HIV Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.
Detailed description
This study will evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults. The study will be conducted in three parts (Part A, B and C). Part A will include two groups (Groups 1 and 2), Part B will include four groups (Groups 3, 4, 5, and 6) and Part C will include two groups (Groups 7 and 8). Participants in Part A will be randomly assigned to receive the BG505 SOSIP.664 gp140 vaccine admixed with 3M-052-AF and alum adjuvant or to receive placebo. Part A participants will be enrolled sequentially in Groups 1 and 2 for dose escalation. Participants in Part B will be randomly assigned to Groups 3, 4, 5, or 6, to receive the BG505 SOSIP.664 gp140 vaccine with an adjuvant (the specific adjuvant will vary by group) or to receive placebo. Participants in Part C will be randomly assigned to Groups 7 or 8 to receive: Group 7: The same BG505 SOSIP immunogen but with a lower dose (3mcg) of 3M-052-AF + Alum, Group 8: The Trimer 4571 with 5mcg 3M-052-AF + Alum, or to receive placebo. Participants in Part A will attend 8 months of scheduled clinic visits, and they will be contacted by study staff at Month 14 for follow-up health monitoring. Upon protocol amendment, subjects in Part A were invited to receive a third immunization. Participants in Part B will attend 18 months of scheduled clinic visits. Participants in Part C will attend 18 months of scheduled clinic visits.
Interventions
BIOLOGICALBG505 SOSIP.664 gp140
Administered by IM injection
BIOLOGICALPlacebo
Administered by IM injection
BIOLOGICAL3M-052-AF
Administered by IM injection
BIOLOGICALCpG 1018
Administered by IM injection
BIOLOGICALGLA-LSQ
Administered by IM injection
BIOLOGICALAlum (Aluminum Hydroxide Suspension)
Administered by IM injection
BIOLOGICALTrimer 4571
Administered by IM injection
Sponsors
HIV Vaccine Trials Network
International AIDS Vaccine Initiative
Access to Advanced Health Institute (AAHI)
Dynavax Technologies Corporation
Fred Hutchinson Cancer Center
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
General and Demographic Criteria * Age of 18 through 50 years, inclusive * Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study * Ability and willingness to provide informed consent * Assessment of understanding: volunteer demonstrates understanding of this; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly * Agrees not to enroll in another study of an investigational research agent until after the final study contact. * Good general health as shown by medical history, physical exam, and screening laboratory tests HIV-Related Criteria: * Willingness to receive HIV test results * Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling * Assessed by the clinic staff as being at low risk for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit (see study protocol for more information) Laboratory Inclusion Values Hemogram/Complete blood count (CBC) * Hemoglobin * ≥ 11.0 g/dL for volunteers who were assigned female sex at birth * ≥ 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months * ≥ 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months * For transgender volunteers who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth. * White blood cell count = 2,500 to 12,000 cells/mm\^3 with normal differential, or differential approved by Investigator of Record (IoR) or designee as not clinically significant * Total lymphocyte count ≥ 650 cells/mm\^3 with normal differential, or differential approved by IoR or designee as not clinically significant * Remaining differential either within institutional normal range or with IoR or designee approval * Platelets = 125,000 to 550,000 cells/mm\^3 Chemistry * Alanine aminotransferase (ALT) \< 1.25 times the institutional upper limit of normal * Creatinine \< 1.1 times the institutional upper limit of normal Virology * Negative HIV-1 and -2 blood test: US volunteers must have a negative U.S. Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). * Negative hepatitis B surface antigen (HBsAg) * Negative anti-hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive Urine * Normal urine: * Negative or trace urine protein, and * Negative or trace urine hemoglobin (If trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range,) Reproductive Status * Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test at screening (ie, prior to randomization) and prior to study product administration or any optional study procedure (eg, leukapheresis, fine needle aspirate, bone marrow aspiration, mucosal secretion collection or mucosal biopsy) on the day of study product administration or procedure. Persons who are NOT of reproductive potential due to having undergone hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing. * Reproductive status: A volunteer who was assigned female sex at birth: * Must agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment until 6 months after the final study vaccination. Effective contraception is defined as using the following methods: * Condoms (male or female) with or without a spermicide, * Diaphragm or cervical cap with spermicide, * Intrauterine device (IUD), * Hormonal contraception, * Tubal ligation, or * Any other contraceptive method approved by the HVTN 137 Protocol Safety Review Team (PSRT) * Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a male partner has \[1\] documentation of azoospermia by microscopy, or \[2\] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy); * Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy or bilateral oophorectomy; * Or be sexually abstinent. * Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until 6 months after the last vaccination.
