zoster vaccine for the prevention of herpes zoster in Chinese adults >/= 50 years: A randomized, placebo-controlled trial. Hum Vaccin Immunother. 2024 Dec 31;20(1):2351584. doi: 10.1080/21645515.2024.2351584. Epub 2024 Jun 5. | |
| 37781954 |
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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
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
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.
A total of 6138 participants were enrolled into the study, of which 6128 participants received at least 1 dose of study treatment/vaccine (RZV or placebo) and were included in the Exposed Set.
The study was conducted at 6 centers in China.
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| ID | Title | Description |
|---|---|---|
| FG000 | RZV Group | Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2. |
| FG001 | Placebo Group | Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | RZV Group | Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2. |
| BG001 | Placebo Group | Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The analysis was performed on the modified Exposed Set, which excluded participants from the Exposed Set who were not administered 2 doses of the study vaccine, or who developed a confirmed case of HZ prior to 30 days after the second vaccination. | Posted | Number | Cases per 1000 person-years | From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years) |
|
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).
The adverse events reported in the Other Adverse Events module were assessed based on GSK's standard grading scale.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RZV Group | Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | v26.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | v26.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 23, 2020 | Apr 17, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2023 | Apr 17, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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This study was conducted in an observer-blind manner. This means that during the course of the study, the vaccine(s) recipient and those responsible for the evaluation of any study endpoint were all unaware of which study intervention was administered. The laboratory in charge of the laboratory testing was blinded to the treatment, and codes were used to link the participant and study (without any link to the treatment attributed to the participant) to each sample.
| Placebo | Drug | 2 doses of placebo in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) |
| Lianyungang |
| 222100 |
| China |
| GSK Investigational Site | Shanghai | 200001 | China |
| GSK Investigational Site | Shanghai | 200051 | China |
| GSK Investigational Site | Shanghai | 200090 | China |
| GSK Investigational Site | Shanghai | 201620 | China |
| Derived |
| de 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. |
| Adverse event requiring expedited reporting |
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| Unsolicited non-serious adverse event |
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| Solicited adverse event |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG000 |
| RZV Group |
Participants randomized to the RZV Group were scheduled to receive two doses of RZV, one at Day 1 and one at Month 2. |
| OG001 | Placebo Group | Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2. |
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| Secondary | 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). | The analysis was performed on the modified Exposed Set, which excluded participants from the Exposed Set who were not administered 2 doses of the study vaccine, or who developed a confirmed case of HZ prior to 30 days after the second vaccination. | Posted | Number | Cases per 1000 person-years | From Month 3 (30 days after the second vaccination) up to study end (duration of approximately 2 years) |
|
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|
| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment and who have documented solicited AEs after each vaccination (i.e. diary card for solicited AEs completed and returned). | Posted | Count of Participants | Participants | Within 7 days after each vaccination (occurring at Day 1 and Month 2) |
|
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| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment and who have documented solicited AEs after each vaccination (i.e. diary card for solicited AEs completed and returned). | Posted | Count of Participants | Participants | Within 7 days after each vaccination (occurring at Day 1 and Month 2) |
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| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | Within 30 days after any vaccination (occurring at Day 1 and Month 2) |
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| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | 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) |
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| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | From first vaccination (Day 1) up to study end (duration of approximately 2 years) |
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| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | From the time the participant consented to participate in the study (Day 1) up to study end (duration of approximately 2 years) |
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| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | 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) |
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|
|
| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | 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) |
|
|
|
| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | From first vaccination (Day 1) up to study end (duration of approximately 2 years) |
|
|
|
| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | 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) |
|
|
|
| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | 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) |
|
|
|
| Secondary | 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. | The analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study treatment. | Posted | Count of Participants | Participants | 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) |
|
|
|
| 13 |
| 3,064 |
| 90 |
| 3,064 |
| 2,337 |
| 3,064 |
| EG001 | Placebo Group | Participants randomized to the Placebo Group were scheduled to receive two doses of placebo, one at Day 1 and one at Month 2. | 11 | 3,064 | 94 | 3,064 | 485 | 3,064 |
| Acute myocardial infarction | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Angina unstable | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Arrhythmia | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Arteriosclerosis coronary artery | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Cardiac disorder | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Cardiac dysfunction | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Coronary artery insufficiency | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Defect conduction intraventricular | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Left ventricular failure | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | v26.0 | Systematic Assessment |
|
| Oesophageal cyst | Congenital, familial and genetic disorders | v26.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | v26.0 | Systematic Assessment |
|
| Thyroid mass | Endocrine disorders | v26.0 | Systematic Assessment |
|
| Thyroiditis subacute | Endocrine disorders | v26.0 | Systematic Assessment |
|
| Cataract | Eye disorders | v26.0 | Systematic Assessment |
|
| Diabetic blindness | Eye disorders | v26.0 | Systematic Assessment |
|
| Glaucoma | Eye disorders | v26.0 | Systematic Assessment |
|
| Pterygium | Eye disorders | v26.0 | Systematic Assessment |
|
| Refraction disorder | Eye disorders | v26.0 | Systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | v26.0 | Systematic Assessment |
|
