Herpes Zoster
Conditions
Brief summary
The purpose of the study is to evaluate the general safety of ZOSTAVAX™ in subjects 60 years of age or older as required by the FDA.
Interventions
BIOLOGICALZoster Vaccine, Live
single 0.65 mL Zoster Vaccine, Live injection. 6 month treatment period.
BIOLOGICALComparator: placebo
single 0.65 mL Placebo injection. 6 month treatment period.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 60+ years of Age * Signed an informed consent prior to the start of study * Non-Feverish, (less than 101.0°F / 38.3°C) on day of vaccination * Females must be postmenopausal or have a negative pregnancy test
Exclusion criteria
* A history of allergic reaction to any vaccine component (including gelatin or neomycin) * Prior receipt of any varicella or zoster vaccine * Any live virus vaccine administered within 4 weeks before the start of the study or scheduled during the 42 days after vaccination * Any inactivated virus vaccine, except for flu vaccine, administered within 7 days before the start of the study or scheduled during the 42 days after vaccination * Subject is pregnant or breastfeeding * Participation in an investigational drug or vaccine study within the last 30 days prior to the start of the study or expected during the 42 days after vaccination * An ongoing illness (including active untreated tuberculosis) that might interfere with or prevent the subject from completion of the study * Use of immunosuppressive therapy. Subjects taking corticosteroids such as prednisone should be excluded. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation * Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Examples of medical conditions associated with immune dysfunction include congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, or generalized malignancy. Subjects with a history of cancer who are not on active treatment and are not thought to have a weakened immune system at the time of enrollment will be eligible * Any active use of non-topical antiviral therapy including but not limited to acyclovir, famciclovir, valacyclovir, ganciclovir, foscarnet, brivudine, and cidofovir
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events Reported Within 42 Days Postvaccination | 42 Days | Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination | 6 months | Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement. |
Participant flow
Recruitment details
Phase IV First subject enrolled on 17-Sep-2007. Last subject enrolled on 19-Jun-2008. The last subject's last visit was 15-Jan-2009. The study was conducted at 46 study centers throughout the United States, Canada, Germany, Spain, and United Kingdom.
Participants by arm
| Arm | Count |
|---|---|
| ZOSTAVAX™ Represents the number of subjects according to the treatment (ZOSTAVAX™) received.
Excludes subjects who were not vaccinated. | 5,983 |
| Placebo Represents the number of subjects according to the treatment (placebo) received.
Excludes subjects who were not vaccinated. | 5,997 |
| Total | 11,980 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 20 | 16 |
| Overall Study | Lost to Follow-up | 45 | 30 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Violation | 4 | 2 |
| Overall Study | Screen failure | 1 | 0 |
| Overall Study | Withdrawal by Subject | 17 | 10 |
Baseline characteristics
| Characteristic | ZOSTAVAX™ | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 70.5 years STANDARD_DEVIATION 7.5 | 70.4 years STANDARD_DEVIATION 7.6 | 70.5 years STANDARD_DEVIATION 7.5 |
| Age, Customized 60 to 69 Years of Age | 3092 participants | 3113 participants | 6205 participants |
| Age, Customized 70 to 79 Years of Age | 1994 participants | 1986 participants | 3980 participants |
| Age, Customized ≥ 80 Years of Age | 897 participants | 898 participants | 1795 participants |
| Race/Ethnicity, Customized Black | 109 participants | 85 participants | 194 participants |
| Race/Ethnicity, Customized Other | 115 participants | 142 participants | 257 participants |
| Race/Ethnicity, Customized White | 5759 participants | 5770 participants | 11529 participants |
| Region Non-U.S. | 674 Participants | 685 Participants | 1359 Participants |
| Region U.S. | 5309 Participants | 5312 Participants | 10621 Participants |
| Sex: Female, Male Female | 3515 Participants | 3525 Participants | 7040 Participants |
| Sex: Female, Male Male | 2468 Participants | 2472 Participants | 4940 Participants |
| Type of Residence Assisted Living | 176 Participants | 162 Participants | 338 Participants |
| Type of Residence Independent Residential | 5790 Participants | 5821 Participants | 11611 Participants |
| Type of Residence Nursing Home | 17 Participants | 14 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 340 / 5,979 | 300 / 5,990 |
Outcome results
Primary
Serious Adverse Events Reported Within 42 Days Postvaccination
Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement.
Time frame: 42 Days
Population: All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up.~Death - Number of subjects that had a fatal serious adverse event with an onset date within the 42 day reporting period. The date of death may have occurred after 42 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZOSTAVAX™ | Serious Adverse Events Reported Within 42 Days Postvaccination | Serious Adverse Events (AEs) | 84 Participants |
| ZOSTAVAX™ | Serious Adverse Events Reported Within 42 Days Postvaccination | Serious AEs deemed vaccine-related by investigator | 2 Participants |
| ZOSTAVAX™ | Serious Adverse Events Reported Within 42 Days Postvaccination | Death | 6 Participants |
| Placebo | Serious Adverse Events Reported Within 42 Days Postvaccination | Serious Adverse Events (AEs) | 67 Participants |
| Placebo | Serious Adverse Events Reported Within 42 Days Postvaccination | Serious AEs deemed vaccine-related by investigator | 0 Participants |
| Placebo | Serious Adverse Events Reported Within 42 Days Postvaccination | Death | 5 Participants |
95% CI: [0.91, 1.73]
Secondary
Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination
Only Serious Adverse Events were collected and analyzed for this study. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an other important medical event based on medical judgement.
Time frame: 6 months
Population: All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™ or placebo) and had safety follow-up.~Death - Number of subjects that had a fatal serious adverse event with an onset date within the 182 day reporting period. The date of death may have occurred after 182 days.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ZOSTAVAX™ | Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination | Serious AEs | 340 Participants |
| ZOSTAVAX™ | Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination | Serious AEs deemed vaccine-related by investigator | 2 Participants |
| ZOSTAVAX™ | Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination | Death | 24 Participants |
| Placebo | Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination | Death | 17 Participants |
| Placebo | Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination | Serious AEs | 300 Participants |
| Placebo | Serious Adverse Events Reported Within 6 Months (Day 1 to 182) Postvaccination | Serious AEs deemed vaccine-related by investigator | 1 Participants |
95% CI: [0.98, 1.32]