Trial Outcomes & Findings for Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial) (NCT NCT02538341)
NCT ID: NCT02538341
Last Updated: 2021-11-23
Results Overview
Study protocol defined measure for immunogenicity samples.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
617 participants
Primary outcome timeframe
6 weeks post vaccination
Results posted on
2021-11-23
Participant Flow
Participant milestones
| Measure |
Zoster Vaccine Live (Zostavax)
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
310
|
307
|
|
Overall Study
Week 6 (Primary Outcome)
|
303
|
299
|
|
Overall Study
Month 6 (Safety Outcome)
|
276
|
260
|
|
Overall Study
1 Year Visit
|
254
|
0
|
|
Overall Study
COMPLETED
|
254
|
260
|
|
Overall Study
NOT COMPLETED
|
56
|
47
|
Reasons for withdrawal
| Measure |
Zoster Vaccine Live (Zostavax)
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
51
|
46
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Death
|
2
|
0
|
Baseline Characteristics
Safety and Effectiveness of Live Zoster Vaccine in Anti-Tumor Necrosis Factor (TNF) Users (VERVE Trial)
Baseline characteristics by cohort
| Measure |
Zoster Vaccine Live (Zostavax)
n=310 Participants
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
n=307 Participants
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
Total
n=617 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
62.7 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
62.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Age, Customized
Age · 50-59
|
126 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Age, Customized
Age · 60-69
|
125 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
267 Participants
n=5 Participants
|
|
Age, Customized
Age · 70-79
|
50 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Age, Customized
Age · 80-89
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Customized
Age · 90-99
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
207 Participants
n=5 Participants
|
201 Participants
n=7 Participants
|
408 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
202 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
399 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
81 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic
|
208 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
402 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other Ethnicity
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Unknown/ Not reported
|
81 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
310 participants
n=5 Participants
|
307 participants
n=7 Participants
|
617 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post vaccinationPopulation: Zoster vaccine live arm 7 did not complete Week 6; 5 lost to follow-up, 2 withdrew consent. Placebo arm 8 did not complete Week 6; 5 lost to follow-up, 3 withdrew consent. Zoster vaccine live arm 300 immunogenicity samples collected, 294 useable immunoglobulin G (IgG) samples, 287 usable immunoglobulin G (IgG) sample pairs. For the placebo arm 298 immunogenicity samples collected, 289 useable immunoglobulin G (IgG) samples, 259 usable immunoglobulin G (IgG) sample pairs.
Study protocol defined measure for immunogenicity samples.
Outcome measures
| Measure |
Zoster Vaccine Live (Zostavax)
n=287 IgG samples pairs
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
n=289 IgG samples pairs
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Immunoglobulin G (IgG) Levels From Baseline at 6 Weeks
|
1.33 GMFR (Geometric Mean Fold Rise )
Interval 1.17 to 1.51
|
1.02 GMFR (Geometric Mean Fold Rise )
Interval 0.91 to 1.14
|
PRIMARY outcome
Timeframe: 6 weeks post vaccinationPopulation: Zoster vaccine live arm 7 did not complete Week 6; 5 lost to follow-up, 2 withdrew consent. Placebo arm 8 did not complete Week 6; 5 lost to follow-up, 3 withdrew consent. For the zoster vaccine live arm 300 immunogenicity samples collected, 290 useable interferon gamma (IFNg) samples, 259 usable interferon gamma (IFNg) sample pairs. For the placebo arm 298 immunogenicity samples collected, 289 useable interferon gamma (IFNg) samples, 275 usable interferon gamma (IFNg)sample pairs.
Study protocol defined measure for immunogenicity samples.
Outcome measures
| Measure |
Zoster Vaccine Live (Zostavax)
n=259 lab samples pairs
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
n=275 lab samples pairs
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Enzyme-linked Immune Absorbent Spot (ELISpot) Interferon Gamma (IFNg) Levels From Baseline at 6 Weeks
|
1.39 GMFR (Geometric Mean Fold Rise )
Interval 1.07 to 1.82
|
1.15 GMFR (Geometric Mean Fold Rise )
Interval 0.88 to 1.5
|
SECONDARY outcome
Timeframe: Baseline to 1 yearPopulation: Zoster vaccine live arm 56 did not complete Year 1; 51 lost to follow-up, 3 withdrew consent, 2 deaths prior to month 6. Vaccine arm only. Placebo arm not applicable for this exploratory outcome. For the zoster vaccine live arm 131 immunogenicity samples collected, 122 useable immunoglobulin G (IgG) samples, 114 usable immunoglobulin G (IgG) sample pairs.
