Trial Outcomes & Findings for A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India (NCT NCT05219253)
NCT ID: NCT05219253
Last Updated: 2025-05-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
288 participants
Primary outcome timeframe
At 1 month post-Dose 2 of study intervention administration (Month 3)
Results posted on
2025-05-15
Participant Flow
The study was conducted at 9 centers in India.
All 288 participants enrolled in this study received 2 doses of the study interventions and were included in the Exposed Set. A total of 285 participants completed the study.
Participant milestones
| Measure |
HZ/suSeq Group
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Overall Study
STARTED
|
143
|
145
|
|
Overall Study
COMPLETED
|
142
|
143
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
HZ/suSeq Group
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
Baseline Characteristics
A Study on the Immune Response and Safety of a Vaccine Against Herpes Zoster in Adults Aged 50 Years and Older in India
Baseline characteristics by cohort
| Measure |
HZ/suSeq Group
n=143 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=145 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
Total
n=288 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.9 Years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
58.2 Years
STANDARD_DEVIATION 7.0 • n=7 Participants
|
58.5 Years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
99 Participants
n=5 Participants
|
97 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN - CENTRAL / SOUTH ASIAN HERITAGE
|
140 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
281 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
ASIAN - SOUTH EAST ASIAN HERITAGE
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 1 month post-Dose 2 of study intervention administration (Month 3)Population: This analysis was performed on the Per Protocol Set, which included all eligible participants who received all doses as per protocol, complied with allowed dosing/blood draw intervals, without intercurrent conditions that may have interfered with immunogenicity, without prohibited concomitant medication/vaccination and with immunogenicity results available at the specified time point post-Dose 2.
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.
Outcome measures
| Measure |
HZ/suSeq Group
n=126 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=129 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Percentage of Participants Showing a Vaccine Response for Anti-glycoprotein E (gE)
|
85.7 Percentage of participants
Interval 78.4 to 91.3
|
7.8 Percentage of participants
Interval 3.8 to 13.8
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 2 of study intervention administration (Month 3)Population: This analysis was performed on the Per Protocol Set, which included all eligible participants who received all doses as per protocol, complied with allowed dosing/blood draw intervals, without intercurrent conditions that may have interfered with immunogenicity, without prohibited concomitant medication/vaccination and with immunogenicity results available at the specified time point post-Dose 2.
Anti-gE antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as GMCs in milli-international units per milliliter (mIU/mL).
Outcome measures
| Measure |
HZ/suSeq Group
n=126 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=129 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Anti-gE Antibody Concentrations Expressed as Geometric Mean Concentrations (GMCs) and Between-group GMC Ratios
|
26863.85 mIU/mL
Interval 20125.47 to 35858.35
|
1360.48 mIU/mL
Interval 1134.23 to 1631.85
|
SECONDARY outcome
Timeframe: Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2)Population: This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention and with the diary cards completed post-each study intervention dose.
The assessed solicited administration site events included injection site erythema, pain, pruritus and swelling.
Outcome measures
| Measure |
HZ/suSeq Group
n=143 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=145 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Administration Site Events
Erythema, post-Dose 1
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Erythema, post-Dose 2
|
0.7 Percentage of participants
Interval 0.0 to 3.9
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Erythema, Across doses
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Pain, post-Dose 1
|
53.1 Percentage of participants
Interval 44.6 to 61.5
|
33.8 Percentage of participants
Interval 26.2 to 42.1
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Pain, post-Dose 2
|
46.5 Percentage of participants
Interval 38.1 to 55.0
|
37.8 Percentage of participants
Interval 29.8 to 46.2
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Pain, Across doses
|
67.1 Percentage of participants
Interval 58.8 to 74.8
|
49.0 Percentage of participants
Interval 40.6 to 57.4
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Pruritus, post-Dose 1
|
9.1 Percentage of participants
Interval 4.9 to 15.0
|
8.3 Percentage of participants
Interval 4.3 to 14.0
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Pruritus, post-Dose 2
|
12.7 Percentage of participants
Interval 7.7 to 19.3
|
6.3 Percentage of participants
Interval 2.9 to 11.6
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Pruritus, Across doses
|
20.3 Percentage of participants
Interval 14.0 to 27.8
|
13.1 Percentage of participants
Interval 8.1 to 19.7
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Swelling, post-Dose 1
|
1.4 Percentage of participants
Interval 0.2 to 5.0
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Swelling, post-Dose 2
|
0.7 Percentage of participants
Interval 0.0 to 3.9
|
0 Percentage of participants
Interval 0.0 to 2.5
|
|
Percentage of Participants Reporting Solicited Administration Site Events
Swelling, Across doses
|
2.1 Percentage of participants
Interval 0.4 to 6.0
|
0 Percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: Within 7 days after each study intervention dose and across doses (vaccine/placebo administered at Day 1 and Month 2)Population: This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention and with the diary cards completed post-each study intervention dose.
