HIV Infections
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults.
Detailed description
This study will evaluate the safety, tolerability, and serum concentrations of a human monoclonal antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), administered in multiple doses and routes to healthy, HIV-uninfected adults. Participants will be randomly assigned to one of six groups. Participants in Group 1 will receive 2.5 mg/kg of VRC07-523LS by intravenous (IV) infusion at Weeks 0, 16, 32, 48, and 64. Participants in Group 2 will receive 5 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 16, 32, 48, and 64. Participants in Group 3 will receive 20 mg/kg of VRC07-523LS by IV infusion at Weeks 0, 16, 32, 48, and 64. Participants in Group 4 will receive 2.5 mg/kg of VRC07-523LS by subcutaneous (SC) injection at Weeks 0, 16, 32, 48, and 64. Participants in Group 5 will receive 5 mg/kg of VRC07-523LS by SC injection at Weeks 0, 16, 32, 48, and 64. Participants in Group 6 will receive 2.5 mg/kg of VRC07-523LS or placebo by intramuscular (IM) injection at Weeks 0, 16, 32, 48, and 64. Participants will attend numerous study visits throughout the course of the study, beginning at Week 0 through Week 112. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires.
Interventions
BIOLOGICALVRC07-523LS
Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in
BIOLOGICALPlacebo
Sodium Chloride for Injection USP, 0.9%; administered by IM injection
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
General and Demographic Criteria * Age of 18 to 50 years * Access to a participating 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 study and completes a questionnaire prior to first study product administration with verbal demonstration of understanding of all questionnaire items answered incorrectly * Agrees not to enroll in another study of an investigational research agent until completion of the last required protocol clinic visit * 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 those criteria through the last required protocol clinic visit (see the protocol for more information). Laboratory Inclusion Values Hemogram/Complete Blood Count (CBC) * Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for volunteers assigned female sex at birth). * White blood cell (WBC) count equal to 2,500 to 12,000 cells/mm\^3 * WBC differential either within institutional normal range or with site physician approval * Platelets equal to 125,000 to 550,000/mm\^3 Chemistry * Chemistry panel: Alanine aminotransferase (ALT) less than 1.25 times the institutional upper limit of normal and creatinine less than or equal to institutional upper limits of normal. Virology * Negative HIV-1 and -2 blood test: US volunteers must have a negative US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA). Non-US sites may use locally available assays that have been approved by HVTN and HIV Prevention Trials Network (HPTN) Laboratory Operations. * 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 * Negative or trace urine protein Reproductive Status * Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test performed prior to study product administration on the day of initial study infusion/injection. Persons who are NOT of reproductive potential due to having undergone total 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 (see protocol for more information) for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit. 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, or * Any other contraceptive method approved by the HVTN 127/HPTN 087 Protocol Safety Review Team (PSRT) * Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a partner assigned male sex at birth 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, bilateral oophorectomy, or tubal ligation; * Or plan to be sexually abstinent until at least 6 months following the last study product administration. * 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 after the last required protocol clinic visit
Exclusion criteria
General * Weight greater than 115 kg * Blood products received within 120 days before first study product administration, unless eligibility for earlier enrollment is determined by the HVTN 127/HPTN 087 PSRT * Investigational research agents received within 30 days before first study product administration * Intent to participate in another study of an investigational research agent or any other study that requires non-Network HIV antibody testing during the planned duration of the HVTN 127/HPTN 087 study * Pregnant or breastfeeding 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 127/HPTN 087 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of humanized or human mAbs, whether licensed or investigational; the HVTN 127/HPTN 087 PSRT will determine eligibility on a case-by-case basis. * Previous receipt of monoclonal antibodies VRC01, VRC01LS, or VRC07-523LS Immune System * Immunosuppressive medications received within 30 days before first injection or infusion (Not exclusionary: \[1\] corticosteroid nasal spray; \[2\] inhaled corticosteroids; \[3\] topical corticosteroids for mild, uncomplicated dermatitis; or \[4\] a single course of oral/parenteral prednisone or equivalent at doses less than 2 mg/kg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment) * Serious adverse reactions to VRC07-523LS formulation components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain * Immunoglobulin received within 90 days before first injection or infusion, unless eligibility for earlier enrollment is determined by the HVTN 127/HPTN 087 PSRT * Autoimmune disease (Not excluded from participation: Volunteer with mild, stable and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate Solicited and Unsolicited adverse event (AE) assessments) * 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, infusions, or blood draws, including inability to establish venous access, * 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 (eg, chronic urticaria or recent injection or infusion with evidence of residual inflammation) for which signs or symptoms could be confused with reactions to the study product, or * Any condition specifically listed among the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VRC07523LS Serum Concentrations | Target Visit Days 0, 3, 6, 28, 56, 84, 112, 168, 224, 280, 336, 392, 448, 504, 560, 616, 672, 728, 784 (i.e., visit numbers 2 through 20) | VRC07523LS serum concentrations measured in healthy human subjects after up to five administrations of the study product via the IV, SC or IM routes at various doses. Serum concentrations between the first and second study product administrations (Target Visit Day 0-112) were measured using ELISA assay in all enrolled participants. Serum concentrations after the second study product administrations (Target Visit Day 168-784) were measured using BAMA (LUMINEX) assay in a subset of participants enrolled in each treatment group and all particiants in plocebo group. serum concentrations below the lower limit of quantification (LLoQ) were replaced by half the LLoQ. Thus, concentrations below the LLoQ when measured by the ELISA assay were replaced by 0.5 ug/ml and concentrations below the LLoQ when measured by the BAMA assay were replaced by 0.02285 ug/ml. |
| Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728 | The number (percentage) of participants with lab grade \>= 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm |
| Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64 | 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 Reactogenicity Signs and Symptoms: Erythema and/or Induration | Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64 | 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 Reactogenicity Signs and Symptoms | Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64 | 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 following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant. |
| Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Creatinine | Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Hemoglobin | Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
| Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728 | For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | Weeks 8, 72, and 88 following the first study product administration | Magnitude-breadth characterize the magnitude (ID50 or ID80 titers) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the fraction of assays with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) is calculated as the average of the log10-based ID50 or ID80 titers over the panel of isolates. Isolates includes: H703\_0646\_051sN, H703\_1471\_190s, H703\_1750\_140Es, H704\_0726\_080sN, H704\_1535\_030sN, H704\_2544\_140eN01, PVO.4. |
| Occurrence of Antidrug Antibodies (ADA) | Day 0, 6, 112, 224, 448 | Antidrug antibodies (ADA) are most typically detected and characterized using a tiered testing strategy. In Tier I, a sensitive binding assay is used to determine if samples may have ADA present. In Tier II, the response is confirmed, typically by establishing the specificity of the response by competition with free drug. In Tier III, the response is characterized, typically with a neutralization reduction assay and/or a titering assay. |
Countries
Switzerland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Vaccine VRC07-523LS IV-2.5 mg/kg wks(0,16,32,48,64) | 19 |
| Group 2: Vaccine VRC07-523LS IV-5 mg/kg wks(0,16,32,48,64) | 19 |
| Group 3: Vaccine VRC07-523LS IV-20 mg/kg wks(0,16,32,48,64) | 21 |
| Group 4: Vaccine VRC07-523LS SC-2.5 mg/kg wks(0,16,32,48,64) | 21 |
| Group 5: Vaccine VRC07-523LS SC-5 mg/kg wks(0,16,32,48,64) | 20 |
| Group 6: Vaccine VRC07-523LS IM-2.5 mg/kg wks(0,16,32,48,64) | 21 |
| Group 7: Placebo IM-0.9% Sodium Chloride wks(0,16,32,48,64) | 3 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 2 | 3 | 3 | 3 | 0 |
| Overall Study | Participant unable to adhere to visit | 0 | 1 | 0 | 0 | 2 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 3 | 4 | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Group 2: Vaccine | Group 3: Vaccine | Group 1: Vaccine | Group 4: Vaccine | Group 5: Vaccine | Group 6: Vaccine | Group 7: Placebo |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 28 years | 30 years | 23 years | 30 years | 29 years | 27 years | 27 years | 31 years |
| Age, Customized 18 - 20 years | 14 Participants | 3 Participants | 4 Participants | 4 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants |
| Age, Customized 21 - 30 years | 66 Participants | 7 Participants | 11 Participants | 6 Participants | 11 Participants | 17 Participants | 13 Participants | 1 Participants |
| Age, Customized 31 - 40 years | 28 Participants | 7 Participants | 4 Participants | 6 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants |
| Age, Customized 41 - 50 years | 16 Participants | 2 Participants | 2 Participants | 3 Participants | 6 Participants | 0 Participants | 3 Participants | 0 Participants |
| Age, Customized Above 50 years | 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 |
| Age, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 3 Participants | 5 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 112 Participants | 16 Participants | 16 Participants | 19 Participants | 19 Participants | 20 Participants | 19 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 4 Participants | 2 Participants | 5 Participants | 5 Participants | 6 Participants | 6 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 2 Participants | 1 Participants | 2 Participants | 3 Participants | 2 Participants | 1 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 |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 2 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 71 Participants | 10 Participants | 13 Participants | 12 Participants | 10 Participants | 11 Participants | 12 Participants | 3 Participants |
| Region of Enrollment USA | 124 Participants | 19 Participants | 21 Participants | 19 Participants | 21 Participants | 20 Participants | 21 Participants | 3 Participants |
| Sex: Female, Male Female | 75 Participants | 8 Participants | 11 Participants | 14 Participants | 15 Participants | 13 Participants | 11 Participants | 3 Participants |
| Sex: Female, Male Male | 49 Participants | 11 Participants | 10 Participants | 5 Participants | 6 Participants | 7 Participants | 10 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 19 | 0 / 21 | 0 / 21 | 0 / 20 | 0 / 21 | 0 / 3 |
| other Total, other adverse events | 14 / 19 | 16 / 19 | 14 / 21 | 18 / 21 | 16 / 20 | 17 / 21 | 3 / 3 |
| serious Total, serious adverse events | 1 / 19 | 1 / 19 | 0 / 21 | 1 / 21 | 0 / 20 | 0 / 21 | 0 / 3 |
Outcome results
Primary
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT)
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728
