Vitamin D Supplementation And Varicella Zoster Virus Vaccine Responsiveness In Older Long-Term Care...
ImmunosenescenceShinglesThis is an ancillary study to a randomized controlled trial of high dose vitamin D in older long-term care residents (NCT01102374). In this study, a subset of trial subjects will receive the zoster vaccine and the investigators will determine the immunological response to the vaccine in this older, frail population, as well as the association between vitamin D and immunological outcomes.
Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in...
Herpes ZosterShinglesThis study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine...
Herpes ZosterThis is a study to evaluate the safety and immunogenicity of V212 vaccine in adults with autoimmune disease, including participants with rheumatoid arthritis, psoriatic arthritis, psoriasis, inflammatory bowel disease, systemic lupus erythematosus, multiple sclerosis, and other similar diseases. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at approximately 28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 95% confidence interval of the geometric mean fold rise in vaccine recipients is >1.0.
Study of Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With...
Japanese EncephalitisVaricellaThe aim of the study is to investigate the memory immune response and the yearly persistence of the immunity against Japanese Encephalitis (JE) after vaccination with Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in participants previously vaccinated with JE-CV vaccine. Objectives: To describe JE immune status before and after JE-CV vaccination in subjects previously vaccinated with JE-CV vaccine To describe the immune status before and after JE-CV vaccination in JE-naïve control subjects. To describe the safety (in terms of solicited and unsolicited adverse events) of a single dose of JE-CV vaccine up to 6 months after the last vaccination. To describe all related serious adverse events (SAEs) and related deaths from 6 months to 5 years after vaccination in JE-CV-primed subjects.
A Study to Evaluate the Safety and Immunogenicity of Inactivated Varicella-Zoster Virus (VZV) Vaccine...
Herpes ZosterAn open-label, multicenter study to evaluate the safety and immunogenicity of inactivated VZV vaccine (V212) in participants with hematologic malignancies (HM) who are currently receiving anti-CD20 monoclonal antibodies. The primary hypothesis is that vaccination with V212 vaccine will elicit significant VZV-specific immune responses at ~28 days after vaccination 4. The statistical criterion for significance requires that the lower bound of the 2-sided 90% confidence interval of the geometric mean fold rise in immune response in V212 recipients is >1.0.
Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process...
Herpes ZosterShinglesThis study will determine whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.
Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)
Herpes ZosterPrimary objective: To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by glycoprotein Enzyme Linked ImmunoSorbent Assay [gpELISA]) from pre-vaccination to 4 weeks post-vaccination. Secondary objectives: To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency.
A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox)...
Herpes ZosterThe purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.
Immunogenicity & Safety Study of GSK Biologicals' 208136 Vaccine Formulated With New Measles and...
MeaslesVaricella2 moreThis study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator. A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.
Immunogenicity and Safety of a 1-dose Regimen of a Zoster Vaccine Versus Different 2-dose Regimens...
Prevention of : Herpes-ZosterPrimary objective: Immunogenicity To demonstrate that a second dose of ZOSTAVAX® elicits higher varicella-zoster virus (VZV) antibody titres than a first dose of ZOSTAVAX® whether given as a 0-1 month schedule or as a 0-3 month schedule in subjects ≥70 years of age as measured at 4 weeks post-vaccination Secondary objectives Immunogenicity To summarise the VZV antibody titres at 4 weeks post-vaccination after a 1-dose regimen and 4 weeks post-vaccination after each dose of each 2-doses regimen of ZOSTAVAX®. To compare the VZV antibody titres at 12 months after completion of a 1-dose regimen with the VZV antibody titres at 12 months after completion of each 2-doses regimen of ZOSTAVAX® To summarise the VZV antibody titres at 24 and 36 months after completion of a 1-dose regimen and at 24 and 36 months after completion of each 2-doses regimen of ZOSTAVAX®