The assessed solicited systemic events included fatigue, fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, myalgia and shivering.
Outcome measures
| Measure |
HZ/suSeq Group
n=143 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=145 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Percentage of Participants Reporting Solicited Systemic Events
Headache, post-Dose 2
|
20.4 Percentage of participants
Interval 14.1 to 28.0
|
11.9 Percentage of participants
Interval 7.1 to 18.4
|
|
Percentage of Participants Reporting Solicited Systemic Events
Fatigue, post-Dose 1
|
32.2 Percentage of participants
Interval 24.6 to 40.5
|
15.2 Percentage of participants
Interval 9.8 to 22.1
|
|
Percentage of Participants Reporting Solicited Systemic Events
Fatigue, post-Dose 2
|
35.2 Percentage of participants
Interval 27.4 to 43.7
|
14.7 Percentage of participants
Interval 9.3 to 21.6
|
|
Percentage of Participants Reporting Solicited Systemic Events
Fatigue, Across doses
|
44.8 Percentage of participants
Interval 36.4 to 53.3
|
24.1 Percentage of participants
Interval 17.4 to 31.9
|
|
Percentage of Participants Reporting Solicited Systemic Events
Fever, post-Dose 1
|
26.6 Percentage of participants
Interval 19.5 to 34.6
|
6.9 Percentage of participants
Interval 3.4 to 12.3
|
|
Percentage of Participants Reporting Solicited Systemic Events
Fever, post-Dose 2
|
17.6 Percentage of participants
Interval 11.7 to 24.9
|
3.5 Percentage of participants
Interval 1.1 to 8.0
|
|
Percentage of Participants Reporting Solicited Systemic Events
Fever, Across doses
|
28.0 Percentage of participants
Interval 20.8 to 36.1
|
9.7 Percentage of participants
Interval 5.4 to 15.7
|
|
Percentage of Participants Reporting Solicited Systemic Events
Gastrointestinal symptoms, post-Dose 1
|
4.2 Percentage of participants
Interval 1.6 to 8.9
|
2.1 Percentage of participants
Interval 0.4 to 5.9
|
|
Percentage of Participants Reporting Solicited Systemic Events
Gastrointestinal symptoms, post-Dose 2
|
2.8 Percentage of participants
Interval 0.8 to 7.1
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
|
Percentage of Participants Reporting Solicited Systemic Events
Gastrointestinal symptoms, Across doses
|
7.0 Percentage of participants
Interval 3.4 to 12.5
|
2.8 Percentage of participants
Interval 0.8 to 6.9
|
|
Percentage of Participants Reporting Solicited Systemic Events
Headache, post-Dose 1
|
16.1 Percentage of participants
Interval 10.5 to 23.1
|
13.1 Percentage of participants
Interval 8.1 to 19.7
|
|
Percentage of Participants Reporting Solicited Systemic Events
Headache, Across doses
|
28.7 Percentage of participants
Interval 21.4 to 36.8
|
22.8 Percentage of participants
Interval 16.2 to 30.5
|
|
Percentage of Participants Reporting Solicited Systemic Events
Myalgia, post-Dose 1
|
16.8 Percentage of participants
Interval 11.1 to 23.9
|
2.8 Percentage of participants
Interval 0.8 to 6.9
|
|
Percentage of Participants Reporting Solicited Systemic Events
Myalgia, post-Dose 2
|
13.4 Percentage of participants
Interval 8.3 to 20.1
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
|
Percentage of Participants Reporting Solicited Systemic Events
Myalgia, Across doses
|
22.4 Percentage of participants
Interval 15.8 to 30.1
|
3.4 Percentage of participants
Interval 1.1 to 7.9
|
|
Percentage of Participants Reporting Solicited Systemic Events
Shivering, post-Dose 1
|
4.9 Percentage of participants
Interval 2.0 to 9.8
|
4.1 Percentage of participants
Interval 1.5 to 8.8
|
|
Percentage of Participants Reporting Solicited Systemic Events
Shivering, post-Dose 2
|
4.9 Percentage of participants
Interval 2.0 to 9.9
|
1.4 Percentage of participants
Interval 0.2 to 5.0
|
|
Percentage of Participants Reporting Solicited Systemic Events
Shivering, Across doses
|
8.4 Percentage of participants
Interval 4.4 to 14.2
|
5.5 Percentage of participants
Interval 2.4 to 10.6
|
SECONDARY outcome
Timeframe: Within 30 days after any study intervention dose administration (vaccine/placebo administered at Day 1 and Month 2)Population: This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention.
