Hantaan Virus Disease, Puumala Virus
Conditions
Brief summary
To evaluate the safety and reactogenicity of the hantaan virus (HTNV), puumala virus (PUUV), and combination HTNV/PUUV DNA vaccine candidates delivered to healthy adults
Detailed description
The development of DNA (deoxyribonucleic acid) vaccines, such as those to be utilized in this study, is based on the observation that antigen-encoding DNA plasmids can induce both cellular and humoral immune responses against various viral and bacterial pathogens. DNA vaccines are perceived as having a number of potential advantages over other types of vaccines. For example, DNA vaccines are easily constructed by recombinant technology; easily and inexpensively manufactured as a well-characterized molecule \[DNA plasmid\]; and at boost, not eliminated by prior immune response to the carrier or vector. Furthermore, as nonliving vaccines, they cannot lead to infection. The object of DNA vaccination is to deliver DNA into the nuclei of cells capable of presenting the encoded antigen to immune reactive cells that can elicit an immune response. The study will enroll 6 randomized groups of 12 subjects each, for a total of 72 subjects. This approach will ensure at least 60 subjects complete all vaccinations at around 10 subjects per group, taking possible attrition into account. Subjects will receive one dose of vaccine on each of Days 0, 28, and 56 either intramuscularly or intradermally by electroporation and will be followed until Day 220.
Interventions
COMBINATION_PRODUCTPuumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
The PUUV vaccine will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
COMBINATION_PRODUCTHantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
The HTNV vaccine will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
COMBINATION_PRODUCTHantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)
The HTNV vaccine will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
COMBINATION_PRODUCTPuumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)
The PUUV DNA vaccine will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
COMBINATION_PRODUCTHantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
The HTNV and PUUV vaccines will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
COMBINATION_PRODUCTHantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM)
The HTNV and PUUV vaccines will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
The Geneva Foundation
US Army Medical Research Institute of Infectious Diseases
Ichor Medical Systems Incorporated
U.S. Army Medical Research and Development Command
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
6 groups of 12 subjects each will receive varying vaccine dosages and vaccine candidate combinations
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at time of screening * Have demonstrated adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given the opportunity to retest after a review of the protocol information. Individuals who fail the quiz for the second time will not be enrolled. * Have provided written informed consent before screening * Subject is in good health as determined by past medical history, medication use, and abbreviated physical examination * Good health is defined by the absence of any medical condition described in the
Exclusion criteria
in a subject with a normal abbreviated physical examination including vital signs. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria: (1) first diagnosed within 3 months of enrollment, (2) is worsening in terms of clinical outcome in last 6 months, or (3) involves need for medication that may pose a risk to subject's safety or impede assessment of adverse events or immunogenicity if they participate in the study. * An abbreviated physical examination differs from a complete physical examination in that it does not include a genitourinary and rectal examination. * Available and able to participate for all study visits and procedures * Sexually active men and women of childbearing potential must agree to use an effective method of contraception from 30 days prior to the first study vaccination until 6 months after the last study vaccination. * A sexually active man is defined as one whose partner is a woman of childbearing potential (see definition below) and has not had a vasectomy performed \> 1 year prior to screening. They must agree not to father a child until 6 months after the last vaccination. These subjects must agree to use a barrier method of birth control (eg, either condom with spermicidal foam/gel/film/cream or partner usage of occlusive cap \[diaphragm or cervical/vault caps\] with spermicidal foam/gel/film/cream/suppository). * Women of childbearing potential are defined as those who have not been sterilized via tubal ligation, bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with history of documented radiological confirmation test at least 90 days after the procedure and are still menstruating or \< 1 year of the last menses if perimenopausal. For this study, an effective contraceptive method is defined as one that results in a failure rate of less than 1% per year when it is used consistently and correctly (see the Manual of Procedures \[MOP\] for a list of acceptable methods). * Female subjects agree to not donate eggs (ova, oocytes), and male subjects agree to not donate sperm from the start of screening until at least 6 months after the last vaccination. * Negative hantavirus PsVNA test result at screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Solicited Local Adverse Events (AEs) | Days 0-14 after injection | Summary of solicited local AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines |
| Summary of Solicited Systemic Adverse Events (AEs) | Days 0-14 after injection | Summary of solicited systemic AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Days 0-28 after injection | Subjects experiencing vaccine-related unsolicited AEs from the time of the first injection through 28 days following each injection |
| Proportion of Seropositive Subjects | Days 0, 28, 56, 84, 140 and 220 | Determination of seropositive subjects (defined as PsVNA50 ≥ 1:20) at each scheduled time point |
| Final Overall Rate of Seroconversion Over All Scheduled Time Points | Days 0, 28, 56, 84, 140 and 220 | Determination of the final overall rate of serconversion over all scheduled time points to study completion for each study group. Seroconversion is defined as a post-vaccination HTNV- or PUUV-specific titer of ≥1:40, or a minimum four-fold rise compared to baseline titer, and all study volunteers will begin the study with a baseline titer \<20 (ie, seronegative) |
| Geometric Mean Titer (GMT) of the PsVNA50 | Days 0, 28, 56, 84, 140 and 220 | GMT of the PsVNA50 for HTNV- and PUUV-specific neutralizing antibodies at each schedule time point for each study group and over all time points for each study group |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: 0.6 mg HTNV - Intradermal (ID) 0.1 mL 6.0 mg/mL HTNV DNA + 0.1 mL 0.9% saline (ID) The HTNV and PUUV DNA vaccines will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue. | 11 |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) 0.5 mL 6.0 mg/mL HTNV DNA + 0.5 mL 0.9% saline (IM) The HTNV and PUUV DNA vaccines will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue. | 12 |
| Group 3: 0.6 mg PUUV - Intradermal (ID) 0.1 mL 6.0 mg/mL PUUV DNA + 0.1 mL 0.9% saline (ID) The HTNV and PUUV DNA vaccines will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue. | 12 |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) 0.5 mL 6.0 mg/mL PUUV DNA + 0.5 mL 0.9% saline (IM) The HTNV and PUUV DNA vaccines will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue. | 12 |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) 0.1 mL 6.0 mg/mL HTNV DNA + 0.1 mL 6.0 mg/mL PUUV DNA (ID) The HTNV and PUUV DNA vaccines will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV and PUUV vaccines will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue. | 2 |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) 0.5 mL 6.0 mg/mL HTNV DNA + 0.5 mL 6.0 mg/mL PUUV DNA (IM) The HTNV and PUUV DNA vaccines will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM): The HTNV and PUUV vaccines will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue. | 12 |
| Total | 61 |
Baseline characteristics
| Characteristic | Total | Group 1: 0.6 mg HTNV - Intradermal (ID) | Group 2: 3.0 mg HTNV - Intramuscular (IM) | Group 3: 0.6 mg PUUV - Intradermal (ID) | Group 4: 3.0 mg PUUV - Intramuscular (IM) | Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 31.3 years | 27.2 years | 33.3 years | 29.8 years | 37.2 years | 31.5 years | 28.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 10 Participants | 12 Participants | 11 Participants | 11 Participants | 2 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized African American | 19 Participants | 3 Participants | 5 Participants | 2 Participants | 6 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Others | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 35 Participants | 6 Participants | 6 Participants | 8 Participants | 6 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Female | 44 Participants | 9 Participants | 8 Participants | 8 Participants | 9 Participants | 1 Participants | 9 Participants |
