A study on the immune response and safety of a vaccine against Herpes Zoster in adults aged 50 years and older in India
- Registration Number
- CTRI/2022/02/040060
- Lead Sponsor
- GlaxoSmithKline Biologicals SA GSK Rue de lInstitut Rixensart
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
All participants must satisfy ALL the following criteria at study entry
1 Participants and/or participants LAR who in
the opinion of the investigator can and will comply with the requirements of the
protocol (e.g. completion of the diary cards return for follow-up visits)
2 A male or female aged 50 YOA or older at the time of the first study intervention
3 Healthy participants or medically stable patients as established by medical history
and clinical examination before entering into the study
4 Female participants of non-childbearing potential may be enrolled in the study
5 Written or witnessed/thumb printed informed consent obtained from the participant
and/or participants LAR(s) after the study has been explained according to local
regulatory requirements and prior to performance of any study-specific procedure
6 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
The following criteria should be checked at the time of study entry. The potential
participant MAY NOT be included in the study if ANY exclusion criterion applies
1 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 the study intervention(s) or study materials or equipment.
• Acute or chronic clinically significant pulmonary cardiovascular hepatic or renal
functional abnormality, as determined by medical history, physical examination or
laboratory screening tests.
Any confirmed or suspected immunosuppressive or immunodeficient condition,
based on medical history and physical examination (no laboratory testing required).
• History of HZ.
• Significant underlying illness that in the opinion of the investigator would be
expected to prevent completion of the study (e.g. life-threatening disease likely to
limit survival to less than 4 years).
2 PRIOR CONCOMITANT THERAPY
Planned administration/administration of a vaccine not foreseen by the study
protocol in the period starting 30 days before first dose and ending 30 days after the
last dose of study intervention administration with the exception of licensed
pneumococcal vaccines and non-replicating vaccines (i.e. inactivated and subunit
vaccines including inactivated and subunit influenza vaccines, with or without
adjuvant for seasonal or pandemic flu) may be administered up until 8 days prior to
Dose 1 and/or Dose 2 and/or at least 14 days after any dose of study intervention.
• In case an emergency mass vaccination for an unforeseen public health threat (e.g. a
pandemic) is recommended and/or organized by the public health authorities, outside
the routine immunization programme, the time period described above can be
reduced if necessary for that vaccine provided it is used according to local
governmental recommendations and that the Sponsor is notified accordingly.
• Planned administration of long-acting immune-modifying drugs at any time during
the study period (e.g. infliximab).
• Administration of immunoglobulins and/or any blood products or plasma derivatives
during the period starting 3 months before the first dose of study intervention up to
1-month post-dose 2 (Month 3) or planned administration during the study period.
• 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 study intervention dose. For corticosteroids, this will mean
prednisone equivalent or greater than 20 mg/day or equivalent is not allowed. Inhaled
intra- articular and topical steroids are allowed.
• Previous vaccination against varicella or HZ.
3 PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE
Concurrently participating in another clinical study, at any time during the study period,
in which the participant has been or will be exposed to an investigational or a
non- investigational intervention (drug/invasive medical device).
4 OTHER EXC
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the vaccine response rate (VRR) for <br/ ><br>anti-gE humoral immune response at 1-month post dose <br/ ><br>2 (Month 3) of administration of HZ/suTimepoint: To determine the vaccine response rate (VRR) for <br/ ><br>anti-gE humoral immune response at 1-month post dose <br/ ><br>2 (Month 3) of administration of HZ/su
- Secondary Outcome Measures
Name Time Method