Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers
This study is currently recruiting participants.
Verified May 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01767467
First received: January 10, 2013
Last updated: May 9, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Herpes Zoster Vaccine |
Biological: Herpes zoster vaccine (GSK 1437173A) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Occurrence of solicited local and general symptoms [ Time Frame: Up to 7 days (Days 0-6) after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of unsolicited adverse events (AEs) [ Time Frame: Up to 30 days (Days 0-29) after each vaccination ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events (SAEs) [ Time Frame: Up to 30 days post last vaccination ] [ Designated as safety issue: No ]
- Occurrence of AEs of specific interest [ Time Frame: Up to 30 days post last vaccination ] [ Designated as safety issue: No ]
- Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia [ Time Frame: At Month 2 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Occurrence of serious adverse events (SAEs) [ Time Frame: From first vaccination up to 6 months post last vaccination ] [ Designated as safety issue: No ]
- Occurrence of SAEs [ Time Frame: From 30 days post last vaccination until study end ] [ Designated as safety issue: No ]
- Occurrence of AEs of specific interest [ Time Frame: From first vaccination up to 6 months post last vaccination ] [ Designated as safety issue: No ]
- Occurrence of AEs of specific interest [ Time Frame: From 30 days post last vaccination until study end ] [ Designated as safety issue: No ]
- Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma [ Time Frame: At Month 2 ] [ Designated as safety issue: No ]
- Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia [ Time Frame: At Month 2 ] [ Designated as safety issue: No ]
- Occurrence of confirmed HZ cases [ Time Frame: From Month 0 until study end ] [ Designated as safety issue: No ]
- Anti-gE humoral immunogenicity in all vaccinated subjects [ Time Frame: At Month 0, Month 1, Month 2 and Month 13 ] [ Designated as safety issue: No ]
- Anti-gE humoral immunogenicity in all vaccinated subjects [ Time Frame: At Month 1, Month 2 and Month 13 ] [ Designated as safety issue: No ]
- gE-specific CD4+ T-cell-mediated immunogenicity response in the CMI sub-cohort [ Time Frame: At Month 0, Month 1, Month 2 and Month 13 ] [ Designated as safety issue: No ]
- gE-specific CD4+ T-cell-mediated immunogenicity response in the CMI sub-cohort [ Time Frame: At Month 1, Month 2 and Month 13 ] [ Designated as safety issue: No ]
- Anti-gE humoral immunogenicity in subjects with confirmed HZ and matched controls [ Time Frame: At Month 0 and at Month 2 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 502 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vaccine Group
Subjects will receive the candidate HZ vaccine (GSK 1437173A).
|
Biological: Herpes zoster vaccine (GSK 1437173A)
2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.
|
|
Placebo Comparator: Placebo Group
Subjects will receive the placebo vaccine.
|
Drug: Placebo
2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- A male or female, aged 18 years or older at the time of study entry.
- Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition.
- Life expectancy greater than or equal to 12 months, as assessed by the investigator.
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 inthe study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled).
- Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy.
- Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT occurred prior to enrolment in the study, the subject may not receive study vaccine until at least 50 days after the transplant procedure).
- Human immunodeficiency virus (HIV) infection by clinical history.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject's underlying disease, is allowed.
- Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
- Planned administration during the study of a HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
- Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine.
- Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months after the last dose of study vaccine/placebo).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01767467
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| Belgium | |
| GSK Investigational Site | Recruiting |
| Antwerpen, Belgium, 2060 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Bruxelles, Belgium, 1000 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Hasselt, Belgium, 3500 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Canada, Nova Scotia | |
| GSK Investigational Site | Not yet recruiting |
| Halifax, Nova Scotia, Canada, B3K 6R8 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Canada, Ontario | |
| GSK Investigational Site | Not yet recruiting |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Finland | |
| GSK Investigational Site | Not yet recruiting |
| Helsinki, Finland, 00029 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Tampere, Finland, 33520 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| France | |
| GSK Investigational Site | Not yet recruiting |
| Mulhouse, France, 68070 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Nantes cedex 1, France, 44093 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Pessac cedex, France, 33604 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Italy | |
| GSK Investigational Site | Not yet recruiting |
| Meldola (FC), Emilia-Romagna, Italy, 47014 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Udine, Friuli-Venezia-Giulia, Italy, 33100 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Novara, Piemonte, Italy, 28100 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Korea, Republic of | |
| GSK Investigational Site | Not yet recruiting |
| Jellanamdo, Korea, Republic of, 519-809 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Jeonju, Korea, Republic of, 561-712 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Spain | |
| GSK Investigational Site | Not yet recruiting |
| Madrid, Spain, 28050 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Majadahonda (Madrid), Spain, 28222 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Pozuelo de Alarcón/Madrid, Spain, 28223 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Santander, Spain, 39008 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| Sweden | |
| GSK Investigational Site | Recruiting |
| Karlskrona, Sweden, SE-371 41 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Malmö, Sweden, SE-205 02 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Uppsala, Sweden, SE-751 85 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| United Kingdom | |
| GSK Investigational Site | Recruiting |
| Orpington, Kent, United Kingdom, BR6 8ND | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Airdrie, Lanarkshire, United Kingdom, ML6 0JS | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| Swindon, Wiltshire, United Kingdom, SN3 6BB | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Not yet recruiting |
| Bournemouth, United Kingdom, BH7 7DW | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| GSK Investigational Site | Recruiting |
| London, United Kingdom, SE13 6LH | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01767467 History of Changes |
| Other Study ID Numbers: | 116428, 2012-003438-18 |
| Study First Received: | January 10, 2013 |
| Last Updated: | May 9, 2013 |
| Health Authority: | New Zealand: Medsafe France: Agence nationale de sécurité du médicament et des produits de santé (ANSM) Russia: Ministry of Health of Russian Federation Spain: Agencia Española del Medicamento y Productos Sanitarios Finland: The Finnish Medicines Agency (FIMEA) Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Taiwan: Taiwan Food and Drug Administration (TFDA) Singapore: Health Sciences Authority United States: Food and Drug Administration India: Drugs Controller General of India South Korea: Korea Food and Drug Administration (KFDA) United Kingdom: Medicines and Healthcare Products Regulatory Agency Hong Kong: Department of Health Brazil: ANVISA - Agência Nacional de Vigilância Sanitaria Belgium: Agence Federale des Medicaments et des produits de sante Australia: Therapeutics Goods Administration (TGA) Pakistan: Drug Regulatory Authority of Pakistan (DRAP) Italy: Comitato Etico di Area Vasta Romagna e I.R.S.T. Sweden: Medical Products Agency Czech: State Institute for Drug Control Canada: Health Canada Poland: Drug Institute for Registration of Medicinal Products Turkey: Ministry of Health |
Keywords provided by GlaxoSmithKline:
|
Immunogenicity Safety Herpes zoster Vaccination Haematologic malignancies |
Additional relevant MeSH terms:
|
Herpes Zoster Hematologic Neoplasms Herpesviridae Infections DNA Virus Infections |
Virus Diseases Neoplasms by Site Neoplasms Hematologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013