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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
288
GSK Investigational Site
Visakhapatnam, Andhra Pradesh, India
GSK Investigational Site
North Guwāhāti, Assam, India
GSK Investigational Site
Ahmedabad, Gujarat, India
GSK Investigational Site
Mumbai, Maharashtra, India
Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE)
A participant with vaccine response for anti-gE was defined as a participant with: * at least a 4-fold greater post-last vaccination anti-gE antibody (Ab) concentration as compared to the pre-vaccination anti-gE Ab concentration, for participants who were seropositive at baseline, or * at least a 4-fold greater post-last vaccination anti-gE Ab concentration as compared to the anti-gE Ab cut-off value for seropositivity, for participants who were seronegative at baseline.
Time frame: At 1 month post-Dose 2 of study intervention administration (Month 3)
Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) and Between-group GMC Ratios
Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as GMCs in milli-international units per milliliter (mIU/mL).
Time frame: At 1 month post-Dose 2 of study intervention administration (Month 3)
Percentage of Participants Reporting Solicited Administration Site Events
The assessed solicited administration site events included injection site erythema, pain, pruritus and swelling.
Time frame: Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2)
Percentage of Participants Reporting Solicited Systemic Events
The assessed solicited systemic events included fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and shivering.
Time frame: Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2)
Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as an AE that was not included in a list of solicited events using a participant diary. Unsolicited events must have been spontaneously communicated by a participant who had signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
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GSK Investigational Site
Chandigarh, Punjab, India
GSK Investigational Site
Kanpur, India
GSK Investigational Site
Mysore, India
GSK Investigational Site
New Delhi, India
GSK Investigational Site
Pune, India
Time frame: Within 30 days after any study intervention dose administration (vaccine/placebo administered at Day 1 and Month 2)
Percentage of Participants Reporting Serious Adverse Events (SAEs)
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes.
Time frame: From Dose 1 (Day 1) up to 30 days post-last study intervention dose
Percentage of Participants Reporting Potential Immune-mediated Diseases (pIMDs)
pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Time frame: From Dose 1 (Day 1) up to 30 days post-last study intervention dose
Percentage of Participants Reporting SAEs
An SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant or an abnormal pregnancy outcome, or an important medical event that may not have been life-threatening or resulted in death or hospitalization, but may have jeopardized the participant or required medical or surgical intervention to prevent one of the aforementioned outcomes.
Time frame: From Dose 1 (Day 1) up to study end (Month 8)
Percentage of Participants Reporting pIMDs
pIMDs were defined as a subset of AEs of special interest that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology.
Time frame: From Dose 1 (Day 1) up to study end (Month 8)
Anti-gE Antibody Concentrations Expressed as GMCs
Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.
Time frame: At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3)
Percentage of Participants Seropositive for Anti-gE Antibodies
A participant seropositive for anti-gE antibodies was defined as a participant whose antibody concentration was greater than or equal to (\>=) the assay cut-off value (97 mIU/mL).
Time frame: At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3)
Mean Geometric Increase (MGI) of Anti-gE Antibody Concentrations
MGI was defined as the geometric mean of the within participant ratios of anti-gE antibody concentration at 1 month post-Dose 2 (Month 3) compared to pre-study intervention administration (Day 1) anti-gE antibody concentration.
Time frame: At 1 month post-Dose 2 of study intervention administration (Month 3) compared to pre-study intervention administration (Day 1)