| Sex: Female, Male Male | 17 Participants | 2 Participants | 4 Participants | 4 Participants | 3 Participants | 1 Participants | 3 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 2 | 0 / 12 |
| other Total, other adverse events | 10 / 11 | 11 / 12 | 7 / 12 | 10 / 12 | 1 / 2 | 9 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 | 1 / 12 | 0 / 12 | 0 / 2 | 0 / 12 |
Outcome results
Primary
Summary of Solicited Local Adverse Events (AEs)
Summary of solicited local AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Time frame: Days 0-14 after injection
Population: Summary of solicited local AE for Groups 1 through Group 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Mild | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Mild | 2 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Severe | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | None | 7 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | None | 8 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | None | 2 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | None | 5 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | None | 6 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | None | 7 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | None | 7 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Severe | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Mild | 3 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | None | 6 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Mild | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Mild | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Mild | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Mild | 3 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Severe | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Severe | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | None | 3 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | None | 9 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Mild | 2 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Severe | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Mild | 2 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | None | 4 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Mild | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | None | 2 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Mild | 6 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | None | 2 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | None | 5 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | None | 3 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Moderate | 2 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Severe | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Mild | 5 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | None | 8 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | None | 5 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Mild | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Moderate | 2 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Mild | 4 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | None | 6 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | None | 8 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Mild | 6 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | None | 10 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | None | 3 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | None | 4 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Moderate | 2 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Mild | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Mild | 8 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | None | 4 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Mild | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | None | 10 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Mild | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Moderate | 3 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Mild | 5 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Mild | 3 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | None | 9 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Severe | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Moderate | 2 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Mild | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Mild | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | None | 7 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Moderate | 3 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Severe | 2 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | None | 9 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | None | 12 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Moderate | 2 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Moderate | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | None | 4 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Severe | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | None | 12 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Severe | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | None | 7 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | None | 3 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Mild | 5 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Moderate | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | None | 8 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Mild | 2 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | None | 2 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | None | 6 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Moderate | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | None | 6 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Severe | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | None | 6 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | None | 4 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | None | 8 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | None | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Moderate | 2 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | None | 9 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Mild | 2 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | None | 10 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Mild | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | None | 3 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Mild | 8 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | None | 3 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Mild | 8 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | None | 10 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | None | 9 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Mild | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Severe | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | None | 7 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Mild | 4 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | None | 4 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Mild | 7 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | None | 11 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | None | 7 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Mild | 5 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | None | 6 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Mild | 6 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | None | 1 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Mild | 1 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | None | 1 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Mild | 1 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Mild | 1 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | None | 1 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | None | 6 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | None | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | None | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Moderate | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Erythema | None | 6 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Ecchymosis | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | None | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | Mild | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Ecchymosis | None | 6 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Moderate | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Mild | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Erythema | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | Mild | 5 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Tenderness | None | 5 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Moderate | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | None | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Moderate | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | Mild | 6 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | Mild | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Pain | None | 4 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Severe | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Moderate | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | None | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Tenderness | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Mild | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Induration (Hardness)/Swelling | None | 9 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Severe | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Moderate | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Ecchymosis | None | 9 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 3 : Pain | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | Mild | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | None | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | Mild | 5 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Mild | 4 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Pain | None | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 1 : Erythema | None | 9 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Tenderness | Moderate | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Moderate | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Local Adverse Events (AEs) | Dose 2 : Induration (Hardness)/Swelling | Mild | 0 Participants |
Primary
Summary of Solicited Systemic Adverse Events (AEs)
Summary of solicited systemic AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Time frame: Days 0-14 after injection
Population: Summary of solicited systemic AE by Group and Dose Number, for Groups 1 through Group 6
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | None | 8 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | None | 4 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Mild | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | None | 8 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Mild | 2 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Mild | 4 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | None | 5 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Mild | 3 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | None | 4 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Mild | 2 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Severe | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | None | 4 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | None | 4 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | None | 7 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Mild | 3 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | None | 4 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | None | 10 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Mild | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Mild | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | None | 3 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Mild | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | None | 3 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | None | 10 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Mild | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Moderate | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | None | 3 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | None | 11 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | None | 6 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | None | 8 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | None | 11 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | None | 7 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | None | 8 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Moderate | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Mild | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | None | 8 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Severe | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | None | 7 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Mild | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | None | 10 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Mild | 3 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Mild | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | None | 9 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | None | 8 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | None | 6 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Mild | 3 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | None | 8 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Mild | 4 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Mild | 2 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Mild | 3 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | None | 8 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Moderate | 2 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | None | 10 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | None | 10 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Mild | 4 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Mild | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Moderate | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | None | 12 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Mild | 2 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Mild | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | None | 8 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Mild | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | None | 11 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Severe | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | None | 8 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | None | 12 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | None | 8 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Mild | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Moderate | 3 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | None | 10 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Moderate | 2 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | None | 12 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | None | 11 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Mild | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | None | 12 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | None | 12 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | None | 8 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | None | 7 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Mild | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | None | 7 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Mild | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | None | 8 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | None | 8 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | None | 8 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | None | 4 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | None | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Mild | 3 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | None | 2 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Mild | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Moderate | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | None | 4 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | None | 4 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | None | 4 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Severe | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | None | 4 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Mild | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Moderate | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | None | 10 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Mild | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | None | 9 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | None | 11 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | None | 11 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Mild | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Mild | 2 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Mild | 2 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | None | 9 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Mild | 2 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Mild | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | None | 10 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | None | 9 