| Abdominal hernia | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Abdominal mass | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Gastrointestinal perforation | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Haemoperitoneum | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Haemorrhagic erosive gastritis | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Intestinal obstruction | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Peritoneal perforation | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | v26.0 | Systematic Assessment |
|
| Sudden death | General disorders | v26.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | v26.0 | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | v26.0 | Systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | v26.0 | Systematic Assessment |
|
| Haemophagocytic lymphohistiocytosis | Immune system disorders | v26.0 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | v26.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | v26.0 | Systematic Assessment |
|
| Cholecystitis infective | Infections and infestations | v26.0 | Systematic Assessment |
|
| Erysipelas | Infections and infestations | v26.0 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | v26.0 | Systematic Assessment |
|
| Infection | Infections and infestations | v26.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | v26.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | v26.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | v26.0 | Systematic Assessment |
|
| Acetabulum fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Brain contusion | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Brain herniation | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Cervical vertebral fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Electrical burn | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Epidural haemorrhage | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Facial bones fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Jaw fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Limb crushing injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Limb fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Patella fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Pleural injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Scapula fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Spinal cord injury cervical | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Subdural haemorrhage | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Tibia fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Ulna fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Diabetic complication | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Synovial cyst | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Benign lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Brain neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Lipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Lung squamous cell carcinoma stage III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Squamous cell carcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Tongue neoplasm malignant stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Basal ganglia haemorrhage | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Cerebral thrombosis | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Facial paralysis | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Hemiplegia | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Intraventricular haemorrhage | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Lacunar infarction | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Quadriplegia | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Vertebrobasilar insufficiency | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Completed suicide | Psychiatric disorders | v26.0 | Systematic Assessment |
|
| Conversion disorder | Psychiatric disorders | v26.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | v26.0 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | v26.0 | Systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | v26.0 | Systematic Assessment |
|
| Renal cyst | Renal and urinary disorders | v26.0 | Systematic Assessment |
|
| Ureterolithiasis | Renal and urinary disorders | v26.0 | Systematic Assessment |
|
| Urethral prolapse | Renal and urinary disorders | v26.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | v26.0 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | v26.0 | Systematic Assessment |
|
| Uterovaginal prolapse | Reproductive system and breast disorders | v26.0 | Systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Pharyngeal cyst | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Diabetic vascular disorder | Vascular disorders | v26.0 | Systematic Assessment |
|
| Essential hypertension | Vascular disorders | v26.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | v26.0 | Systematic Assessment |
|
| Scalp haematoma | Vascular disorders | v26.0 | Systematic Assessment |
|
| Varicose vein | Vascular disorders | v26.0 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | v26.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | v26.0 | Systematic Assessment |
|
| Porencephaly | Congenital, familial and genetic disorders | v26.0 | Systematic Assessment |
|
| Deafness bilateral | Ear and labyrinth disorders | v26.0 | Systematic Assessment |
|
| Thyroiditis subacute | Endocrine disorders | v26.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Chronic gastritis | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Gastrointestinal disorder ( | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Gingival swelling | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | v26.0 | Systematic Assessment |
|
| Administration site erythema | General disorders | v26.0 | Systematic Assessment |
|
| Administration site pain | General disorders | v26.0 | Systematic Assessment |
|
| Administration site swelling | General disorders | v26.0 | Systematic Assessment |
|
| Axillary pain | General disorders | v26.0 | Systematic Assessment |
|
| Chest discomfort | General disorders | v26.0 | Systematic Assessment |
|
| Chills | General disorders | v26.0 | Systematic Assessment |
|
| Fatigue | General disorders | v26.0 | Systematic Assessment |
|
| Injection site haematoma | General disorders | v26.0 | Systematic Assessment |
|
| Injection site pain | General disorders | v26.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | v26.0 | Systematic Assessment |
|
| Pain | General disorders | v26.0 | Systematic Assessment |
|
| Peripheral swelling | General disorders | v26.0 | Systematic Assessment |
|
| Pyrexia | General disorders | v26.0 | Systematic Assessment |
|
| Thirst | General disorders | v26.0 | Systematic Assessment |
|
| Vaccination site induration | General disorders | v26.0 | Systematic Assessment |
|
| Vaccination site pain | General disorders | v26.0 | Systematic Assessment |
|
| Vaccination site pruritus | General disorders | v26.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | v26.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | v26.0 | Systematic Assessment |
|
| Cystitis | Infections and infestations | v26.0 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | v26.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | v26.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | v26.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | v26.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | v26.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | v26.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | v26.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | v26.0 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Soft tissue injury | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | v26.0 | Systematic Assessment |
|
| Blood uric acid increased | Investigations | v26.0 | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | v26.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | v26.0 | Systematic Assessment |
|