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 (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 224 | 18 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 728 | 19 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 336 | 15 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 280 | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 0/Enrollment | 14 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Screening | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 56 | 15 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 504 | 12 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 112 | 16 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 448 | 13 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 168 | 13.5 U/L |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 392 | 17 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Screening | 16 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 728 | 16 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 56 | 16 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 448 | 16.5 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 224 | 17 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 280 | 18 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 392 | 16 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 336 | 17 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 0/Enrollment | 16 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 112 | 20 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 504 | 15 U/L |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 168 | 14.5 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 728 | 16 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 168 | 15 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 56 | 15 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 448 | 17.5 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 112 | 13 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 504 | 13.5 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 224 | 15.5 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 336 | 14.5 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 392 | 19 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 280 | 15 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 0/Enrollment | 19 U/L |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Screening | 16 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 504 | 14.5 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Screening | 14 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 0/Enrollment | 13.5 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 56 | 13 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 112 | 12 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 168 | 14 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 224 | 13 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 280 | 15 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 336 | 15 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 392 | 15 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 448 | 16 U/L |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 728 | 18.5 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 392 | 16 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Screening | 18 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 56 | 15 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 112 | 16 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 448 | 18 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 336 | 16 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 280 | 17 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 504 | 16.5 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 168 | 16.5 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 0/Enrollment | 13 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 224 | 14 U/L |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 728 | 18 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 280 | 14 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 168 | 15 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 336 | 15 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 112 | 14 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 392 | 15 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 56 | 13 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 728 | 14 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 448 | 13 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 0/Enrollment | 12 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 504 | 17 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Screening | 13 U/L |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 224 | 14.5 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 280 | 18 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 112 | 19 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 336 | 13 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 728 | 26 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 504 | 15 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- Screening | 13 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 168 | 19 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 56 | 31 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 224 | 17 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 448 | 16 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 392 | 18 U/L |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) | ALT (SGPT) (U/L)- 0/Enrollment | 17 U/L |
Primary
Chemistry and Hematology Laboratory Measures - Creatinine
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728
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 (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 728 | 1.1 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Screening | 0.85 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 56 | 0.84 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 168 | 0.86 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 504 | 0.87 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 224 | 0.79 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 280 | 0.81 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 0/Enrollment | 0.8 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 392 | 0.88 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 448 | 0.82 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 112 | 0.8 mg/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 336 | 0.84 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 504 | 0.92 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 280 | 0.89 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 0/Enrollment | 0.93 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 728 | 1.1 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 56 | 0.9 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Screening | 0.92 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 224 | 0.86 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 112 | 0.88 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 392 | 0.95 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 448 | 0.9 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 168 | 0.91 mg/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 336 | 0.85 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 392 | 0.82 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 448 | 0.8 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 336 | 0.85 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 0/Enrollment | 0.83 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 280 | 0.78 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 224 | 0.81 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 168 | 0.81 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 56 | 0.94 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 504 | 0.78 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Screening | 0.84 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 728 | 0.77 mg/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 112 | 0.88 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 448 | 0.81 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Screening | 0.79 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 0/Enrollment | 0.83 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 56 | 0.82 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 112 | 0.86 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 168 | 0.83 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 224 | 0.81 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 280 | 0.81 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 336 | 0.84 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 392 | 0.85 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 504 | 0.85 mg/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 728 | 0.87 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 504 | 0.8 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 392 | 0.89 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 0/Enrollment | 0.8 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Screening | 0.84 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 728 | 0.81 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 224 | 0.83 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 280 | 0.85 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 336 | 0.87 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 112 | 0.79 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 448 | 0.9 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 168 | 0.81 mg/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 56 | 0.82 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 56 | 0.8 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 112 | 0.84 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 0/Enrollment | 0.83 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 504 | 0.88 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 392 | 0.89 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 336 | 0.87 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 168 | 0.9 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 448 | 0.84 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 224 | 0.82 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 728 | 0.89 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Screening | 0.86 mg/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 280 | 0.89 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 448 | 0.75 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 168 | 0.7 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 728 | 0.66 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 336 | 0.78 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 392 | 0.75 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 112 | 0.72 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 56 | 0.7 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 280 | 0.72 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 0/Enrollment | 0.77 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 504 | 0.81 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- Screening | 0.74 mg/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Creatinine | Creatinine (mg/dL)- 224 | 0.72 mg/dL |
Primary
Chemistry and Hematology Laboratory Measures - Hemoglobin
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728
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 (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 224 | 12.95 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 728 | 12.7 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 336 | 13.3 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 280 | 13.3 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 0/Enrollment | 13.1 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 13.3 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 56 | 13.35 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 504 | 13.25 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 112 | 12.7 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 448 | 12.9 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 168 | 13.7 g/dL |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 392 | 13.3 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 14.2 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 728 | 14.7 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 56 | 14.25 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 448 | 13.95 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 224 | 13.7 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 280 | 13.7 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 392 | 14.2 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 336 | 13.6 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 0/Enrollment | 13.9 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 112 | 13.95 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 504 | 14.35 g/dL |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 168 | 14.1 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 728 | 13.1 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 168 | 13.65 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 56 | 13.4 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 448 | 13.3 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 112 | 13.6 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 504 | 13.4 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 224 | 13.2 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 