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Moderate | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Mild | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | None | 11 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Mild | 2 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | None | 12 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | None | 10 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | None | 11 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Moderate | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Mild | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Severe | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Mild | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Severe | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Moderate | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Severe | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Mild | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | None | 2 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | None | 9 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | None | 7 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | None | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | None | 12 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | None | 5 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | None | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Moderate | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | None | 10 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Mild | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | Mild | 4 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Fatigue | None | 7 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Tachypnea | None | 7 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Mild | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Tachypnea | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | None | 6 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Lymphadenopathy | None | 7 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Mild | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | None | 12 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | None | 12 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | None | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | None | 7 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Fatigue | None | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | None | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Lymphadenopathy | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Fatigue | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Mild | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Moderate | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Axillary Pain or Discomfort | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Myalgia (Body aches/Muscular pain) | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Moderate | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | None | 7 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | Mild | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Myalgia (Body aches/Muscular pain) | Mild | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Headache | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Mild | 3 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Axillary pain or discomfort | None | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Temperature (fever) | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 2: Headache | None | 7 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Lymphadenopathy | None | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Headache | Mild | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Temperature | Severe | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Tachypnea | Moderate | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 1: Myalgia (Body aches/Muscular Pain) | Moderate | 2 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Summary of Solicited Systemic Adverse Events (AEs) | Dose 3: Temperature (fever) | Moderate | 0 Participants |
Secondary
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Determination of the final overall rate of serconversion over all scheduled time points to study completion for each study group. Seroconversion is defined as a post-vaccination HTNV- or PUUV-specific titer of ≥1:40, or a minimum four-fold rise compared to baseline titer, and all study volunteers will begin the study with a baseline titer \<20 (ie, seronegative)
Time frame: Days 0, 28, 56, 84, 140 and 220
Population: 1. Proportion of Seroconversion to HTNV PsVNA by Group and by Day~2. Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 56 | 0.33 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 140 | 0.27 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 28 | 0.25 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 28 | 0 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 140 | 0 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 84 | 1 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 84 | 0 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 56 | 0 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 220 | 0.09 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 28 | 0 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 220 | 0 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 140 | 0 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 56 | 0.17 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 28 | 0.25 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 84 | 0.5 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 84 | 0.08 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 140 | 0.25 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 56 | 0 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 28 | 0 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 140 | 0.45 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 28 | 0 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 56 | 0 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 84 | 0.75 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 140 | 0.09 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 84 | 0 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 56 | 0.2 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 220 | 0 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 28 | 0 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 56 | 0.17 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 84 | 0.08 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 140 | 0.08 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 28 | 0.08 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 56 | 0.33 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 84 | 0.75 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 140 | 0.42 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 220 | 0.17 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 84 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 56 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 56 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 84 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 28 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 140 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 28 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 140 | 0 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 140 | 0 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 56 | 0 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 84 | 0.5 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 56 | 0 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 84 | 0 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 28 | 0 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 220 | 0 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 28 | 0 proportion of participants |
| Unknown | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 0 | — proportion of participants |
| Unknown | Final Overall Rate of Seroconversion Over All Scheduled Time Points | Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 0 | — proportion of participants |
Secondary
Geometric Mean Titer (GMT) of the PsVNA50
GMT of the PsVNA50 for HTNV- and PUUV-specific neutralizing antibodies at each schedule time point for each study group and over all time points for each study group
Time frame: Days 0, 28, 56, 84, 140 and 220
Population: 1. Geometric Mean Titers of HTNV PsVNA80 by Group and by Day~2. Geometric Mean Titers of PUUV PsVNA80 by Group and by Day