Study defined measure from labs. GMFR (Geometric Mean Fold Rise ) in varicella zoster virus (VZV) glycoprotein enzyme-linked immunosorbent assay (gpELISA) immunoglobulin G (IgG) levels
Outcome measures
| Measure |
Zoster Vaccine Live (Zostavax)
n=114 lab samples
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Immunoglobulin G (IgG) Levels From Baseline at 1 Year
≤ Baseline
|
41 lab samples
|
—
|
|
GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Immunoglobulin G (IgG) Levels From Baseline at 1 Year
Within 20%
|
6 lab samples
|
—
|
|
GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Immunoglobulin G (IgG) Levels From Baseline at 1 Year
> 20%
|
67 lab samples
|
—
|
SECONDARY outcome
Timeframe: Baseline to 1 yearPopulation: Zoster vaccine live arm 56 did not complete Year 1; 51 lost to follow-up, 3 withdrew consent, 2 deaths prior to month 6. Vaccine arm only. Placebo arm not applicable. For the zoster vaccine live arm 131 immunogenicity samples collected, 125 useable interferon gamma (IFNg) samples, 116 usable interferon gamma (IFNg) sample pairs.
Study defined measures from labs. GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) enzyme-linked immune absorbent spot (ELISpot) interferon gamma (IFNg)
Outcome measures
| Measure |
Zoster Vaccine Live (Zostavax)
n=116 lab samples
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Enzyme-linked Immune Absorbent Spot (ELISpot) Interferon Gamma (IFNg) Levels From Baseline at 1 Year
≤ Baseline
|
87 lab samples
|
—
|
|
GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Enzyme-linked Immune Absorbent Spot (ELISpot) Interferon Gamma (IFNg) Levels From Baseline at 1 Year
Within 20%
|
2 lab samples
|
—
|
|
GMFR (Geometric Mean Fold Rise ) in Varicella Zoster Virus (VZV) Enzyme-linked Immune Absorbent Spot (ELISpot) Interferon Gamma (IFNg) Levels From Baseline at 1 Year
> 20%
|
27 lab samples
|
—
|
SECONDARY outcome
Timeframe: "Placebo Normal Saline Arm/Group was assessed up to 6 months and the "Zoster Vaccine Live (Zostavax)" Arm/Group was assessed up to 1 yearPopulation: Lab samples collected for testing for varicella
Evaluated all serious adverse events (SAEs) AND non-serious varicella zoster virus (VZV) events
Outcome measures
| Measure |
Zoster Vaccine Live (Zostavax)
n=4 lab sample
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
n=4 lab sample
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
Number of Samples With Confirmed Varicella
Total Samples Tested
|
4 lab sample
|
4 lab sample
|
|
Number of Samples With Confirmed Varicella
Total Sample with Confirmed Varicella
|
0 lab sample
|
0 lab sample
|
SECONDARY outcome
Timeframe: 42 days post vaccinationPopulation: 7 participants from the Zostavax arm and 8 participants from the placebo arm did not complete 6 week visit for various a reasons (e.g., lost to follow up, consent withdrawn , etc.)
Patient self report data in the form of a diary to include injection site reactions; symptoms of swelling, redness or tenderness. Diary was completed from study injection administration up to 6 week visit
Outcome measures
| Measure |
Zoster Vaccine Live (Zostavax)
n=303 Participants
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
n=299 Participants
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
Vaccine Tolerability Within 42 Days Following Vaccination.
|
60 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 42 days post vaccinationPopulation: 120 participants on Zostavax arm and 129 participants on placebo arms were non-rheumatoid arthritis participants.
Rheumatoid arthritis disease activity will be measured using the clinical disease activity index (CDAI). Clinical disease activity index (CDAI) is a measure of rheumatoid arthritis disease activity and is scored on a scale ranging from 0-76, with lower numbers indicated better control of disease. Values \<=10 are consistent with low disease activity or remission.