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.
Outcome measures
| Measure |
HZ/suSeq Group
n=143 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=145 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Percentage of Participants Reporting Unsolicited Adverse Events (AEs)
|
13.3 Percentage of participants
Interval 8.2 to 20.0
|
13.1 Percentage of participants
Interval 8.1 to 19.7
|
SECONDARY outcome
Timeframe: From Dose 1 (Day 1) up to 30 days post-last study intervention dosePopulation: This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention.
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.
Outcome measures
| Measure |
HZ/suSeq Group
n=143 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=145 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Percentage of Participants Reporting Serious Adverse Events (SAEs)
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
0 Percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: From Dose 1 (Day 1) up to 30 days post-last study intervention dosePopulation: This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention.
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.
Outcome measures
| Measure |
HZ/suSeq Group
n=143 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=145 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Percentage of Participants Reporting Potential Immune-mediated Diseases (pIMDs)
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: From Dose 1 (Day 1) up to study end (Month 8)Population: This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention.
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.
Outcome measures
| Measure |
HZ/suSeq Group
n=143 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=145 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Percentage of Participants Reporting SAEs
|
0.7 Percentage of participants
Interval 0.0 to 3.8
|
1.4 Percentage of participants
Interval 0.2 to 4.9
|
SECONDARY outcome
Timeframe: From Dose 1 (Day 1) up to study end (Month 8)Population: This analysis was performed on the Exposed Set, which included all participants who received at least 1 dose of the study intervention.
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.
Outcome measures
| Measure |
HZ/suSeq Group
n=143 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=145 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Percentage of Participants Reporting pIMDs
|
0 Percentage of participants
Interval 0.0 to 2.5
|
0 Percentage of participants
Interval 0.0 to 2.5
|
SECONDARY outcome
Timeframe: At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3)Population: This analysis was performed on the Per Protocol Set, which included all eligible participants who received all doses as per protocol, complied with allowed dosing/blood draw intervals, without intercurrent conditions that may have interfered with immunogenicity, without prohibited concomitant medication/vaccination and with immunogenicity results available at the specified time points pre- and post-Dose 2.
Anti-gE antibody concentrations were determined by ELISA and expressed as GMCs in mIU/mL.
Outcome measures
| Measure |
HZ/suSeq Group
n=126 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=129 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Anti-gE Antibody Concentrations Expressed as GMCs
At Day 1
|
1210.86 mIU/mL
Interval 982.17 to 1492.79
|
1217.81 mIU/mL
Interval 1019.01 to 1455.39
|
|
Anti-gE Antibody Concentrations Expressed as GMCs
At Month 3
|
26863.85 mIU/mL
Interval 20125.47 to 35858.35
|
1360.48 mIU/mL
Interval 1134.23 to 1631.85
|
SECONDARY outcome
Timeframe: At pre-study intervention administration (Day 1) and at 1 month post-Dose 2 of study intervention administration (Month 3)Population: This analysis was performed on the Per Protocol Set, which included all eligible participants who received all doses as per protocol, complied with allowed dosing/blood draw intervals, without intercurrent conditions that may have interfered with immunogenicity, without prohibited concomitant medication/vaccination and with immunogenicity results available at the specified time points pre- and post-Dose 2.