336 | 13.3 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 392 | 13.5 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 280 | 13.1 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 0/Enrollment | 13.8 g/dL |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 13.8 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 504 | 13 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 13.1 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 0/Enrollment | 13 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 56 | 12.9 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 112 | 13.1 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 168 | 13.25 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 224 | 13.5 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 280 | 13.3 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 336 | 13.3 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 392 | 13.4 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 448 | 13.3 g/dL |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 728 | 14.9 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 392 | 13.5 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 13.8 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 56 | 13.8 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 112 | 13.7 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 448 | 13.6 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 336 | 13.5 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 280 | 13.6 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 504 | 13.9 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 168 | 13.5 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 0/Enrollment | 13.55 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 224 | 13.6 g/dL |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 728 | 14.6 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 280 | 14.2 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 168 | 14.5 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 336 | 14.2 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 112 | 14.45 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 392 | 14.3 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 56 | 14.4 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 728 | 14 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 448 | 14.2 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 0/Enrollment | 14.1 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 504 | 14.4 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 14.4 g/dL |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 224 | 14.15 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 280 | 13.3 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 112 | 12.6 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 336 | 12.9 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 728 | 12.5 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 504 | 12.9 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- Screening | 13.4 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 168 | 12.8 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 56 | 12.6 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 224 | 13.1 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 448 | 13 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 392 | 12.6 g/dL |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Hemoglobin | Hemoglobin (g/dL)- 0/Enrollment | 12.5 g/dL |
Primary
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728
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 (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 280 | 2.69 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 0/Enrollment | 2.95 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 56 | 3.12 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 112 | 3.65 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 168 | 3.35 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 224 | 2.94 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- Screening | 3.84 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 336 | 3.06 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 392 | 3.13 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 448 | 3.11 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 504 | 3.38 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 728 | 4.56 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- Screening | 2 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 0/Enrollment | 1.86 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 112 | 1.82 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 168 | 1.76 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 224 | 1.65 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 280 | 1.93 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 336 | 2 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 392 | 1.79 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 448 | 1.89 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 504 | 1.92 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 728 | 1.85 1000 cells /cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 56 | 1.98 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 224 | 3.55 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 56 | 3.83 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 336 | 3.55 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 728 | 4.25 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 168 | 3.1 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 336 | 1.69 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 112 | 3.87 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 280 | 1.71 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- Screening | 3.7 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 392 | 3.61 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 0/Enrollment | 1.85 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 448 | 1.83 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 224 | 1.91 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 0/Enrollment | 4.01 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 168 | 1.8 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 280 | 3.64 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 448 | 3.76 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 728 | 1.7 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- Screening | 1.98 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 112 | 1.8 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 504 | 1.89 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 56 | 1.94 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 392 | 1.8 1000 cells /cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 504 | 3.86 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 448 | 3.74 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 0/Enrollment | 3.92 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 728 | 2.24 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- Screening | 2.04 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 728 | 4.02 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- Screening | 3.72 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 224 | 3.53 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 448 | 1.96 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 504 | 1.84 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 280 | 3.57 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 56 | 4 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 392 | 2.01 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 336 | 2.16 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 336 | 4.17 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 280 | 1.73 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 224 | 2.01 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 392 | 3.69 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 168 | 3.61 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 168 | 1.86 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 112 | 2.04 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 504 | 3.91 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 112 | 3.89 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 56 | 1.99 1000 cells /cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 0/Enrollment | 1.87 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 112 | 3.03 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 168 | 3.17 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 224 | 2.89 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 280 | 3.12 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 504 | 1.79 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 336 | 3.04 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 392 | 2.86 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 448 | 3.05 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 504 | 2.81 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 728 | 2.3 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- Screening | 1.6 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 0/Enrollment | 1.64 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 56 | 1.86 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 728 | 1.5 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 112 | 1.77 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 168 | 1.61 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 224 | 1.61 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 280 | 1.7 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 336 | 1.76 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 392 | 1.58 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 448 | 1.8 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- Screening | 3.24 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 0/Enrollment | 2.98 1000 cells /cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 56 | 2.78 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 448 | 1.89 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- Screening | 3.76 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 728 | 2.65 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 112 | 3.02 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 280 | 2.1 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 504 | 3.39 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 224 | 3.02 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 448 | 2.97 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 336 | 3.08 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 392 | 1.91 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 56 | 3.47 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 336 | 2.12 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 56 | 2.12 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 280 | 3.15 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 168 | 1.97 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 112 | 1.91 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- Screening | 1.92 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 0/Enrollment | 1.86 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 392 | 3.53 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 504 | 1.94 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 728 | 2.93 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 224 | 1.94 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 0/Enrollment | 3.31 1000 cells /cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 168 | 3.19 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- Screening | 2.82 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 448 | 3.04 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 0/Enrollment | 3.16 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 504 | 1.76 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 448 | 1.99 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 112 | 1.93 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 392 | 2.84 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 168 | 1.89 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 728 | 1.69 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 224 | 1.74 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 336 | 2.83 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 280 | 1.92 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 0/Enrollment | 1.95 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 336 | 1.82 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 280 | 2.94 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 56 | 3.28 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 392 | 1.82 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 224 | 2.75 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 168 | 2.84 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 728 | 3.63 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 56 | 1.87 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 112 | 3.17 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- Screening | 1.86 1000 cells /cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 504 | 3.02 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 56 | 7.27 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 280 | 2.86 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 168 | 6.19 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 448 | 2.87 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 336 | 6.51 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 448 | 6.24 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- Screening | 3.37 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 728 | 3.89 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- Screening | 3.06 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 224 | 3.13 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 0/Enrollment | 5.82 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 728 | 4.8 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 112 | 5.9 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 392 | 6.13 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 0/Enrollment | 2.94 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 504 | 6.42 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 336 | 2.95 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 504 | 2.96 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 280 | 5.27 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 168 | 3.27 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 392 | 2.82 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 56 | 2.97 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Neutrophils (1000/cubic mm)- 224 | 4.96 1000 cells /cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count | Lymphocytes (1000/cubic mm)- 112 | 3.46 1000 cells /cubic mm |