Outcome measures
| Measure |
Zoster Vaccine Live (Zostavax)
n=190 Participants
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
n=178 Participants
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
Evaluate Rheumatoid Arthritis Disease Activity Using the Clinical Disease Activity Index (CDAI)
CDAI at Baseline
|
9.54 score on a scale
Standard Deviation 10.6
|
9.34 score on a scale
Standard Deviation 9.77
|
|
Evaluate Rheumatoid Arthritis Disease Activity Using the Clinical Disease Activity Index (CDAI)
CDAI at week 6
|
10.48 score on a scale
Standard Deviation 10.93
|
10.31 score on a scale
Standard Deviation 10.87
|
|
Evaluate Rheumatoid Arthritis Disease Activity Using the Clinical Disease Activity Index (CDAI)
Changes in CDAI
|
0.77 score on a scale
Standard Deviation 7.33
|
0.98 score on a scale
Standard Deviation 8.55
|
Adverse Events
Zoster Vaccine Live (Zostavax)
Serious events: 10 serious events
Other events: 120 other events
Deaths: 3 deaths
Placebo Normal Saline
Serious events: 8 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Zoster Vaccine Live (Zostavax)
n=310 participants at risk
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
n=307 participants at risk
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal carcinoma
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Nervous system disorders
Pseudoseizures
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Nervous system disorders
Syncope and collapse
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Gastrointestinal disorders
Blocked Bowel
|
0.97%
3/310 • Number of events 3 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Infections and infestations
Respiratory Syncytial Virus Pneumonia
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Infections and infestations
Sepsis due to pyelonephritis
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 2 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Musculoskeletal and connective tissue disorders
Right groin pain secondary to edema of the right hip adductor
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Renal and urinary disorders
Kidney stone
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Renal and urinary disorders
Left Ureteral Obstruction
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Renal and urinary disorders
Pyelonephritis
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Vascular disorders
Elevated blood pressure
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Congenital, familial and genetic disorders
Death
|
0.97%
3/310 • Number of events 3 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
Other adverse events
| Measure |
Zoster Vaccine Live (Zostavax)
n=310 participants at risk
Zostavax (zoster vaccine live) is used to prevent herpes zoster virus (shingles) in people age 50 and older. Patients randomized to this arm will receive active Herpes Zoster Vaccine. It is administered as a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Herpes Zoster Vaccine
|
Placebo Normal Saline
n=307 participants at risk
Saline injection: patients randomized to this arm will receive a single 0.65 mL dose subcutaneously in the deltoid region of the upper arm.
Placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Eye disorders
Eye pain/Redness
|
0.65%
2/310 • Number of events 2 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.5%
14/310 • Number of events 14 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
3.6%
11/307 • Number of events 14 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
15.2%
47/310 • Number of events 61 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
2.3%
7/307 • Number of events 13 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Infections and infestations
Infection
|
2.6%
8/310 • Number of events 15 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
2.9%
9/307 • Number of events 18 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Gastrointestinal disorders
Anaphylaxis
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Back pain
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.65%
2/307 • Number of events 2 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Skin and subcutaneous tissue disorders
Bug Bites
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Fever, Flu like Symptom
|
2.9%
9/310 • Number of events 10 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
2.6%
8/307 • Number of events 12 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
4/310 • Number of events 6 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 2 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Skin and subcutaneous tissue disorders
Psoriasis Flare
|
0.65%
2/310 • Number of events 2 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.65%
2/307 • Number of events 2 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Injury, poisoning and procedural complications
Ankle Sprain
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Musculoskeletal and connective tissue disorders
Arthritis pain
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Skin and subcutaneous tissue disorders
Chelitis
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Cold
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Gastrointestinal disorders
Constipation
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Dizziness
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Musculoskeletal and connective tissue disorders
Edema
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Injury, poisoning and procedural complications
Foot and Groin Injury
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Headache , Migraine
|
0.65%
2/310 • Number of events 2 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.98%
3/307 • Number of events 3 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Sore Throat
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Skin and subcutaneous tissue disorders
Poison Ivy
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Injury, poisoning and procedural complications
Ruptured vericose vein
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Injury, poisoning and procedural complications
Sprained ankle
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Renal and urinary disorders
Angiomyolipoma
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Cyst
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Cat Bite
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Cardiac disorders
Heart Irregularities
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Skin and subcutaneous tissue disorders
Herpes sore
|
0.32%
1/310 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.00%
0/307 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Skin and subcutaneous tissue disorders
Hives
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Infections and infestations
Bursitis
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Canker sore
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
hidradenitis
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
Blood and lymphatic system disorders
Low Blood Sugar
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Lower Extremity Pain
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Law Pain
|
0.00%
0/310 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
0.33%
1/307 • Number of events 1 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
|
General disorders
Not Specifies
|
6.5%
20/310 • Number of events 24 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
2.3%
7/307 • Number of events 9 • Adverse events and serious adverse events (SAEs) within 42 days of vaccination (placebo and vaccine). 6 months (final safety assessment for placebo arm).Serious Adverse Events (SAEs) up to 1 year (final safety assessment for treatment arm).
Serious adverse events (SAEs) AND non-serious varicella zoster virus events. SAEs will include all that satisfy the FDA-accepted definition of SAEs (results in death, life threatening, results in or prolongs hospitalization, and any Herpes Zoster event). Adverse events (non-serious) include rashes,blisters,fever of greater than 101,sickness/illness. Also, any redness, swelling, tenderness of the injection site or any other body part.
|
Additional Information
Dr. Jeffrey R. Curtis
University of Alabama at Birmingham
Phone: 205-975-2176
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place