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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005671-14 | EudraCT Number |
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The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of GSK Biologicals' Herpes Zoster (HZ) vaccine (GSK 1437173A) when administered subcutaneously (SC) as compared to intramuscularly (IM) to people 50 years of age and older.
There are 2 treatment groups in this study based upon the mode of vaccine administration.
The humoral immunogenicity (HI) will be measured in all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SC HZ/su Group | Experimental | Subjects will receive HZ/su vaccine administered SC on a 0,2-month schedule. |
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| IM HZ/su Group | Active Comparator | Subjects will receive HZ/su vaccine administered IM on a 0,2-month schedule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herpes zoster vaccine GSK1437173A | Biological | HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) | A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL. | Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3) |
| Anti-gE Antibody Concentrations | Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL. | Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3) |
| Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. | At two months after Dose 1 (M2) and one month after Dose 2 (M3) |
| Descriptive Statistics of Anti-gE Antibody Concentrations | Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay. | Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3) |
| Number of Subjects With Solicited Local Symptoms | The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL | A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value of 97 mIU/mL. | At Month 14 |
| Anti-gE Antibody Concentrations |
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Inclusion Criteria:
Subject who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Subject, residing in Japan, is of Japanese ethnic origin, defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese.
Subject has provided written informed consent.
Subject, male or female, who is 50 YOA or older at the time of the first vaccination.
Subject, if female, of non-childbearing potential may be enrolled in the study.
Subject, if female, of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Concurrently participating or planned participation 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 product.
Administration or planned administration of a live vaccine within 30 days prior to the first study vaccination through 30 days after the second study vaccination.
Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
Planned administration, during the study, of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
Administration of immunoglobulins and/or any blood products within the three (3) months preceding the first dose of study vaccine or planned administration during the study period.
Chronic administration (defined as >14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Administration or planned administration of long-acting immune-modifying drugs (e.g., infliximab) within six months prior to the first vaccine dose through the duration of the study period.
History of HZ.
Previous vaccination against HZ or varicella (registered or investigational product).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study.
Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
Acute disease and/or fever at the time of vaccination:
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) through Month 4 (i.e., 2 months after the second dose of study vaccine).
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Fukuoka | 812-0025 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37781954 | 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. | |
| 27936344 | Derived | Vink P, Shiramoto M, Ogawa M, Eda M, Douha M, Heineman T, Lal H. Safety and immunogenicity of a Herpes Zoster subunit vaccine in Japanese population aged >/=50 years when administered subcutaneously vs. intramuscularly. Hum Vaccin Immunother. 2017 Mar 4;13(3):574-578. doi: 10.1080/21645515.2016.1232787. Epub 2016 Dec 9. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 116760 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
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| ID | Title | Description |
|---|---|---|
| FG000 | SC GSK1437173A Group | Subjects received the GSK1437173A vaccine administered subcutaneously (SC) on a 0,2-month schedule. |
| FG001 | IM GSK1437173A Group | Subjects received the GSK1437173A vaccine administered intramuscularly (IM) on a 0,2-month schedule. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses |
| Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination. | During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses |
| Mean Number of Days With Local Symptoms | Days with solicited local symptoms were tabulated for the total vaccinated cohort. | During the 7 day (Days 0-6) post vaccination, after each dose (D) |
| Mean Number of Days With General Symptoms | Days with solicited general symptoms were tabulated for the total vaccinated cohort. | During the 7 day (Days 0-6) post vaccination, after each dose (D) |
| Number of Subjects With Potential Immune-Mediated Disorders (pIMDs) | Potential immune-mediated diseases (pIMDs) were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | From Month 0 to Month 3 |
| Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | Within 30 days (Days 0-29) post vaccination period |
| Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | From Month 0 to Month 3 |
Anti-gE antibody concentrations were expressed as geometric mean concnetrations (GMCs) and measured in mIU/mL. |
| At Month 14 |
| Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. | Twelve Months after Dose 2 (M14) |
| Number of Subjects With pIMDs | Potential immune-mediated diseases (pIMDs) were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | Up to Month 14 post vaccination period |
| Number of Subjects With SAEs | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | Up to Month 14 post vaccination period |
For additional information about this study please refer to the GSK Clinical Study Register |
| 116760 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116760 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116760 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116760 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116760 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 116760 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | SC GSK1437173A Group | Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule. |
| BG001 | IM GSK1437173A Group | Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number of Subjects With Anti-Glycoprotein E (Anti-gE) Antibody Concentrations Higher Than or Equal to (≥)18 Milli-international Units Per Milliliter (mIU/mL) | A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value, of 18 mIU/mL. | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3) |