Primary
Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC)
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time frame: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728
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 (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 168 | 255.5 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 260 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 392 | 255.85 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 112 | 244.45 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 0/Enrollment | 254.9 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 56 | 262.65 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 336 | 242 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 112 | 6.23 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 728 | 7.12 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 168 | 5.81 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 0/Enrollment | 6.2 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 224 | 6.5 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 504 | 271.35 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 280 | 6.26 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 728 | 283.2 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 336 | 5.39 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 448 | 249 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 392 | 5.43 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 56 | 5.41 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 280 | 252.9 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 448 | 5.66 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 224 | 264 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 6.4 1000 cells/cubic mm |
| Group 1: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 504 | 5.67 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 224 | 5.93 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 112 | 250 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 280 | 249 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 251 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 448 | 243.5 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 504 | 6.3 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 392 | 5.9 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 448 | 6.26 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 56 | 255 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 56 | 6.76 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 0/Enrollment | 239 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 504 | 252.65 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 336 | 246 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 6.15 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 336 | 6 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 728 | 278 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 112 | 6.39 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 0/Enrollment | 6.9 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 280 | 6.59 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 392 | 255.5 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 728 | 6.6 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 224 | 252 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 168 | 255.5 1000 cells/cubic mm |
| Group 2: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 168 | 5.51 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 112 | 6.67 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 504 | 257.5 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 448 | 6 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 224 | 6.35 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 728 | 250 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 728 | 7.02 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 280 | 7 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 6.8 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 448 | 264 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 392 | 265 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 168 | 278.5 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 336 | 7.04 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 112 | 284.5 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 336 | 270.5 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 280 | 278 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 271 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 56 | 275.5 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 392 | 6.6 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 0/Enrollment | 254 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 504 | 6.32 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 56 | 6.45 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 224 | 283 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 168 | 6.03 1000 cells/cubic mm |
| Group 3: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 0/Enrollment | 6.51 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 168 | 271 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 0/Enrollment | 5.65 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 56 | 5.44 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 112 | 5.4 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 168 | 5.28 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 224 | 5.3 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 280 | 5.56 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 336 | 5.43 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 392 | 5.08 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 448 | 5.45 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 504 | 5.55 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 728 | 4.8 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 273 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 0/Enrollment | 270 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 56 | 283 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 112 | 267 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 224 | 252 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 280 | 250 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 336 | 256 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 392 | 251 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 448 | 260 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 728 | 233 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 504 | 268.5 1000 cells/cubic mm |
| Group 4: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 6.06 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 280 | 254.45 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 56 | 246 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 336 | 5.76 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 224 | 6 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 336 | 238.5 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 728 | 263.5 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 280 | 6.4 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 392 | 252 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 112 | 252.8 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 168 | 240.5 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 244.5 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 448 | 254.4 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 0/Enrollment | 247 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 448 | 6.7 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 112 | 5.85 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 728 | 6.6 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 168 | 5.87 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 224 | 234 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 6.7 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 0/Enrollment | 6.1 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 392 | 6.13 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 504 | 248.5 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 504 | 6.16 1000 cells/cubic mm |
| Group 5: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 56 | 6.1 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 224 | 256.5 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 728 | 6.18 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 336 | 233 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 112 | 261.5 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 448 | 5.7 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 168 | 257 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 392 | 5.6 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 336 | 5.49 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 280 | 257 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 392 | 250 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 280 | 5.8 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 0/Enrollment | 5.9 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 224 | 5.4 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 448 | 255 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 728 | 302 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 504 | 251 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 5.9 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 168 | 5.7 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 504 | 5.05 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 112 | 6 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 0/Enrollment | 244.5 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 240.1 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 56 | 5.9 1000 cells/cubic mm |
| Group 6: Vaccine | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 56 | 246 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 0/Enrollment | 283 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 224 | 341 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 728 | 9.3 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 168 | 303 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- Screening | 7.1 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- Screening | 315 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 336 | 310 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 112 | 316 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 504 | 8.7 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 112 | 9.7 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 56 | 326 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 392 | 9.5 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 504 | 323 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 0/Enrollment | 9.8 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 224 | 8.8 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 280 | 284.5 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 56 | 10.1 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 280 | 8.7 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 448 | 8.6 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 728 | 327 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 392 | 319 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 168 | 8.9 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | Platelets (1000/cubic mm)- 448 | 336 1000 cells/cubic mm |
| Group 7: Placebo | Chemistry and Hematology Laboratory Measures - Platelets, White Blood Cells (WBC) | WBC (1000/cubic mm)- 336 | 8.8 1000 cells/cubic mm |
Primary
Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC).