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 56 | 22.72 titers |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 140 | 28.26 titers |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 56 | 14.1 titers |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 140 | 14.1 titers |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 28 | 14.1 titers |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 84 | 118.48 titers |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 84 | 14.1 titers |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 28 | 28.68 titers |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 84 | 42.65 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 220 | 14.1 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 220 | 15.5 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 140 | 22.7 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 140 | 14.1 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 28 | 20.95 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 84 | 17.7 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 56 | 14.1 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 56 | 22.06 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 28 | 14.1 titers |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 28 | 14.1 titers |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 56 | 29.98 titers |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 84 | 15.93 titers |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 140 | 18.38 titers |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 28 | 14.1 titers |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 56 | 15.27 titers |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 84 | 84.75 titers |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 140 | 41.63 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 56 | 17.35 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 220 | 19.09 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 56 | 30.89 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 220 | 14.1 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 28 | 14.84 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 140 | 15.93 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 140 | 31.54 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 28 | 22.36 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 84 | 17.53 titers |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 84 | 69.97 titers |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 84 | 14.1 titers |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 56 | 14.1 titers |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 140 | 14.1 titers |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 28 | 14.1 titers |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 56 | 14.1 titers |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 28 | 14.1 titers |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 84 | 14.1 titers |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 140 | 14.1 titers |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 84 | 24.91 titers |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 84 | 21.57 titers |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 0 | 14.1 titers |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 220 | 14.1 titers |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 56 | 14.1 titers |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 220 | 14.58 titers |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 56 | 14.1 titers |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 28 | 15.63 titers |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Geometric Mean Titer (GMT) of the PsVNA50 | Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 28 | 14.1 titers |
Secondary
Proportion of Seropositive Subjects
Determination of seropositive subjects (defined as PsVNA50 ≥ 1:20) at each scheduled time point
Time frame: Days 0, 28, 56, 84, 140 and 220
Population: The planned enrolled sample size was 82 participants. A total of 61 participants were enrolled in the study. The reduction in total enrolled participants occurred due to the SARS-CoV-2 pandemic and study halt for ad Hoc Safety Monitoring Committee (SMC) review of an SAE required by the sponsor.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Proportion of Seropositive Subjects | Day 84 | 1 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Proportion of Seropositive Subjects | Day 28 | 0.63 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Proportion of Seropositive Subjects | Day 140 | 0.73 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Proportion of Seropositive Subjects | Day 0 | 0 proportion of participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Proportion of Seropositive Subjects | Day 56 | 0.67 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 140 | 0.5 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 0 | 0 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 56 | 0.58 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 220 | 0.45 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 28 | 0.42 proportion of participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 84 | 0.75 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Proportion of Seropositive Subjects | Day 56 | 0.4 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Proportion of Seropositive Subjects | Day 0 | 0 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Proportion of Seropositive Subjects | Day 140 | 0.09 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Proportion of Seropositive Subjects | Day 28 | 0.13 proportion of participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Proportion of Seropositive Subjects | Day 84 | 0.75 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 56 | 0.33 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 0 | 0 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 28 | 0.08 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 84 | 0.33 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 140 | 0.17 proportion of participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 220 | 0.08 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Proportion of Seropositive Subjects | Day 84 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Proportion of Seropositive Subjects | Day 28 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Proportion of Seropositive Subjects | Day 140 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Proportion of Seropositive Subjects | Day 56 | 0 proportion of participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Proportion of Seropositive Subjects | Day 0 | 0 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 220 | 0.17 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 84 | 0.5 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 28 | 0.14 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 56 | 0.5 proportion of participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Proportion of Seropositive Subjects | Day 0 | 0.08 proportion of participants |
Secondary
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Subjects experiencing vaccine-related unsolicited AEs from the time of the first injection through 28 days following each injection
Time frame: Days 0-28 after injection
Population: Unsolicited Events that occurred across groups (Group 1 through Group 6) from the time of the first injection through 28 days following each injection
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | AST elevation (Grade 3) | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Increased respiration | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Bacterial vaginitis | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nerve pain in limb | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Painful urination | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Sore Throat | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Fever | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nausea | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | COVID-19 | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pruritus | 4 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pus | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Scabbing | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lightheadedness | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Seizure | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | ALT elevation | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Muscle pain or spasms | 1 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Influenza | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Constipation | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Viral illness/colds | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lump in armpit | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Ulcerative colitis | 0 Participants |
| Group 1: 0.6 mg HTNV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Back Pain | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nerve pain in limb | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Constipation | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Increased respiration | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lightheadedness | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pruritus | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Bacterial vaginitis | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Seizure | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Painful urination | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lump in armpit | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | ALT elevation | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Sore Throat | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Influenza | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Fever | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Ulcerative colitis | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nausea | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Viral illness/colds | 1 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Muscle pain or spasms | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | COVID-19 | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Back Pain | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pus | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | AST elevation (Grade 3) | 0 Participants |
| Group 2: 3.0 mg HTNV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Scabbing | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Viral illness/colds | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pruritus | 2 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Sore Throat | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | COVID-19 | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lightheadedness | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Muscle pain or spasms | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Back Pain | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Bacterial vaginitis | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Increased respiration | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Ulcerative colitis | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lump in armpit | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Constipation | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | AST elevation (Grade 3) | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | ALT elevation | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Seizure | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Scabbing | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pus | 1 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Influenza | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nausea | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Fever | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Painful urination | 0 Participants |
| Group 3: 0.6 mg PUUV - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nerve pain in limb | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Ulcerative colitis | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | COVID-19 | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Muscle pain or spasms | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nausea | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | AST elevation (Grade 3) | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Influenza | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pruritus | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Bacterial vaginitis | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Increased respiration | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nerve pain in limb | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Viral illness/colds | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | ALT elevation | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pus | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Back Pain | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Fever | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Painful urination | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lightheadedness | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Constipation | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Seizure | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Scabbing | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lump in armpit | 0 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Sore Throat | 1 Participants |
| Group 4: 3.0 mg PUUV - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Sore Throat | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pruritus | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Scabbing | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | COVID-19 | 1 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pus | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Increased respiration | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nausea | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Influenza | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Ulcerative colitis | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Constipation | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Bacterial vaginitis | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Muscle pain or spasms | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Painful urination | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | AST elevation (Grade 3) | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Back Pain | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Fever | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Viral illness/colds | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | ALT elevation | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lightheadedness | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nerve pain in limb | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Seizure | 0 Participants |
| Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lump in armpit | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nausea | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Viral illness/colds | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pruritus | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Ulcerative colitis | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nerve pain in limb | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lump in armpit | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Muscle pain or spasms | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Constipation | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | AST elevation (Grade 3) | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lightheadedness | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Painful urination | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | ALT elevation | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Seizure | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | COVID-19 | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Scabbing | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pus | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Influenza | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Sore Throat | 1 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Fever | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Bacterial vaginitis | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Back Pain | 0 Participants |
| Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Increased respiration | 0 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Scabbing | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nausea | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | COVID-19 | 2 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Seizure | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Painful urination | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | ALT elevation | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lightheadedness | 2 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Ulcerative colitis | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | AST elevation (Grade 3) | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Constipation | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Viral illness/colds | 2 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Bacterial vaginitis | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Back Pain | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pruritus | 6 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Fever | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Muscle pain or spasms | 2 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Lump in armpit | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Vomiting | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Sore Throat | 3 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Increased respiration | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Influenza | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Nerve pain in limb | 1 Participants |
| All Groups | Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs) | Pus | 1 Participants |