Exclusion criteria
General * Blood products received within 120 days before first vaccination * Investigational research agents received within 30 days before first vaccination * Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: age \> 45, systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg, current smoker, known hyperlipidemia * Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 137 study * Pregnant or breastfeeding * Active duty and reserve US military personnel Vaccines and other Injections * HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 137 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 137 PSRT will determine eligibility on a case-by-case basis * Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 137 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 137 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 year ago, eligibility for enrollment will be determined by the HVTN 137 PSRT on a case-by-case basis. * Live attenuated vaccines received within 30 days before first vaccination or scheduled within 30 days after injection (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine) * Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination or scheduled for 14 days after injection (eg, tetanus, pneumococcal, hepatitis virus A or B) * Previous receipt of HEPLISAV, Shingrix, or RTS,S/AS01B/Mosquirix vaccine received within 30 days prior to first vaccination or scheduled for 30 days after injection. * Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination Immune System * Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatologic condition; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses ≤ 60 mg/day and length of therapy \< 11 days with completion at least 30 days prior to enrollment) * Serious adverse reactions to vaccines or to vaccine components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a non-anaphylactic adverse reaction to pertussis vaccine as a child.) * Immunoglobulin received within 60 days before first vaccination (for mAb see criterion above) * Autoimmune disease, current or history * AESIs: Volunteers who currently have, or have a history of, any condition that could be considered an AESI for the product(s) administered in this protocol (representative examples are listed in the study protocol) * Immunodeficiency Clinically significant medical conditions * Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to: * A process that would affect the immune response, * A process that would require medication that affects the immune response, * Any contraindication to repeated injections or blood draws, * A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period, * A condition or process for which signs or symptoms could be confused with reactions to vaccine, or * Any condition specifically listed among the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented |
| Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented |
| Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6 | Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented |
| Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C) | For each local laboratory measure meeting Grade 1 AE criteria (Mild) or above as specified in the DAIDS AE Grading Table, counts of severity were presented by treatment group and timepoint for the overall population |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | Measured through Month 14 (Part A without second boost) or Month 18 (Part A with second boost, Part B, Part C) | The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm |
| Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Measured through Month 2 (Part A without second boost) or Month 6 (Part A with second boost, Part B, Part C) | The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm |
| Number of Participants With Early Study Termination and Reason for Early Study Termination | Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C) | The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A, Group T1 BG505 SOSIP.664 gp140 & (1 mcg 3M-052-AF + Alum) mo(0,2) | 5 |
| Part A, Group T2 BG505 SOSIP.664 gp140 & (5 mcg 3M-052-AF + Alum) mo(0,2) | 10 |
| Part A, Group C1 Placebo for BG505 SOSIP.664 gp140 & adjuvant mo(0,2) | 2 |
| Part B, Group T3 BG505 SOSIP.664 gp140 & (CpG 1018 + Alum) mo(0,2,6) | 20 |
| Part B, Group T4 BG505 SOSIP.664 gp140 & (3M-052-AF + Alum) mo(0,2,6) | 19 |
| Part B, Group T5 BG505 SOSIP.664 gp140 & GLA-LSQ mo(0,2,6) | 20 |
| Part B, Group T6 BG505 SOSIP.664 gp140 & Alum mo(0,2,6) | 20 |
| Part B, Group C2 Placebo for BG505 SOSIP.664 gp140 & adjuvant mo(0,2,6) | 9 |
| Part C, Group T7 BG505 SOSIP.664 gp140 & (3mcg 3M-052-AF+Alum) mo(0,2,6) | 10 |
| Part C, Group T8 Trimer 4571 & (5mcg 3M-052-AF+Alum) mo(0,2,6) | 10 |
| Part C, Group C3 Placebo for BG505 SOSIP.664 gp140/Trimer 4571 & adjuvant mo(0,2,6) | 2 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 | 0 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part A, Group T1 | Part A, Group T2 | Part A, Group C1 | Part B, Group T3 | Part B, Group T4 | Part B, Group T5 | Part B, Group T6 | Part B, Group C2 | Part C, Group T7 | Part C, Group T8 | Part C, Group C3 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 29 years | 28 years | 25.5 years | 23.5 years | 28 years | 32 years | 28 years | 26.5 years | 33 years | 30 years | 36 years | 44 years |
| Age, Customized 18-20 years | 9 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 21-30 years | 64 Participants | 4 Participants | 7 Participants | 2 Participants | 12 Participants | 7 Participants | 10 Participants | 10 Participants | 3 Participants | 5 Participants | 4 Participants | 0 Participants |
| Age, Customized 31-40 years | 36 Participants | 1 Participants | 2 Participants | 0 Participants | 7 Participants | 6 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 5 Participants | 0 Participants |
| Age, Customized 41-50 years | 18 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 3 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized Above 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Less than 18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 3 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 114 Participants | 5 Participants | 9 Participants | 1 Participants | 19 Participants | 16 Participants | 18 Participants | 17 Participants | 9 Participants | 9 Participants | 9 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 1 Participants | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 16 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 93 Participants | 3 Participants | 8 Participants | 1 Participants | 16 Participants | 12 Participants | 18 Participants | 16 Participants | 9 Participants | 5 Participants | 5 Participants | 0 Participants |
| Region of Enrollment USA | 127 Participants | 5 Participants | 10 Participants | 2 Participants | 20 Participants | 19 Participants | 20 Participants | 20 Participants | 9 Participants | 10 Participants | 10 Participants | 2 Participants |
| Sex: Female, Male Female | 71 Participants | 4 Participants | 6 Participants | 2 Participants | 13 Participants | 9 Participants | 12 Participants | 8 Participants | 3 Participants | 7 Participants | 6 Participants | 1 Participants |
| Sex: Female, Male Male | 56 Participants | 1 Participants | 4 Participants | 0 Participants | 7 Participants | 10 Participants | 8 Participants | 12 Participants | 6 Participants | 3 Participants | 4 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 10 | 0 / 2 | 0 / 20 | 0 / 19 | 0 / 20 | 0 / 20 | 0 / 9 | 0 / 10 | 0 / 10 | 0 / 2 |
| other Total, other adverse events | 5 / 5 | 10 / 10 | 1 / 2 | 19 / 20 | 19 / 19 | 20 / 20 | 20 / 20 | 9 / 9 | 10 / 10 | 10 / 10 | 1 / 2 |
| serious Total, serious adverse events | 1 / 5 | 0 / 10 | 0 / 2 | 1 / 20 | 0 / 19 | 1 / 20 | 0 / 20 | 0 / 9 | 0 / 10 | 0 / 10 | 0 / 2 |
Outcome results
Primary
