Herpes Zoster
Conditions
Brief summary
This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.
Detailed description
This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.
Interventions
BIOLOGICALZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous
One 0.65 mL injection subcutaneously on Day 1
BIOLOGICALZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous
One approximately 0.22 mL injection subcutaneously on Day 1
BIOLOGICALZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal
Two intradermal injections of approximately 0.15 mL each on Day 1
BIOLOGICALZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal
One intradermal injection of approximately 0.1 mL on Day 1
BIOLOGICALFull Dose Intradermal Placebo
Two intradermal placebo injections of approximately 0.15 mL each on Day 1
BIOLOGICALIntradermal Placebo
One intradermal placebo injection of approximately 0.1 mL on Day 1
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years * Temperature less than 100.4 °F on day of vaccination * Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination * In good health
Exclusion criteria
* History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin * Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals * Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella * Prior history of herpes zoster * Prior receipt of any varicella or zoster vaccine * Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination * On immunosuppressive therapy * Known or suspected immune dysfunction * Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits * Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine * Not ambulatory * Pregnant or breastfeeding * Use of nontopical antiviral therapy with activity against herpes viruses * Active untreated tuberculosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies | Baseline and 6 weeks following vaccine administration | VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value. |
| Number of Participants Reporting an Adverse Experience (AE) | Up to 42 days following vaccine administration | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience. |
| Number of Participants Reporting a Serious Adverse Experience (SAE) | Up to 42 days following vaccine administration | An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention. |
| Number of Participants Reporting a Serious Adverse Experience | Within 5 days after the blood draw at approximately 20 months following vaccine administration | An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention |
| Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Up to 5 days following vaccine administration | The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo. |
| Number of Participants Reporting Systemic Adverse Experiences | Up to 42 days following vaccine administration | Systemic AEs included all reported AEs except injection-site AEs |
| Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) | Up to 42 days following vaccine administration | Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Full Dose Subcutaneous Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. | 52 |
| 1/3 Dose Subcutaneous Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. | 34 |
| Full Dose Intradermal Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. | 34 |
| 1/3 Dose Intradermal Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. | 35 |
| 1/10 Dose Intradermal Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. | 34 |
| 1/27 Dose Intradermal Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study. | 34 |
| Total | 223 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Full Dose Subcutaneous | 1/3 Dose Subcutaneous | Full Dose Intradermal | 1/3 Dose Intradermal | 1/10 Dose Intradermal | 1/27 Dose Intradermal | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.9 years STANDARD_DEVIATION 7.7 | 60.5 years STANDARD_DEVIATION 7.5 | 62.1 years STANDARD_DEVIATION 8.5 | 61.2 years STANDARD_DEVIATION 8.7 | 61.6 years STANDARD_DEVIATION 8.1 | 60.1 years STANDARD_DEVIATION 7.1 | 60.8 years STANDARD_DEVIATION 7.9 |
| Sex: Female, Male Female | 31 Participants | 20 Participants | 17 Participants | 17 Participants | 16 Participants | 24 Participants | 125 Participants |
| Sex: Female, Male Male | 21 Participants | 14 Participants | 17 Participants | 18 Participants | 18 Participants | 10 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 52 | 10 / 34 | 27 / 34 | 23 / 35 | 21 / 34 | 19 / 34 | 5 / 39 |
| serious Total, serious adverse events | 0 / 52 | 0 / 34 | 0 / 34 | 0 / 35 | 0 / 34 | 0 / 34 | 0 / 39 |
Outcome results
Primary
Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies
VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.
Time frame: Baseline and 6 weeks following vaccine administration
Population: The population analyzed included participants who received vaccination and did not have any protocol deviations that may have interfered with the immune response.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Full Dose Subcutaneous | Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies | 1.74 Geometric mean fold change |
| 1/3 Dose Subcutaneous | Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies | 1.64 Geometric mean fold change |
| Full Dose Intradermal | Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies | 3.24 Geometric mean fold change |
| 1/3 Dose Intradermal | Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies | 2.45 Geometric mean fold change |
| 1/10 Dose Intradermal | Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies | 2.21 Geometric mean fold change |
| 1/27 Dose Intradermal | Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies | 1.64 Geometric mean fold change |
Primary
Number of Participants Reporting an Adverse Experience (AE)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Time frame: Up to 42 days following vaccine administration
Population: The population analyzed was all randomized participants who received study vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Dose Subcutaneous | Number of Participants Reporting an Adverse Experience (AE) | 30 participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting an Adverse Experience (AE) | 10 participants |
| Full Dose Intradermal | Number of Participants Reporting an Adverse Experience (AE) | 27 participants |
| 1/3 Dose Intradermal | Number of Participants Reporting an Adverse Experience (AE) | 23 participants |
| 1/10 Dose Intradermal | Number of Participants Reporting an Adverse Experience (AE) | 21 participants |
| 1/27 Dose Intradermal | Number of Participants Reporting an Adverse Experience (AE) | 19 participants |
Primary
Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)
Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.
