Healthy
Conditions
Brief summary
This study compared the safety and tolerability profile of a higher potency investigational vaccine to that of the investigational vaccine at a lower potency dose.
Interventions
BIOLOGICALComparator: Varicella Zoster Virus Vaccine
Single 0.65 mL subcutaneous injection of higher potency zoster vaccine (\ 207,000 plaque-forming units \[PFU\]/0.65-mL dose)
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy individuals 50 years of age or older with a history of chickenpox who have not had herpes zoster
Exclusion criteria
: * Preexisting conditions that might affect vaccine safety such as conditions that inhibit an immune response
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) | Day 1-42 post vaccination | The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level. |
| Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter) | Day 1-5 postvaccination | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions | Day 1-42 postvaccination | Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be varicelliform rash by the study physician and polymerase chain reaction (PCR). |
| Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes | Day 1-42 postvaccination | Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be zosteriform rash by the study physician and polymerase chain reaction (PCR). |
| Number of Participants With Fevers ≥101.0°F [≥38.3°C] | Day 1-21 postvaccination | Maximum reported oral or equivalent temperature ≥101.0°F \[≥38.3°C\] was reported Day 1 through Day 21 postvaccination. |
Participant flow
Recruitment details
Participants were recruited at 18 sites in the United States, Canada, and Europe Prime Therapy Period: 30-Oct-2003 to 07-Jun-2004 Cutoff date for in-house data: 24-Aug-2004
Participants by arm
| Arm | Count |
|---|---|
| Zoster Vaccine Higher Potency Higher potency Zoster vaccine (approximately 207,000 plaque-forming units \[PFU\]), 1 subcutaneous 0.65 mL injection | 461 |
| Zoster Vaccine Lower Potency Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection | 234 |
| Total | 695 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Other | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Zoster Vaccine Lower Potency | Total | Zoster Vaccine Higher Potency |
|---|---|---|---|
| Age, Continuous | 65.6 years STANDARD_DEVIATION 9.69 | 65.4 years STANDARD_DEVIATION 9.34 | 65.2 years STANDARD_DEVIATION 9.16 |
| Race/Ethnicity, Customized Asian | 6 participants | 16 participants | 10 participants |
| Race/Ethnicity, Customized Black | 4 participants | 10 participants | 6 participants |
| Race/Ethnicity, Customized Hispanic American | 8 participants | 18 participants | 10 participants |
| Race/Ethnicity, Customized Multi-Racial | 2 participants | 3 participants | 1 participants |
| Race/Ethnicity, Customized Native American | 0 participants | 2 participants | 2 participants |
| Race/Ethnicity, Customized White | 214 participants | 646 participants | 432 participants |
| Sex: Female, Male Female | 134 Participants | 416 Participants | 282 Participants |
| Sex: Female, Male Male | 100 Participants | 279 Participants | 179 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 296 / 459 | 141 / 234 |
| serious Total, serious adverse events | 4 / 459 | 1 / 234 |
Outcome results
Primary
Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter)
Time frame: Day 1-5 postvaccination
Population: The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zoster Vaccine Higher Potency | Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter) | With moderate or severe injection-site reaction | 79 Participants |
| Zoster Vaccine Higher Potency | Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter) | Without moderate or severe injection-site reaction | 380 Participants |
| Zoster Vaccine Lower Potency | Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter) | With moderate or severe injection-site reaction | 21 Participants |
| Zoster Vaccine Lower Potency | Number of Participants With Moderate or Severe Injection-site Pain/Tenderness/Soreness or Swelling (> 2 Inches at Largest Diameter) | Without moderate or severe injection-site reaction | 213 Participants |
Primary
Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs)
The incidence of vaccine-related SAEs occurring Day 1 through Day 42 postvaccination. Whether a serious clinical adverse experience occurring Day 1 through Day 42 postvaccination was vaccine-related was determined by the investigator who was a qualified physician . The difference in the risk of developing a vaccine-related SAE between the two groups was compared at the 2-sided 0.05 level.
Time frame: Day 1-42 post vaccination
Population: The population for the primary safety analysis consisted of all vaccinated participants who had safety follow-up data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zoster Vaccine Higher Potency | Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) | With vaccine-related SAEs | 0 Participants |
| Zoster Vaccine Higher Potency | Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) | Without vaccine-related SAEs | 459 Participants |
| Zoster Vaccine Lower Potency | Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) | With vaccine-related SAEs | 0 Participants |
| Zoster Vaccine Lower Potency | Number of Participants With Vaccine-related Serious Clinical Adverse Experiences (SAEs) | Without vaccine-related SAEs | 234 Participants |
Other Pre-specified
Number of Participants With Fevers ≥101.0°F [≥38.3°C]
Maximum reported oral or equivalent temperature ≥101.0°F \[≥38.3°C\] was reported Day 1 through Day 21 postvaccination.
Time frame: Day 1-21 postvaccination
Population: The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data. 5 participants in the Zoster Vaccine Higher Potency group and 3 participants in the Zoster Vaccine Lower Potency group were not included in this analysis since these participants were without a follow-up.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zoster Vaccine Higher Potency | Number of Participants With Fevers ≥101.0°F [≥38.3°C] | With max oral temp ≥101.0°F (≥38.3°C) | 4 Participants |
| Zoster Vaccine Higher Potency | Number of Participants With Fevers ≥101.0°F [≥38.3°C] | With max oral temp <101.0°F (<38.3°C) | 452 Participants |
| Zoster Vaccine Lower Potency | Number of Participants With Fevers ≥101.0°F [≥38.3°C] | With max oral temp ≥101.0°F (≥38.3°C) | 2 Participants |
| Zoster Vaccine Lower Potency | Number of Participants With Fevers ≥101.0°F [≥38.3°C] | With max oral temp <101.0°F (<38.3°C) | 229 Participants |
Other Pre-specified
Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes
Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be zosteriform rash by the study physician and polymerase chain reaction (PCR).
Time frame: Day 1-42 postvaccination
Population: The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zoster Vaccine Higher Potency | Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes | With zoster or rash, zosteriform | 3 Participants |
| Zoster Vaccine Higher Potency | Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes | Without zoster or rash, zosteriform | 456 Participants |
| Zoster Vaccine Lower Potency | Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes | With zoster or rash, zosteriform | 3 Participants |
| Zoster Vaccine Lower Potency | Number of Participants With Herpes Zoster (HZ) or HZ-like Rashes | Without zoster or rash, zosteriform | 231 Participants |
Other Pre-specified
Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions
Noninjection-site rash Day 1 through Day 42 postvaccination was reported by the participant to the investigator and confirmed to be varicelliform rash by the study physician and polymerase chain reaction (PCR).
Time frame: Day 1-42 postvaccination
Population: The population for the safety analyses consisted of all vaccinated participants who had safety follow-up data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zoster Vaccine Higher Potency | Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions | Without varicella or rash, varicelliform | 459 Participants |
| Zoster Vaccine Higher Potency | Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions | With varicella or rash, varicelliform | 0 Participants |
| Zoster Vaccine Lower Potency | Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions | Without varicella or rash, varicelliform | 234 Participants |
| Zoster Vaccine Lower Potency | Number of Participants With Varicella or Varicella-like Noninjection-site Rashes, Nondermatomal in Distribution With >100 Lesions | With varicella or rash, varicelliform | 0 Participants |