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The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in healthy ethnic Japanese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herpes Zoster Vaccine GSK 1437173A | Biological | Investigational vaccine (GSK 1437173A) administered intramuscularly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited local and general symptoms | Day 0-6 after each vaccination | |
| Unsolicited adverse events | Day 0 -29 | |
| Serious adverse events | From dose 1 up to the end of the study | |
| Occurrence of pre-defined adverse events | From dose 1 up to study end | |
| Haematological and biochemical parameters | Months 0, 1 and 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Antigen and virus-specific antibody concentrations at protocol-defined time points | Months 0, 1 and 3 |
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Inclusion Criteria:
Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
A male or female between, and including, 18 and 30 years of age at the time of the first vaccination for inclusion in the young adults cohort or aged between, and including, 50 and 69 years of age at the time of the first vaccination for inclusion in the older adults cohort.
Written informed consent obtained from the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Japanese ethnic origin (defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese).
Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Male subjects may be enrolled in the study, if the subject:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Randwick | New South Wales | 2031 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23584252 | Derived | Lal H, Zahaf T, Heineman TC. Safety and immunogenicity of an AS01-adjuvanted varicella zoster virus subunit candidate vaccine (HZ/su): a phase-I, open-label study in Japanese adults. Hum Vaccin Immunother. 2013 Jul;9(7):1425-9. doi: 10.4161/hv.24269. Epub 2013 Apr 12. |
| Label | URL |
|---|---|
| Results for study 113819 can be found on the GSK Clinical Study Register | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113819 | Informed Consent Form | 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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| 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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For additional information about this study please refer to the GSK Clinical Study Register |
| 113819 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113819 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113819 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113819 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113819 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113819 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| D007239 | Infections |