The number (percentage) of participants with lab grade \>= 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm
Time frame: Measured during screening, Days 0, 56, 112, 168, 224, 280, 336, 392, 448, 504, 728
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) |
|---|---|---|---|
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 448 | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 56 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 336 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 56 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 504 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 168 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 392 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 336 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 336 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 728 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 224 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 336 | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 112 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 224 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 56 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 392 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 168 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 280 | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 0/Enrollment | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 224 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 280 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 0/Enrollment | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 504 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 168 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 224 | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 504 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 168 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 56 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 280 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 280 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 168 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 112 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 224 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 112 | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 448 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 112 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 728 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 448 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 392 | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 728 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 336 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 728 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 728 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 336 | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 504 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 280 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 168 | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 392 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 112 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 224 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 448 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 56 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 392 | 3 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 112 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 448 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 112 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 392 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 392 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 504 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 504 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 280 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 728 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 448 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 336 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 224 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 56 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 728 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 280 | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 0/Enrollment | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 168 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 504 | 1 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- Screening | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 448 | 0 Participants |
| Group 1: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 56 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 448 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 728 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 336 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 56 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 112 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 336 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 280 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 168 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 280 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 224 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 224 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 280 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 168 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 336 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 392 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 168 | 1 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 392 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 112 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 448 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 392 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 504 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 56 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 728 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 448 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 336 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 56 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 504 | 1 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 504 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 336 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 728 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 224 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 280 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 0/Enrollment | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 0/Enrollment | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 112 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 56 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 728 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 224 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 112 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 168 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 280 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 112 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 168 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 224 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 280 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 112 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 336 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 392 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 336 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 56 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 448 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 392 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 504 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 504 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 0/Enrollment | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 728 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 392 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 448 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 56 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 504 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 0/Enrollment | 1 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 728 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 728 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 448 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- Screening | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 224 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 504 | 1 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 0/Enrollment | 1 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 56 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 168 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 448 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 112 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 168 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 280 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 392 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 224 | 0 Participants |
| Group 2: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- Screening | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- Screening | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 224 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 224 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 0/Enrollment | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 0/Enrollment | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 224 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 504 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 448 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 448 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 336 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 728 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 504 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 168 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 728 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 56 | 2 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 56 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 504 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- Screening | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 392 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- Screening | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- Screening | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 280 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 448 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 168 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 448 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 392 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 168 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 392 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 728 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 392 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 112 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 504 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 56 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 112 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 336 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 168 | 1 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 448 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 728 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 448 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 392 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 168 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 112 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 56 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 168 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 224 | 1 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 504 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 168 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 280 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 280 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- Screening | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 0/Enrollment | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 112 | 1 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 392 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 224 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 280 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 112 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 224 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 112 | 1 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 728 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 280 | 1 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 280 | 1 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 56 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 728 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 728 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 280 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 336 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 504 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 56 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 336 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 56 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 504 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 112 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 392 | 1 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 336 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 336 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 336 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 224 | 0 Participants |
| Group 3: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 448 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 504 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 336 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 56 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 112 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 168 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 728 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 224 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 280 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 504 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 336 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 392 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 448 | 1 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 224 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 448 | 1 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 280 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 112 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 336 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 392 | 2 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 392 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 448 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 336 | 2 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 504 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 728 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 56 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 280 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 0/Enrollment | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 224 | 1 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 56 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 112 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 168 | 2 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 168 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 224 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 112 | 1 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 280 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 112 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 336 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 56 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 392 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 224 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 448 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 0/Enrollment | 1 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 504 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 728 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- Screening | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 392 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 448 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- Screening | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 728 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 504 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 728 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 728 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- Screening | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- Screening | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 448 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 56 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 112 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 392 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 168 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 168 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- Screening | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 336 | 1 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 56 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 280 | 2 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 112 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 168 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 224 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 224 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 280 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 280 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 168 | 1 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 336 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 392 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 504 | 1 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 448 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 56 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 504 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 728 | 0 Participants |
| Group 4: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 0/Enrollment | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 112 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 56 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 112 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 168 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 224 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 280 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 336 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 280 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 336 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 392 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 448 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 504 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 728 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 0/Enrollment | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 56 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 112 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 168 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 224 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 280 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 336 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 392 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 448 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 504 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 728 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 392 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 448 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 504 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 728 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- Screening | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 56 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 112 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 168 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- Screening | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 56 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 112 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 168 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 224 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 280 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 336 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 392 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 448 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 504 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 728 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- Screening | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 56 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 168 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 224 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 280 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 336 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 392 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 448 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 504 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 728 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 0/Enrollment | 1 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 56 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 168 | 1 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 224 | 1 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 280 | 1 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 336 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 392 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 448 | 1 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 504 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 728 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- Screening | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 0/Enrollment | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 56 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- Screening | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 168 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 224 | 1 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 280 | 1 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 336 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 392 | 3 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 448 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 504 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 728 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 224 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 112 | 0 Participants |