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).
Outcome measures
| Measure |
HZ/suSeq Group
n=126 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=129 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Percentage of Participants Seropositive for Anti-gE Antibodies
At Day 1
|
97.6 Percentage of participants
Interval 93.2 to 99.5
|
96.9 Percentage of participants
Interval 92.3 to 99.1
|
|
Percentage of Participants Seropositive for Anti-gE Antibodies
At Month 3
|
99.2 Percentage of participants
Interval 95.7 to 100.0
|
100 Percentage of participants
Interval 97.2 to 100.0
|
SECONDARY outcome
Timeframe: At 1 month post-Dose 2 of study intervention administration (Month 3) compared to pre-study intervention administration (Day 1)Population: This analysis was performed on the Per Protocol Set, which included all eligible participants who received all doses as per protocol, complied with allowed dosing/blood draw intervals, without intercurrent conditions that may have interfered with immunogenicity, without prohibited concomitant medication/vaccination and with immunogenicity results available at the specified time points pre- and post-Dose 2.
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.
Outcome measures
| Measure |
HZ/suSeq Group
n=126 Participants
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=129 Participants
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Mean Geometric Increase (MGI) of Anti-gE Antibody Concentrations
|
22.19 Ratio
Interval 15.46 to 31.83
|
1.12 Ratio
Interval 0.92 to 1.36
|
Adverse Events
HZ/suSeq Group
Serious events: 1 serious events
Other events: 103 other events
Deaths: 0 deaths
Placebo Group
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HZ/suSeq Group
n=143 participants at risk
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=145 participants at risk
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.00%
0/143 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.69%
1/145 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/143 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.69%
1/145 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Infections and infestations
Pneumonia
|
0.70%
1/143 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.00%
0/145 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
Other adverse events
| Measure |
HZ/suSeq Group
n=143 participants at risk
Participants randomized to the HZ/su group received two doses of HZ/su vaccine, administered at Day 1 and Month 2.
|
Placebo Group
n=145 participants at risk
Participants randomized to the Placebo group received two doses of Placebo, administered at Day 1 and Month 2.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/143 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
1.4%
2/145 • Number of events 2 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
3/143 • Number of events 3 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
5.5%
8/145 • Number of events 8 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
7.0%
10/143 • Number of events 10 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
2.8%
4/145 • Number of events 4 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
3/143 • Number of events 3 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
1.4%
2/145 • Number of events 2 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
General disorders
Administration site erythema
|
0.70%
1/143 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.00%
0/145 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
General disorders
Administration site pain
|
67.1%
96/143 • Number of events 142 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
49.0%
71/145 • Number of events 103 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
General disorders
Administration site swelling
|
2.1%
3/143 • Number of events 3 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.00%
0/145 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
General disorders
Chills
|
8.4%
12/143 • Number of events 14 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
5.5%
8/145 • Number of events 8 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
General disorders
Fatigue
|
44.8%
64/143 • Number of events 97 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
24.8%
36/145 • Number of events 46 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
General disorders
Pyrexia
|
29.4%
42/143 • Number of events 65 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
11.0%
16/145 • Number of events 17 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Infections and infestations
Nasopharyngitis
|
1.4%
2/143 • Number of events 2 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
1.4%
2/145 • Number of events 2 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
2/143 • Number of events 2 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.00%
0/145 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/143 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.69%
1/145 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.70%
1/143 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.00%
0/145 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.70%
1/143 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.00%
0/145 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.70%
1/143 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.00%
0/145 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
23.8%
34/143 • Number of events 45 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
4.8%
7/145 • Number of events 7 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.70%
1/143 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.00%
0/145 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Nervous system disorders
Headache
|
29.4%
42/143 • Number of events 54 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
25.5%
37/145 • Number of events 43 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.70%
1/143 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.69%
1/145 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.3%
29/143 • Number of events 31 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
13.1%
19/145 • Number of events 21 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.70%
1/143 • Number of events 1 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
0.00%
0/145 • Solicited administration site and systemic AEs: during the 7-day (Days 1-7) follow-up period after vaccination; Unsolicited AEs: during the 30-day (Days 1-30) follow-up period after vaccination; SAEs: from Dose 1 (Day 1) up to study end (Month 8).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER