Status:
COMPLETED
Efficacy, Immunogenicity and Safety Study of GSKs Recombinant Zoster Vaccine Shingrix (GSK1437173A) in Chinese Adults Aged ≥50 Years
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Zoster
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 Zost...
Eligibility Criteria
Inclusion
- 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
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series
Exclusion
- Medical conditions
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
- History of HZ.
- Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study materials and equipment.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
- Prior/Concomitant therapy
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after the last dose of vaccine administration. However, licensed pneumococcal vaccines and inactivated and subunit influenza vaccines (without adjuvant for seasonal or pandemic flu) may be co- administered with any dose of study vaccine.
- Previous vaccination against varicella or HZ.
- Administration of long-acting immune-modifying drugs at any time during the study period.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study vaccine up to one month post dose 2 (Month 3).
- Planned or chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first vaccine. For corticosteroids, this will mean prednisone ≥20mg/day, or equivalent, is not allowed. Inhaled, intra-articular and topical steroids are allowed.
- 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
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months of last vaccination.
- History of current/chronic alcohol consumption and/or drug abuse.
Key Trial Info
Start Date :
May 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
6138 Patients enrolled
Trial Details
Trial ID
NCT04869982
Start Date
May 14 2021
End Date
April 20 2023
Last Update
January 20 2025
Active Locations (6)
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1
GSK Investigational Site
Huaian, Jiangsu, China, 223005
2
GSK Investigational Site
Lianyungang, China, 222100
3
GSK Investigational Site
Shanghai, China, 200001
4
GSK Investigational Site
Shanghai, China, 200051