Time frame: Up to 42 days following vaccine administration
Population: The population analyzed was all randomized participants who received study vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Dose Subcutaneous | Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) | 0 participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) | 0 participants |
| Full Dose Intradermal | Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) | 0 participants |
| 1/3 Dose Intradermal | Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) | 0 participants |
| 1/10 Dose Intradermal | Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) | 0 participants |
| 1/27 Dose Intradermal | Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like) | 0 participants |
Primary
Number of Participants Reporting a Serious Adverse Experience
An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention
Time frame: Within 5 days after the blood draw at approximately 20 months following vaccine administration
Population: The population analyzed was all randomized participants who received study vaccination and had a Month 20 visit and follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Dose Subcutaneous | Number of Participants Reporting a Serious Adverse Experience | 0 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting a Serious Adverse Experience | 0 Participants |
| Full Dose Intradermal | Number of Participants Reporting a Serious Adverse Experience | 0 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting a Serious Adverse Experience | 0 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting a Serious Adverse Experience | 0 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting a Serious Adverse Experience | 0 Participants |
Primary
Number of Participants Reporting a Serious Adverse Experience (SAE)
An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.
Time frame: Up to 42 days following vaccine administration
Population: The population analyzed was all randomized participants who received study vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Dose Subcutaneous | Number of Participants Reporting a Serious Adverse Experience (SAE) | 0 participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting a Serious Adverse Experience (SAE) | 0 participants |
| Full Dose Intradermal | Number of Participants Reporting a Serious Adverse Experience (SAE) | 0 participants |
| 1/3 Dose Intradermal | Number of Participants Reporting a Serious Adverse Experience (SAE) | 0 participants |
| 1/10 Dose Intradermal | Number of Participants Reporting a Serious Adverse Experience (SAE) | 0 participants |
| 1/27 Dose Intradermal | Number of Participants Reporting a Serious Adverse Experience (SAE) | 0 participants |
Primary
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.
Time frame: Up to 5 days following vaccine administration
Population: The population analyzed was all randomized participants who received study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site haematoma | 2 Participants |
| Full Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site anaesthesia | 0 Participants |
| Full Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site erythema | 16 Participants |
| Full Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pruritus | 1 Participants |
| Full Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pain | 15 Participants |
| Full Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site induration | 5 Participants |
| Full Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site rash | 1 Participants |
| Full Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site scab | 0 Participants |
| Full Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site swelling | 13 Participants |
| Full Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Any injection-site AE | 27 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site anaesthesia | 0 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site rash | 0 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site scab | 0 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site erythema | 5 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site swelling | 4 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site haematoma | 0 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site induration | 2 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Any injection-site AE | 7 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pain | 5 Participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pruritus | 2 Participants |
| Full Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site erythema | 26 Participants |
| Full Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site rash | 0 Participants |
| Full Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site haematoma | 0 Participants |
| Full Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pruritus | 3 Participants |
| Full Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site induration | 12 Participants |
| Full Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pain | 8 Participants |
| Full Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site anaesthesia | 0 Participants |
| Full Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site swelling | 13 Participants |
| Full Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site scab | 1 Participants |
| Full Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Any injection-site AE | 27 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site anaesthesia | 1 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site erythema | 20 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pruritus | 3 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pain | 9 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site swelling | 8 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Any injection-site AE | 22 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site scab | 0 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site haematoma | 0 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site rash | 0 Participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site induration | 12 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site swelling | 6 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site rash | 0 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site scab | 0 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site induration | 11 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pruritus | 1 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site anaesthesia | 0 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site erythema | 16 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pain | 5 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site haematoma | 0 Participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Any injection-site AE | 19 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site scab | 0 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site rash | 0 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Any injection-site AE | 19 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site anaesthesia | 0 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site haematoma | 0 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site induration | 10 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pain | 6 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pruritus | 1 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site erythema | 18 Participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site swelling | 7 Participants |
| Placebo | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site induration | 1 Participants |
| Placebo | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site swelling | 2 Participants |
| Placebo | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site scab | 0 Participants |
| Placebo | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site haematoma | 0 Participants |
| Placebo | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site erythema | 4 Participants |
| Placebo | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site anaesthesia | 0 Participants |
| Placebo | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Any injection-site AE | 5 Participants |
| Placebo | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pain | 0 Participants |
| Placebo | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site rash | 0 Participants |
| Placebo | Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC) | Injection-site pruritus | 0 Participants |
Primary
Number of Participants Reporting Systemic Adverse Experiences
Systemic AEs included all reported AEs except injection-site AEs
Time frame: Up to 42 days following vaccine administration
Population: The population analyzed was all randomized participants who received study vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Dose Subcutaneous | Number of Participants Reporting Systemic Adverse Experiences | 12 participants |
| 1/3 Dose Subcutaneous | Number of Participants Reporting Systemic Adverse Experiences | 6 participants |
| Full Dose Intradermal | Number of Participants Reporting Systemic Adverse Experiences | 6 participants |
| 1/3 Dose Intradermal | Number of Participants Reporting Systemic Adverse Experiences | 4 participants |
| 1/10 Dose Intradermal | Number of Participants Reporting Systemic Adverse Experiences | 5 participants |
| 1/27 Dose Intradermal | Number of Participants Reporting Systemic Adverse Experiences | 6 participants |