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Time frame: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Population: Started (enrolled).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 4 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 5 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 4 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 2 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 2 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 2 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 8 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 8 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 8 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 19 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 19 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 20 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 1 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 1 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 16 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 2 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 16 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 2 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 19 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 20 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 20 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 20 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 1 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 19 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 20 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 19 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 9 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 9 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 9 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 1 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 9 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 9 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 9 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 9 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 9 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 10 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Mild | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 2 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Mild | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 2 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Potentially Life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Potentially Life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Potentially Life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 2 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Mild | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Moderate | 0 Participants |
Primary
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Time frame: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Population: Started (enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 4 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 4 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 6 Participants |
| Part A, Group T2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 1 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 1 Participants |
| Part A, Group C1 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 5 Participants |
| Part B, Group T3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 14 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 7 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 12 Participants |
| Part B, Group T4 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 4 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 15 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 19 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 1 Participants |
| Part B, Group T6 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 4 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 5 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 4 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 6 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 6 Participants |
| Part C, Group T8 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 4 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Mild | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | None | 2 Participants |
| Part C, Group C3 | Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
Primary
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented
Time frame: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Population: Started (enrolled).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 2 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 3 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 2 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 3 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 2 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 3 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 2 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 2 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 2 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 2 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 2 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 3 Participants |
| Part A, Group T1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 6 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 1 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 2 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 3 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 3 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 1 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 3 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 2 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 1 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 5 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 4 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 6 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 5 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 5 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 3 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 3 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 4 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 4 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 5 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 1 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 3 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 1 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 5 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 2 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 2 Participants |
| Part A, Group C1 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 2 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 2 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 16 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 10 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 6 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 17 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 3 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 18 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 10 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 17 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 10 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 2 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 11 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 3 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 20 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 6 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 4 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 9 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 3 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 3 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 8 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 6 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 2 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 5 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 6 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 7 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 4 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 9 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 5 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 3 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 11 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 4 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 1 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 1 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 9 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 5 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 4 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 2 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 5 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 10 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 2 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 2 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 12 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 5 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 7 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 11 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 4 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 3 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 5 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 20 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 10 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 3 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 5 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 12 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 14 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 6 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 6 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 3 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 16 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 13 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 2 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 17 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 4 Participants |
| Part B, Group T5 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 2 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 4 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 20 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 7 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 4 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 9 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 4 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 16 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 15 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 5 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 15 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 1 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 19 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 10 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 7 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 3 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 6 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 10 Participants |
| Part B, Group T6 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 5 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 6 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 7 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 9 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 1 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 3 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 6 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 2 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 9 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 9 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 4 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 5 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 3 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 8 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 2 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 2 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 6 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 2 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 5 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 1 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 4 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 2 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 3 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 5 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 6 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 3 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 2 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 2 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 4 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 8 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 5 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 3 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 3 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 1 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 1 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 5 Participants |
| Part C, Group T7 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 5 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 7 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 2 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 4 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 3 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 7 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 2 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 3 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 4 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 5 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 5 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 2 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 2 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 5 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 2 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 8 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 2 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 1 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | None | 2 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | None | 2 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | None | 1 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Mild | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Mild | 1 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | None | 2 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | None | 2 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | None | 2 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | None | 2 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Chills | Mild | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Headache | Mild | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Mild | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Mild | 1 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Temperature | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
Primary
Number of Participants Reporting Unsolicited Adverse Events (AEs)
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm
Time frame: Measured through Month 14 (Part A without second boost) or Month 18 (Part A with second boost, Part B, Part C)
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group T1 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Part A, Group T1 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 1 Participants |
| Part A, Group T1 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 2 Participants |
| Part A, Group T2 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 3 Participants |
| Part A, Group T2 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Part A, Group T2 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 4 Participants |
| Part A, Group T2 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 1 Participants |
| Part A, Group C1 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 1 Participants |
| Part A, Group C1 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Part A, Group C1 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 11 Participants |
| Part B, Group T3 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 4 Participants |
| Part B, Group T3 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 0 Participants |
