A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Ye… (NCT05219253) | Clinical Trial Compass
CompletedPhase 3
A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India
India288 participantsStarted 2022-02-02
Plain-language summary
The purpose of this study was to evaluate the humoral immunogenicity and safety of 2 doses of GSK Biologicals' Herpes Zoster subunit vaccine (HZ/su) administered for the prevention of Herpes Zoster (HZ) in adults aged 50 years of age (YOA) or older from India.
Who can participate
Age range50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants and/or participant's legally acceptable representative(s) (LAR) 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 and/or participant's LAR(s) after the study has been explained according to local regulatory requirements and prior to performance of any study-specific procedure.
* A male or female aged 50 YOA or older at the time of the first study intervention.
* Healthy participants or medically stable patients as established by medical history and clinical examination before entering into the study.
* Female participants of non-childbearing potential may be enrolled in the study.
* Female participants of childbearing potential may be enrolled in the study, if the participant:
* has practiced adequate contraception for 1 month prior to study intervention administration, and
* has a negative pregnancy test on the day of study intervention administration, and
* has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the study intervention administration series.
Exclusion Criteria:
Medical conditions
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of t…
What they're measuring
1
Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE)
Timeframe: At 1 month post-Dose 2 of study intervention administration (Month 3)