Immunogenicity and safety study of GSK Biologicals’ herpes zoster vaccine with various formulations in adults >= 50 years
Trial overview
Frequency of gE-specific cluster of differentiation 4 (CD4+) T-cells expressing at least 2 different immunological activation markers
Timeframe: One month after the second vaccination (Month 3)
Frequency of Varicella-Zoster Virus (VZV)-specific CD4+ T-cells expressing at least 2 different immunological activation markers
Timeframe: One month after the second vaccination (Month 3)
Anti-glycoprotein E (gE) antibody concentrations
Timeframe: One month after the second vaccination (Month 3)
Anti-VZV antibody concentrations
Timeframe: One month after the second vaccination (Month 3)
Frequencies of gE-specific CD4+ T-cells expressing at least 2 different immunological activation markers
Timeframe: At Month 0 and at Month 2
Frequency of VZV-specific CD4+ T-cells expressing at least 2 different immunological activation markers
Timeframe: At Month 0 and at Month 2
Anti-gE antibody concentrations
Timeframe: At Month 0 and at Month 2
Anti-VZV antibody concentrations
Timeframe: At Month 0 and at Month 2
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
Number of subjects with any, Grade 3 and related solicited general symptoms.
Timeframe: During the 7-day (Days 0-6)post-vaccination period after each dose and across doses
Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)
Timeframe: Within the 30-day (Days 0-29) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: From Month 0 up to Month 8
Number of subjects with serious adverse events (SAEs)
Timeframe: During the period after Month 8 up to the end of the study at Month 14
Number of subjects with any new onset of autoimmune diseases (NOADs)
Timeframe: From Month 0 until Month 8
Number of subjects with any new onset of autoimmune diseases (NOADs)
Timeframe: During the period after Month 8 up to the end of the study at Month 14
Number of subjects with suspected cases of Herpes Zoster (HZ)
Timeframe: From Month 0 until Month 8
Number of subjects with suspected cases of Herpes Zoster (HZ)
Timeframe: During the period after Month 8 up to the end of the study at Month 14
Number of subjects with haematological and biochemical parameters unknown, below, within or above the normal ranges
Timeframe: At Month 0
Number of subjects with haematological and biochemical parameters unknown, below, within or above the normal ranges
Timeframe: At Month 2
Number of subjects with haematological and biochemical parameters unknown, below, within or above the normal ranges
Timeframe: At Month 3
Participation criteria
- A male or female 50 years of age or above at the time of the first vaccination;
- Written informed consent obtained from the subject;
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- Written informed consent obtained from the subject;
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
- If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
A male or female 50 years of age or above at the time of the first vaccination;
- Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
- Previous vaccination against HZ;
- Previous vaccination against varicella;
- History of HZ;
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;
- Acute disease at the time of enrolment.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
- History of or current drug and/or alcohol abuse;
- Pregnant or lactating female;
- Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.