| Part B, Group T3 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 1 Participants |
| Part B, Group T4 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 6 Participants |
| Part B, Group T4 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 8 Participants |
| Part B, Group T4 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Part B, Group T4 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 1 Participants |
| Part B, Group T5 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Part B, Group T5 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 5 Participants |
| Part B, Group T5 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 9 Participants |
| Part B, Group T5 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 2 Participants |
| Part B, Group T6 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 3 Participants |
| Part B, Group T6 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Part B, Group T6 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 3 Participants |
| Part B, Group T6 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 11 Participants |
| Part B, Group C2 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 4 Participants |
| Part B, Group C2 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Part B, Group C2 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 3 Participants |
| Part C, Group T7 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 3 Participants |
| Part C, Group T7 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 0 Participants |
| Part C, Group T7 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 6 Participants |
| Part C, Group T8 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 0 Participants |
| Part C, Group T8 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 5 Participants |
| Part C, Group T8 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 1 Participants |
| Part C, Group T8 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Moderate | 1 Participants |
| Part C, Group C3 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Potentially life-threatening | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Severe | 0 Participants |
| Part C, Group C3 | Number of Participants Reporting Unsolicited Adverse Events (AEs) | Mild | 0 Participants |
Primary
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Time frame: Measured through Month 2 (Part A without second boost) or Month 6 (Part A with second boost, Part B, Part C)
Population: Started (enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group T1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 0 Participants |
| Part A, Group T1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 4 Participants |
| Part A, Group T1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 1 Participants |
| Part A, Group T1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 0 Participants |
| Part A, Group T1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 0 Participants |
| Part A, Group T1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 0 Participants |
| Part A, Group T1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 0 Participants |
| Part A, Group T1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 0 Participants |
| Part A, Group T1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 0 Participants |
| Part A, Group T2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 1 Participants |
| Part A, Group T2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 0 Participants |
| Part A, Group T2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 9 Participants |
| Part A, Group T2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Part A, Group T2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 0 Participants |
| Part A, Group T2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 0 Participants |
| Part A, Group T2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 0 Participants |
| Part A, Group T2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 0 Participants |
| Part A, Group T2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 2 Participants |
| Part A, Group C1 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 0 Participants |
| Part B, Group T3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 0 Participants |
| Part B, Group T3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 0 Participants |
| Part B, Group T3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 19 Participants |
| Part B, Group T3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 0 Participants |
| Part B, Group T3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 1 Participants |
| Part B, Group T3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 0 Participants |
| Part B, Group T3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 0 Participants |
| Part B, Group T3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 0 Participants |
| Part B, Group T3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Part B, Group T4 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 2 Participants |
| Part B, Group T4 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 1 Participants |
| Part B, Group T4 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 1 Participants |
| Part B, Group T4 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 0 Participants |
| Part B, Group T4 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 0 Participants |
| Part B, Group T4 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 0 Participants |
| Part B, Group T4 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 0 Participants |
| Part B, Group T4 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Part B, Group T4 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 15 Participants |
| Part B, Group T5 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 0 Participants |
| Part B, Group T5 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 0 Participants |
| Part B, Group T5 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Part B, Group T5 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 0 Participants |
| Part B, Group T5 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 0 Participants |
| Part B, Group T5 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 0 Participants |
| Part B, Group T5 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 0 Participants |
| Part B, Group T5 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 0 Participants |
| Part B, Group T5 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 20 Participants |
| Part B, Group T6 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 0 Participants |
| Part B, Group T6 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Part B, Group T6 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 0 Participants |
| Part B, Group T6 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 19 Participants |
| Part B, Group T6 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 0 Participants |
| Part B, Group T6 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 0 Participants |
| Part B, Group T6 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 0 Participants |
| Part B, Group T6 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 1 Participants |
| Part B, Group T6 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 9 Participants |
| Part B, Group C2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 0 Participants |
| Part C, Group T7 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 0 Participants |
| Part C, Group T7 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 1 Participants |
| Part C, Group T7 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 0 Participants |
| Part C, Group T7 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 0 Participants |
| Part C, Group T7 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 0 Participants |
| Part C, Group T7 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 0 Participants |
| Part C, Group T7 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Part C, Group T7 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 1 Participants |
| Part C, Group T7 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 8 Participants |