| Group 5: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 112 | 2 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 168 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 0/Enrollment | 1 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 504 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 448 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 504 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 56 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 392 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 336 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 280 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 168 | 1 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 224 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 168 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 224 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 112 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 56 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 224 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 280 | 1 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- Screening | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 336 | 1 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 728 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 112 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 168 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 392 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 56 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- Screening | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 448 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- Screening | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 728 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 728 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 504 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 504 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 448 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 728 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 392 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 728 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- Screening | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 504 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 448 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 112 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 0/Enrollment | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 392 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 336 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 56 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 280 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 224 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 112 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 168 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 112 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 56 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 168 | 1 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 56 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 0/Enrollment | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 224 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 728 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 280 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 504 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 448 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 112 | 1 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 336 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 392 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 336 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 112 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 392 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 280 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 224 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 448 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 392 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 448 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 336 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 280 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 336 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 504 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 224 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 168 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 728 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 56 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 280 | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 6: Vaccine | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- Screening | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 728 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- Screening | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 336 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 0/Enrollment | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 504 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 336 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 448 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 112 | 1 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 56 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 56 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 56 | 1 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 392 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 280 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 336 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 728 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 280 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 224 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 504 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 504 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 168 | 1 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 224 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 56 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 168 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 392 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 224 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 112 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 224 | 1 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 112 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 168 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 56 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 280 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 112 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 224 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 280 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 224 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Lymphocytes (1000/cubic mm)- Screening | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 168 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 168 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 336 | 1 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 168 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 56 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 112 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 112 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 0/Enrollment | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 168 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 392 | 1 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 56 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 0/Enrollment | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 448 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 224 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- Screening | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 448 | 1 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- Screening | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 392 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 728 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 728 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- Screening | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 336 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 504 | 1 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 504 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 280 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 448 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 280 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 728 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 504 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | ALT (SGPT) (U/L)- 728 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 392 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 448 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 728 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 448 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | WBC (1000/cubic mm)- 112 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 336 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- Screening | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 504 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- Screening | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 448 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Platelets (1000/cubic mm)- 280 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 336 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Neutrophils (1000/cubic mm)- 392 | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Creatinine (mg/dL)- 0/Enrollment | 0 Participants |
| Group 7: Placebo | Number of Lab Grade >= 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC). | Hemoglobin (g/dL)- 392 | 0 Participants |
Primary
Number of Participants Reporting Local Reactogenicity 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 through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Not gradable | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 - less than 25cm^2 area | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 - less than 100cm^2 area | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Not gradable | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 14 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 - less than 25cm^2 area | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 - less than 100cm^2 area | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm dim. | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Not gradable | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 16 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Not gradable | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 - less than 5cm dim. | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: complications AE | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 3 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 16 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: complications AE | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 - less than 5cm dim. | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 - less than 10cm dim. | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Not gradable | 3 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 16 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 20 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm dim. | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Not gradable | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: complications AE | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm dim. | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 - less than 10cm dim. | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm dim. | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm dim. | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 - less than 25cm^2 area | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm dim. | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 - less than 10cm dim. | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 - less than 5cm dim. | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 - less than 5cm dim. | 3 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 - less than 10cm dim. | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: complications AE | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 - less than 100cm^2 area | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 100cm^2 area | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 - less than 100cm^2 area | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 - less than 25cm^2 area | 4 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm dim. | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 100cm^2 area | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 - less than 25cm^2 area | 4 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Not gradable | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 12 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 7 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 - less than 100cm^2 area | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: complications AE | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 - less than 5cm dim. | 4 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 6 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 100cm^2 area | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Not gradable | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: complications AE | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 - less than 10cm dim. | 5 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm dim. | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 6 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: complications AE | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 12 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Not gradable | 6 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: complications AE | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 - less than 10cm dim. | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 - less than 100cm^2 area | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm dim. | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Not gradable | 3 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: complications AE | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 4 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 - less than 5cm dim. | 2 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 - less than 25cm^2 area | 3 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 - less than 10cm dim. | 4 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 - less than 100cm^2 area | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm dim. | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 7 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 - less than 5cm dim. | 2 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 - less than 25cm^2 area | 3 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm dim. | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 - less than 25cm^2 area | 2 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: complications AE | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 - less than 25cm^2 area | 2 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 - less than 25cm^2 area | 1 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm dim. | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Not gradable | 2 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 18 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 19 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm dim. | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Not gradable | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: complications AE | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 17 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: complications AE | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 2 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: complications AE | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Not gradable | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 4: complications AE | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: >= 10cm dim. | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 10cm dim. | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Missing | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Missing | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: complications AE | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 4: complications AE | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 4: complications AE | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 5 - less than 10cm dim. | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 3: complications AE | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Gr 1: 2.5 - less than 5cm dim. | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 3: >= 100cm^2 area | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Not gradable | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Gr 1: 6.25 - less than 25cm^2 area | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema/Redness | Not gradable | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 2: 25 - less than 100cm^2 area | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Erythema and/or Induration | Gr 3: >= 10cm dim. | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | Missing | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration | Induration/Swelling | None | 3 Participants |
Primary
Number of Participants Reporting Local Reactogenicity 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 through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 12 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 6 Participants |
| Group 1: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 8 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 11 Participants |
| Group 2: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 5 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 15 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 8 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 11 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 5 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 15 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 7 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 13 Participants |
| Group 6: Vaccine | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 1 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | None | 2 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Mild | 1 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness | Moderate | 0 Participants |
Primary
Number of Participants Reporting Systemic Reactogenicity 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 following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Time frame: Measured through 3 days after each vaccine dose at Weeks 0, 16, 32, 48, 64
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 7 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 3 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 18 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 8 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 1 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 13 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 15 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 17 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 10 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 2 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 19 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Severe | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 6 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Moderate | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 4 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 1: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | None | 18 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | None | 19 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 15 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 16 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 10 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 3 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 9 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 4 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | None | 18 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 5 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | None | 19 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | None | 19 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 11 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 16 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | None | 19 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 6 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 2 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Mild | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Severe | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 17 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 18 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Moderate | 0 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Group 2: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Mild | 2 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 2 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | None | 19 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 14 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | None | 21 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 4 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 8 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 7 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 5 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 2 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 18 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 4 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 12 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 5 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 4 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 13 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 5 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 3 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | None | 21 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 17 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 3 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 3 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 1 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | None | 17 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Mild | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Mild | 4 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | None | 21 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | None | 19 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Mild | 2 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Severe | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Moderate | 0 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 14 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 4 Participants |
| Group 3: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | None | 19 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 18 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 20 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Mild | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 10 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 3 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | None | 21 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 6 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 12 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | None | 21 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 21 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 3 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 19 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | None | 21 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 6 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 5 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 12 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Mild | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | None | 20 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 6 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 2 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 5 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Mild | 1 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 16 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Moderate | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | None | 21 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 4: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | None | 20 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 17 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 3 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 13 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 6 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 16 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 4 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 18 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 2 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 18 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | None | 19 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | None | 19 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 19 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | None | 19 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | None | 19 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Mild | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | None | 20 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Moderate | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 11 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 8 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 1 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 20 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 5: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Moderate | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 20 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 1 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Moderate | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 1 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Moderate | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 7 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 13 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Moderate | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 20 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Mild | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 3 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 8 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 4 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Moderate | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 3 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 10 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 18 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 14 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | None | 21 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 4 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 3 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 17 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 19 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Moderate | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Mild | 2 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Mild | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | None | 21 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | None | 21 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | None | 21 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Potentially Life-threatening | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | None | 19 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | None | 21 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Mild | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 2 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Mild | 0 Participants |
| Group 6: Vaccine | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Mild | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Mild | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | Mild | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Facial flushing | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Mild | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Mild | 1 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | None | 2 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Generalized Pruritus | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | Mild | 1 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Mild | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Chills | None | 2 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Nausea | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Mild | 1 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | None | 2 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | Mild | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Headache | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Urticaria | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | None | 1 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Mild | 2 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | None | 1 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Temperature | Mild | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Mild | 2 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | Mild | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Myalgia | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Mild | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Malaise and/or fatigue | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional tachycardia | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Potentially Life-threatening | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Non-exertional dyspnea | Severe | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Unexplained diaphoresis | None | 3 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Moderate | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Arthralgia | Mild | 0 Participants |
| Group 7: Placebo | Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms | Max. Systemic Symptoms | Severe | 0 Participants |
Primary
VRC07523LS Serum Concentrations
VRC07523LS serum concentrations measured in healthy human subjects after up to five administrations of the study product via the IV, SC or IM routes at various doses. Serum concentrations between the first and second study product administrations (Target Visit Day 0-112) were measured using ELISA assay in all enrolled participants. Serum concentrations after the second study product administrations (Target Visit Day 168-784) were measured using BAMA (LUMINEX) assay in a subset of participants enrolled in each treatment group and all particiants in plocebo group. serum concentrations below the lower limit of quantification (LLoQ) were replaced by half the LLoQ. Thus, concentrations below the LLoQ when measured by the ELISA assay were replaced by 0.5 ug/ml and concentrations below the LLoQ when measured by the BAMA assay were replaced by 0.02285 ug/ml.
Time frame: Target Visit Days 0, 3, 6, 28, 56, 84, 112, 168, 224, 280, 336, 392, 448, 504, 560, 616, 672, 728, 784 (i.e., visit numbers 2 through 20)
Population: Overall Number of Participants Analyzed represents the number of enrolled participants. Number Analyzed shows the number of participants with available data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-504) | 14.18 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-392) | 13.31 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-168) | 13.14 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-000) | 0.5 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-056) | 10.67 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-028) | 14.56 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-784) | 0.51 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-112) | 4.08 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-280) | 12.17 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-006) | 27.71 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-003) | 43.13 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-336) | 5.5 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-728) | 0.47 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-616) | 2.7 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-560) | 5.08 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-084) | 5.43 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-672) | 1.14 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-448) | 5.6 ug/ml |
| Group 1: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-224) | 5.55 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-560) | 10.67 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-112) | 6.51 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-392) | 25.88 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-084) | 12.19 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-280) | 25.77 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-504) | 23.4 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-336) | 11.15 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-224) | 9.83 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-448) | 10.29 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-056) | 17.08 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-000) | 0.5 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-006) | 59.05 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-028) | 27.86 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-003) | 80.7 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-728) | 1.68 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-168) | 22.46 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-616) | 5.74 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-784) | 0.94 ug/ml |
| Group 2: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-672) | 2.81 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-006) | 224 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-392) | 98.93 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-504) | 98.2 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-168) | 98.34 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-672) | 10.68 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-028) | 125.17 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-224) | 36.11 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-000) | 0.5 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-616) | 20.78 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-003) | 332.57 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-056) | 68.97 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-084) | 45.27 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-280) | 93.35 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-112) | 26.83 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-784) | 2.17 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-336) | 38.01 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-728) | 5.87 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-448) | 40.22 ug/ml |
| Group 3: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-560) | 41.17 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-392) | 6.12 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-280) | 7.52 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-784) | 0.17 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-056) | 5.02 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-003) | 11.06 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-084) | 2.99 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-224) | 2.31 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-616) | 1.52 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-000) | 0.5 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-168) | 5.77 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-006) | 11.04 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-504) | 6.11 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-672) | 0.78 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-560) | 1.65 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-448) | 2.71 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-028) | 6.79 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-336) | 2.16 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-112) | 0.5 ug/ml |
| Group 4: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-728) | 0.45 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-224) | 5.95 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-084) | 5.9 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-112) | 3.95 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-168) | 10.99 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-000) | 0.5 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-056) | 7.63 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-280) | 13.65 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-336) | 6.39 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-003) | 17.81 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-006) | 22.22 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-028) | 13.37 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-392) | 12.76 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-448) | 6.06 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-504) | 13.22 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-560) | 7.17 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-672) | 1.29 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-728) | 0.74 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-784) | 0.36 ug/ml |
| Group 5: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-616) | 3.63 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-560) | 3.92 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-336) | 3.62 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-056) | 6.27 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-112) | 2.98 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-224) | 3.53 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-728) | 0.44 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-784) | 0.27 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-616) | 1.36 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-000) | 0.5 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-672) | 1.25 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-168) | 8.09 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-028) | 10.03 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-448) | 3.59 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-392) | 8.13 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-504) | 7.61 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-280) | 7.79 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-003) | 16.71 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-084) | 4.29 ug/ml |
| Group 6: Vaccine | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-006) | 16.03 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-392) | 0.02 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-006) | 0.5 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-112) | 0.5 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-003) | 0.5 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-336) | 0.02 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-084) | 0.5 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-728) | 0.02 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-280) | 0.02 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-056) | 0.5 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-784) | 0.02 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-560) | 0.02 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-224) | 0.02 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-000) | 0.5 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-168) | 0.02 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-448) | 0.02 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-504) | 0.02 ug/ml |
| Group 7: Placebo | VRC07523LS Serum Concentrations | IDVRC07-523LS (Day-028) | 0.5 ug/ml |
Secondary
Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration.
