Month 30 & 42 extension studies of CRD-004 primary study
Trial overview
Frequencies of glycoprotein E (gE)-specific Cluster of Differentiation 4 (CD4) / CD8 T cells with at least two antigen-specific cytokines: Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor alpha (TNF-α), CD 40 ligand (CD40L).
Timeframe: At Month 30 after the first vaccination.
Frequencies of Varicella Zoster Virus (VZV)-specific CD4 / CD8 T cells with at least two antigen-specific cytokines (IFN-γ, IL-2, TNF-α, CD40L).
Timeframe: At Month 30 after the first vaccination
Frequencies of glycoprotein E (gE)-specific CD4 / CD8 T cells with at least two antigen-specific cytokines (IFN-γ, IL-2, TNF-α, CD40L).
Timeframe: At Month 42 after the first vaccination
Frequencies of Varicella Zoster Virus (VZV)-specific CD4 / CD8 T cells with at least two antigen-specific cytokines (IFN-γ, IL-2, TNF-α, CD40L).
Timeframe: At Month 42 after the first vaccination
Frequencies of gE- and VZV-specific CD4/CD8 T cells with antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L secretion/expression.
Timeframe: At Months 30 and 42 after the first vaccination
Anti-gE antibody (Ab) concentrations
Timeframe: At months 30 and 42 after the first vaccination
Anti-VZV Ab concentrations
Timeframe: At months 30 and 42 after the first vaccination
Frequencies of gE-specific memory B cells
Timeframe: At months 30 and 42 after the first vaccination
Frequencies of VZV-specific memory B cells
Timeframe: At months 30 and 42 after the first vaccination
Number of subjects with any Serious Adverse Events (SAEs)
Timeframe: From Month 30 to study end Month 42 after the first vaccination
Number of subjects with clinically diagnosed Herpes Zoster (HZ) episodes
Timeframe: From last primary study visit (Month 12) to study end at Month 42 after the first vaccination.
Participation criteria
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
- Subjects who successfully completed the primary study and who did not receive Varilrix in the primary study;
- Use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period;
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed;
•Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study; •Subjects who successfully completed the primary study and who did not receive Varilrix in the primary study; •Written informed consent obtained from the subject; •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
•Use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period; •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed; •Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks before the first study procedure, with the exception of the Influenza vaccine, which can be administered 1 week preceding the first study procedure; •Previous vaccination against HZ, except the study vaccine administered in the primary study; •History of HZ (shingles); •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination; •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study procedure or planned administration during the study period.
Trial location(s)
Study documents
No study documents available.
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.