| Part C, Group T8 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 0 Participants |
| Part C, Group T8 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 0 Participants |
| Part C, Group T8 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 0 Participants |
| Part C, Group T8 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 1 Participants |
| Part C, Group T8 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Part C, Group T8 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 9 Participants |
| Part C, Group T8 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 0 Participants |
| Part C, Group T8 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 0 Participants |
| Part C, Group T8 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 0 Participants |
| Part C, Group C3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Relocated, however participant agreed to continued follow-up with phone calls | 0 Participants |
| Part C, Group C3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Investigator decision | 0 Participants |
| Part C, Group C3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Solicited adverse event | 0 Participants |
| Part C, Group C3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Did not discontinue SPA | 2 Participants |
| Part C, Group C3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant refused study product administration | 0 Participants |
| Part C, Group C3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Participant unable to adhere to visit schedule | 0 Participants |
| Part C, Group C3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Unsolicited adverse event | 0 Participants |
| Part C, Group C3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Withdrawal by Subject | 0 Participants |
| Part C, Group C3 | Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation | Lost to Follow-Up | 0 Participants |
Primary
Number of Participants With Early Study Termination and Reason for Early Study Termination
The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
Time frame: Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C)
Population: Started (enrolled).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group T1 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 0 Participants |
| Part A, Group T1 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 5 Participants |
| Part A, Group T1 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 0 Participants |
| Part A, Group T1 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 0 Participants |
| Part A, Group T2 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 1 Participants |
| Part A, Group T2 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 1 Participants |
| Part A, Group T2 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 8 Participants |
| Part A, Group T2 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 2 Participants |
| Part A, Group C1 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 0 Participants |
| Part A, Group C1 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 0 Participants |
| Part B, Group T3 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 0 Participants |
| Part B, Group T3 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 1 Participants |
| Part B, Group T3 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 18 Participants |
| Part B, Group T3 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 1 Participants |
| Part B, Group T4 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 16 Participants |
| Part B, Group T4 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 1 Participants |
| Part B, Group T4 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 1 Participants |
| Part B, Group T4 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 1 Participants |
| Part B, Group T5 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 20 Participants |
| Part B, Group T5 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 0 Participants |
| Part B, Group T5 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 0 Participants |
| Part B, Group T5 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 0 Participants |
| Part B, Group T6 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 1 Participants |
| Part B, Group T6 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 19 Participants |
| Part B, Group T6 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 0 Participants |
| Part B, Group T6 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 0 Participants |
| Part B, Group C2 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 9 Participants |
| Part B, Group C2 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 0 Participants |
| Part C, Group T7 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 1 Participants |
| Part C, Group T7 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 9 Participants |
| Part C, Group T7 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 0 Participants |
| Part C, Group T7 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 0 Participants |
| Part C, Group T8 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 0 Participants |
| Part C, Group T8 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 0 Participants |
| Part C, Group T8 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 0 Participants |
| Part C, Group T8 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 10 Participants |
| Part C, Group C3 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Unable to contact participant | 0 Participants |
| Part C, Group C3 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Scheduled exit visit/end of study | 2 Participants |
| Part C, Group C3 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant relocated, no follow-up planned | 0 Participants |
| Part C, Group C3 | Number of Participants With Early Study Termination and Reason for Early Study Termination | Participant refused further participation | 0 Participants |
Primary
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
For each local laboratory measure meeting Grade 1 AE criteria (Mild) or above as specified in the DAIDS AE Grading Table, counts of severity were presented by treatment group and timepoint for the overall population
Time frame: Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C)
Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A, Group T1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 0 Participants |
| Part A, Group T1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 0 Participants |
| Part A, Group T1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 0 Participants |
| Part A, Group T1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 0 Participants |
| Part A, Group T1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 0 Participants |
| Part A, Group T1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 1 Participants |
| Part A, Group T1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 0 Participants |
| Part A, Group T1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 0 Participants |
| Part A, Group T1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 2 Participants |
| Part A, Group T1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 1 Participants |
| Part A, Group T2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 1 Participants |
| Part A, Group T2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 0 Participants |
| Part A, Group T2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 0 Participants |
| Part A, Group T2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 0 Participants |
| Part A, Group T2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 0 Participants |
| Part A, Group T2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 0 Participants |
| Part A, Group T2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 0 Participants |
| Part A, Group T2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 0 Participants |
| Part A, Group T2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 0 Participants |
| Part A, Group T2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 0 Participants |