| Intracranial haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | v26.0 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Cerebrovascular insufficiency | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Paralysis | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Post herpetic neuralgia | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Tension headache | Nervous system disorders | v26.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | v26.0 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | v26.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | v26.0 | Systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | v26.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | v26.0 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | v26.0 | Systematic Assessment |
|
| Essential hypertension | Vascular disorders | v26.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | v26.0 | Systematic Assessment |
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| Vascular rupture | Vascular disorders | v26.0 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| >=70 YOA |
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| At least Grade 3 Erythema, post-vaccination at Day 1 |
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| Medically attended visit Erythema, post-vaccination at Day 1 |
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| Any Pain, post-vaccination at Day 1 |
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| At least Grade 3 Pain, post-vaccination at Day 1 |
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| Medically attended visit Pain, post-vaccination at Day 1 |
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| Any Swelling, post-vaccination at Day 1 |
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| At least Grade 3 Swelling, post-vaccination at Day 1 |
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| Medically attended visit Swelling, post-vaccination at Day 1 |
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| Any Erythema, post-vaccination at Month 2 |
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| At least Grade 3 Erythema, post-vaccination at Month 2 |
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| Medically attended visit Erythema, post-vaccination at Month 2 |
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| Any Pain, post-vaccination at Month 2 |
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| At least Grade 3 Pain, post-vaccination at Month 2 |
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| Medically attended visit Pain, post-vaccination at Month 2 |
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| Any Swelling, post-vaccination at Month 2 |
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| At least Grade 3 Swelling, post-vaccination at Month 2 |
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| Medically attended visit Swelling, post-vaccination at Month 2 |
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| At least Grade 3 Fatigue, post-vaccination at Day 1 |
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| Related Fatigue, post-vaccination at Day 1 |
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| Medically attended visit Fatigue, post-vaccination at Day 1 |
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| Any Fever, post-vaccination at Day 1 |
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| At least Grade 3 Fever, post-vaccination at Day 1 |
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| Related Fever, post-vaccination at Day 1 |
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| Medically attended visit Fever, post-vaccination at Day 1 |
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| Any Gastrointestinal symptoms, post-vaccination at Day 1 |
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| At least Grade 3 Gastrointestinal symptoms, post-vaccination at Day 1 |
|
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| Related Gastrointestinal symptoms, post-vaccination at Day 1 |
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| Medically attended visit Gastrointestinal symptoms, post-vaccination at Day 1 |
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| Any Headache, post-vaccination at Day 1 |
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| At least Grade 3 Headache, post-vaccination at Day 1 |
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| Related Headache, post-vaccination at Day 1 |
|
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| Medically attended visit Headache, post-vaccination at Day 1 |
|
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| Any Myalgia, post-vaccination at Day 1 |
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| At least Grade 3 Myalgia, post-vaccination at Day 1 |
|
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| Related Myalgia, post-vaccination at Day 1 |
|
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| Medically attended visit Myalgia, post-vaccination at Day 1 |
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| Any Shivering, post-vaccination at Day 1 |
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| At least Grade 3 Shivering, post-vaccination at Day 1 |
|
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| Related Shivering, post-vaccination at Day 1 |
|
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| Medically attended visit Shivering, post-vaccination at Day 1 |
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| Any Fatigue, post-vaccination at Month 2 |
|
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| At least Grade 3 Fatigue, post-vaccination at Month 2 |
|
|
| Related Fatigue, post-vaccination at Month 2 |
|
|
| Medically attended visit Fatigue, post-vaccination at Month 2 |
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| Any Fever, post-vaccination at Month 2 |
|
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| At least Grade 3 Fever, post-vaccination at Month 2 |
|
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| Related Fever, post-vaccination at Month 2 |
|
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| Medically attended visit Fever, post-vaccination at Month 2 |
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| Any Gastrointestinal symptoms, post-vaccination at Month 2 |
|
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| At least Grade 3 Gastrointestinal symptoms, post-vaccination at Month 2 |
|
|
| Related Gastrointestinal symptoms, post-vaccination at Month 2 |
|
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| Medically attended visit Gastrointestinal symptoms, post-vaccination at Month 2 |
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| Any Headache, post-vaccination at Month 2 |
|
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| At least Grade 3 Headache, post-vaccination at Month 2 |
|
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| Related Headache, post-vaccination at Month 2 |
|
|
| Medically attended visit Headache, post-vaccination at Month 2 |
|
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| Any Myalgia, post-vaccination at Month 2 |
|
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| At least Grade 3 Myalgia, post-vaccination at Month 2 |
|
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| Related Myalgia, post-vaccination at Month 2 |
|
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| Medically attended visit Myalgia, post-vaccination at Month 2 |
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| Any Shivering, post-vaccination at Month 2 |
|
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| At least Grade 3 Shivering, post-vaccination at Month 2 |
|
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| Related Shivering, post-vaccination at Month 2 |
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| Medically attended visit Shivering, post-vaccination at Month 2 |
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| At least one related unsolicited AE |
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| At least one Grade 3 related unsolicited AE |
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| At least one medically attended unsolicited AE(s) |
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