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| Primary | Anti-gE Antibody Concentrations | Anti-gE antibody concentrations were expressed as geometric mean concentrations (GMCs) and measured in mIU/mL. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Before vaccination (PRE), two months after Dose 1 (M2) and one month after Dose 2 (M3) |
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| Primary | Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x18 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available. | Posted | Count of Participants | Participants | At two months after Dose 1 (M2) and one month after Dose 2 (M3) |
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| Primary | Descriptive Statistics of Anti-gE Antibody Concentrations | Anti-gE antibody concentrations were assessed by the Enzyme Lynked Immunosorbent Assay. | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who had met all eligibility criteria and for whom data concerning immunogenicity outcome measures were available. | Posted | Median | Standard Deviation | mIU/mL | Before vaccination (PRE), at two months after dose 1 (M2) and one month after Dose 2 (M3) |
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| Primary | Number of Subjects With Solicited Local Symptoms | The solicited local symptoms assessed were: Arm movement/range of motion of the vaccinated arm, Injection site pruritus, Pain, Redness, and Swelling. Any = occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest that prevented normal every day activities. Grade 3 Injection site pruritus = Significant pruritus that prevented normal every day activities. Grade 3 impairment of arm movement/range of motion = Significant impairment of arm movement/range of motion that prevented normal every day activities. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and who had their symptom sheet filled-in. | Posted | Count of Participants | Participants | During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses |
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| Primary | Number of Subjects With Solicited General Symptoms | Assessed solicited general symptoms were: Fatigue, Fever, Gastrointestinal (nausea, vomiting, diarrhea and/or abdominal pain), Headache, Myalgia, and Shivering. Fever = axillary temperature ≥37.5°C. Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Fever = axillary temperature higher than (>) 39.0°C. Related = general symptom assessed by the investigator as causally related to vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered and who had their symptom sheet filled-in. | Posted | Count of Participants | Participants | During the 7 day (Days 0-6) post vaccination, after each dose (D) and across doses |
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| Primary | Mean Number of Days With Local Symptoms | Days with solicited local symptoms were tabulated for the total vaccinated cohort. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered. | Posted | Mean | Inter-Quartile Range | Days | During the 7 day (Days 0-6) post vaccination, after each dose (D) |
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| Primary | Mean Number of Days With General Symptoms | Days with solicited general symptoms were tabulated for the total vaccinated cohort. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered. | Posted | Mean | Inter-Quartile Range | Days | During the 7 day (Days 0-6) post vaccination, after each dose (D) |
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| Primary | Number of Subjects With Potential Immune-Mediated Disorders (pIMDs) | Potential immune-mediated diseases (pIMDs) were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered. | Posted | Count of Participants | Participants | From Month 0 to Month 3 |
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| Primary | Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered. | Posted | Count of Participants | Participants | Within 30 days (Days 0-29) post vaccination period |
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| Primary | Number of Subjects With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered. | Posted | Count of Participants | Participants | From Month 0 to Month 3 |
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| Secondary | Number of Subjects With Anti-gE Antibody Concentrations ≥ 97 mIU/mL | A seropositive subject was defined as a subject whose anti-gE Ab concentration was greater than or equal to the assay cut-off value of 97 mIU/mL. | The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available. | Posted | Count of Participants | Participants | At Month 14 |
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| Secondary | Anti-gE Antibody Concentrations | Anti-gE antibody concentrations were expressed as geometric mean concnetrations (GMCs) and measured in mIU/mL. | The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 14 |
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| Secondary | Number of Subjects With Vaccine Response for Anti-gE Antibody Concentrations | Vaccine response was defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); for initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration. | The analysis was performed on the ATP cohort for persistence, which included all evaluable subjects for whom data concerning immunogenicity persistence outcome variables were available. | Posted | Count of Participants | Participants | Twelve Months after Dose 2 (M14) |
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| Secondary | Number of Subjects With pIMDs | Potential immune-mediated diseases (pIMDs) were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered. | Posted | Count of Participants | Participants | Up to Month 14 post vaccination period |
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| Secondary | Number of Subjects With SAEs | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one study vaccine administered. | Posted | Count of Participants | Participants | Up to Month 14 post vaccination period |
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Solicited symptoms: during the 7-day post-vaccination period; Unsolicited AEs: during the 30-day post-vaccination period; SAEs: up to Month 14 post vaccination.
No unsolicited AEs with a frequency over 5% were reported.
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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 | SC GSK1437173A Group | Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule. | 0 | 30 | 2 | 30 | 30 | 30 |
| EG001 | IM GSK1437173A Group | Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule. | 0 | 30 | 1 | 30 | 28 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Mallet finger | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm movement | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Redness | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Fever/(Axillary) | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Gastrointestinal symptoms | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Headache | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Myalgia (muscle aches) | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 18.0 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| Anti-gE, M3 |
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