Magnitude-breadth characterize the magnitude (ID50 or ID80 titers) and breadth (number of virus isolates) of each individual serum sample assayed against a panel of virus isolates. MB curves show, for each possible magnitude threshold, the fraction of assays with magnitudes greater than this threshold. The area under the magnitude-breadth curve (AUC-MB) is calculated as the average of the log10-based ID50 or ID80 titers over the panel of isolates. Isolates includes: H703\_0646\_051sN, H703\_1471\_190s, H703\_1750\_140Es, H704\_0726\_080sN, H704\_1535\_030sN, H704\_2544\_140eN01, PVO.4.
Time frame: Weeks 8, 72, and 88 following the first study product administration
Population: Overall Number of Participants Analyzed- represents the number of sampled participants. Number Analyzed shows the number of participants with available nAb data after filtering for assay specific quality control criteria at each timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-72) | 1.27 log10(titer) |
| Group 1: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-08) | 1.14 log10(titer) |
| Group 1: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-08) | 1.56 log10(titer) |
| Group 1: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-88) | 0.98 log10(titer) |
| Group 1: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-72) | 1.62 log10(titer) |
| Group 1: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-88) | 0.85 log10(titer) |
| Group 2: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-88) | 1.4 log10(titer) |
| Group 2: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-08) | 1.89 log10(titer) |
| Group 2: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-08) | 1.37 log10(titer) |
| Group 2: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-72) | 1.49 log10(titer) |
| Group 2: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-88) | 0.91 log10(titer) |
| Group 2: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-72) | 2.03 log10(titer) |
| Group 3: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-88) | 1.93 log10(titer) |
| Group 3: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-08) | 1.97 log10(titer) |
| Group 3: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-72) | 2.14 log10(titer) |
| Group 3: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-72) | 2.6 log10(titer) |
| Group 3: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-88) | 1.45 log10(titer) |
| Group 3: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-08) | 2.46 log10(titer) |
| Group 4: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-72) | 1 log10(titer) |
| Group 4: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-72) | 1.36 log10(titer) |
| Group 4: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-88) | 0.7 log10(titer) |
| Group 4: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-88) | 0.8 log10(titer) |
| Group 4: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-08) | 0.93 log10(titer) |
| Group 4: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-08) | 1.34 log10(titer) |
| Group 5: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-08) | 1.54 log10(titer) |
| Group 5: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-72) | 1.21 log10(titer) |
| Group 5: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-88) | 0.97 log10(titer) |
| Group 5: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-88) | 0.84 log10(titer) |
| Group 5: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-72) | 1.6 log10(titer) |
| Group 5: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-08) | 1.15 log10(titer) |
| Group 6: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-08) | 1.01 log10(titer) |
| Group 6: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-88) | 0.9 log10(titer) |
| Group 6: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-72) | 1.13 log10(titer) |
| Group 6: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-72) | 1.49 log10(titer) |
| Group 6: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID80 (Week-88) | 0.75 log10(titer) |
| Group 6: Vaccine | Magnitude and Breadth of Neutralizing Antibody Responses Against Autologous Viral Isolates as Assessed by Area Under the Magnitude-breadth Curves 8, 72, 88 Weeks After the First Study Product Administration. | ID50 (Week-08) | 1.39 log10(titer) |
Secondary
Occurrence of Antidrug Antibodies (ADA)
Antidrug antibodies (ADA) are most typically detected and characterized using a tiered testing strategy. In Tier I, a sensitive binding assay is used to determine if samples may have ADA present. In Tier II, the response is confirmed, typically by establishing the specificity of the response by competition with free drug. In Tier III, the response is characterized, typically with a neutralization reduction assay and/or a titering assay.
Time frame: Day 0, 6, 112, 224, 448
Population: Overall Number of Participants Analyzed presents the number of enrolled participants in each treatment arm. Number Analyzed shows the number of samples available and tested in the certain tier and timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 224 - Tier I | 0 Participants |
| Group 1: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier II | 0 Participants |
| Group 1: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier I | 2 Participants |
| Group 1: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 448 - Tier I | 0 Participants |
| Group 2: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 448 - Tier I | 1 Participants |
| Group 2: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier I | 2 Participants |
| Group 2: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier II | 0 Participants |
| Group 2: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 224 - Tier I | 0 Participants |
| Group 2: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 448 - Tier II | 0 Participants |
| Group 2: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 6 - Tier I | 0 Participants |
| Group 3: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 224 - Tier I | 0 Participants |
| Group 3: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 112 - Tier I | 0 Participants |
| Group 3: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier I | 0 Participants |
| Group 3: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 448 - Tier I | 0 Participants |
| Group 4: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier II | 0 Participants |
| Group 4: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 224 - Tier I | 1 Participants |
| Group 4: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 224 - Tier II | 1 Participants |
| Group 4: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier I | 2 Participants |
| Group 4: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 448 - Tier I | 0 Participants |
| Group 4: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 224 - Tier III | 0 Participants |
| Group 5: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 224 - Tier I | 0 Participants |
| Group 5: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 448 - Tier I | 0 Participants |
| Group 5: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier I | 0 Participants |
| Group 5: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 112 - Tier I | 0 Participants |
| Group 6: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier I | 1 Participants |
| Group 6: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 448 - Tier I | 0 Participants |
| Group 6: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier II | 0 Participants |
| Group 6: Vaccine | Occurrence of Antidrug Antibodies (ADA) | 224 - Tier I | 0 Participants |
| Group 7: Placebo | Occurrence of Antidrug Antibodies (ADA) | 224 - Tier I | 0 Participants |
| Group 7: Placebo | Occurrence of Antidrug Antibodies (ADA) | 0 - Tier I | 0 Participants |
| Group 7: Placebo | Occurrence of Antidrug Antibodies (ADA) | 448 - Tier I | 0 Participants |