| Part A, Group C1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 0 Participants |
| Part A, Group C1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 0 Participants |
| Part A, Group C1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 0 Participants |
| Part A, Group C1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 0 Participants |
| Part A, Group C1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 0 Participants |
| Part A, Group C1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 0 Participants |
| Part A, Group C1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 0 Participants |
| Part A, Group C1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 0 Participants |
| Part A, Group C1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 0 Participants |
| Part A, Group C1 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 0 Participants |
| Part B, Group T3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 0 Participants |
| Part B, Group T3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 0 Participants |
| Part B, Group T3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 0 Participants |
| Part B, Group T3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 0 Participants |
| Part B, Group T3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 0 Participants |
| Part B, Group T3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 0 Participants |
| Part B, Group T3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 1 Participants |
| Part B, Group T3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 0 Participants |
| Part B, Group T3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 0 Participants |
| Part B, Group T3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 0 Participants |
| Part B, Group T4 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 1 Participants |
| Part B, Group T4 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 0 Participants |
| Part B, Group T4 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 0 Participants |
| Part B, Group T4 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 1 Participants |
| Part B, Group T4 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 0 Participants |
| Part B, Group T4 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 1 Participants |
| Part B, Group T4 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 0 Participants |
| Part B, Group T4 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 0 Participants |
| Part B, Group T4 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 0 Participants |
| Part B, Group T4 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 1 Participants |
| Part B, Group T5 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 0 Participants |
| Part B, Group T5 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 0 Participants |
| Part B, Group T5 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 0 Participants |
| Part B, Group T5 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 0 Participants |
| Part B, Group T5 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 0 Participants |
| Part B, Group T5 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 0 Participants |
| Part B, Group T5 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 1 Participants |
| Part B, Group T5 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 0 Participants |
| Part B, Group T5 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 1 Participants |
| Part B, Group T5 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 0 Participants |
| Part B, Group T6 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 2 Participants |
| Part B, Group T6 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 0 Participants |
| Part B, Group T6 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 0 Participants |
| Part B, Group T6 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 0 Participants |
| Part B, Group T6 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 1 Participants |
| Part B, Group T6 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 0 Participants |
| Part B, Group T6 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 0 Participants |
| Part B, Group T6 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 0 Participants |
| Part B, Group T6 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 1 Participants |
| Part B, Group T6 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 0 Participants |
| Part B, Group C2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 1 Participants |
| Part B, Group C2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 0 Participants |
| Part B, Group C2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 0 Participants |
| Part B, Group C2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 0 Participants |
| Part B, Group C2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 0 Participants |
| Part B, Group C2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 0 Participants |
| Part B, Group C2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 1 Participants |
| Part B, Group C2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 0 Participants |
| Part B, Group C2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 0 Participants |
| Part B, Group C2 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 0 Participants |
| Part C, Group T7 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 0 Participants |
| Part C, Group T7 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 0 Participants |
| Part C, Group T7 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 0 Participants |
| Part C, Group T7 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 0 Participants |
| Part C, Group T7 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 0 Participants |
| Part C, Group T7 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 0 Participants |
| Part C, Group T7 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 0 Participants |
| Part C, Group T7 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 0 Participants |
| Part C, Group T7 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 0 Participants |
| Part C, Group T7 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 0 Participants |
| Part C, Group T8 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 1 Participants |
| Part C, Group T8 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 0 Participants |
| Part C, Group T8 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 0 Participants |
| Part C, Group T8 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 0 Participants |
| Part C, Group T8 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 0 Participants |
| Part C, Group T8 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 0 Participants |
| Part C, Group T8 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 0 Participants |
| Part C, Group T8 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 0 Participants |
| Part C, Group T8 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 0 Participants |
| Part C, Group T8 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 0 Participants |
| Part C, Group C3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 14 | 0 Participants |
| Part C, Group C3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 364 | 0 Participants |
| Part C, Group C3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 182 | 0 Participants |
| Part C, Group C3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Hemoglobin (g/dL)- Day 364 | 0 Participants |
| Part C, Group C3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 14 | 0 Participants |
| Part C, Group C3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 70 | 0 Participants |
| Part C, Group C3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 182 | 0 Participants |
| Part C, Group C3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | ALT (SGPT) (U/L)- Day 364 | 0 Participants |
| Part C, Group C3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Neutrophils (1000 cells/cubic mm)- Day 14 | 0 Participants |
| Part C, Group C3 | Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above | Creatinine (mg/dL)- Day 70 | 0 Participants |