Hepatitis B
Conditions
Keywords
Hepatitis B, Hepatitis B virus, Hepatitis B surface antigen, Aluminum hydroxide, Adjuvant System, Safety, Immunogenicity
Brief summary
This study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from other approved adjuvant systems and from an aluminum-based adjuvant.
Interventions
COMBINATION_PRODUCTGSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide
Three doses of GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide administered intramuscularly in the non-dominant arm, one each at Day 1, Day 31 and Day 181.
BIOLOGICALGSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system
Two doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.
BIOLOGICALGSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system
Two doses of GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.
BIOLOGICALGSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg)
Two doses of GSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37B adjuvant system (50 μg) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.
BIOLOGICALGSK's HBsAg (20 μg) vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg)
Two doses of GSK's HBsAg (20 μg )vaccine adjuvanted with GSK's AS37A adjuvant system (100 μg) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 31.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants who the investigator believe can and will comply with the requirements of the protocol. * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Healthy participants as established by medical history, clinical examination and clinical laboratory assessment before entering the study. * A male or female between, and including, 18 and 45 years at the time of the first study intervention administration. * Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. * Female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 1 month prior to study intervention administration, and * has a negative pregnancy test on the day of study intervention administration, and * has agreed to continue adequate contraception during the entire treatment period and for at least 3 months after completion of the study intervention administration series. * blood sample for simultaneous follicle-stimulating hormone (FSH) and estradiol levels may be collected at the discretion of the investigator to confirm non-reproductive potential according to local laboratory reference range.
Exclusion criteria
Medical conditions * Previous vaccination against Hepatitis B. * Positive for anti-HBs antibodies or anti-HBc antibodies or HBsAg. * Any previous administration of monophosphoryl lipid (MPL) and/or AS37. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Any confirmed or suspected autoimmune disease. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s). * Recurrent history or uncontrolled neurological disorders or seizures. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. * Any clinically significant\* haematological and/or biochemical laboratory abnormality. \*The investigator should use his/her clinical judgement to decide which abnormalities are clinically significant. * Any past or current malignancies and lymphoproliferative disorders. Prior/Concomitant therapy * Use of any investigational or non-registered product (drug or vaccine) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) or their planned use during the study period. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study intervention(s) administration with the exception of influenza vaccine (pandemic or seasonal). * A vaccine not foreseen by the study protocol administered during the period starting at Visit 1 or 30 days before each dose and ending 30 days after the last dose of study intervention(s) administration\*, with the exception of influenza vaccine (pandemic or seasonal). \*In case emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by public health authorities outside the routine immunisation programme, the time period described above can be reduced if necessary for that vaccine, provided it is licensed/authorised and used according to its Product Information. * Administration of long-acting immune-modifying drugs at any time during the study period. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months before the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent ≥ 20 mg/day. Inhaled and topical steroids are allowed. * Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study intervention(s) or planned administration during the study period. Prior/Concurrent clinical study experience * Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational intervention. Other exclusions * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * History of chronic alcohol consumption and/or drug abuse. * Any study personnel or their immediate depandants, family, or household members. Specific exclusion for MRI-assessable subgroup participants (post-randomization procedure) * Presence of pacemakers, metal implants and/or prostheses. * Claustrophobia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | At Day 61 | In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | At Day 8 | In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | At Day 31 | In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | At Day 38 | In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
| Number of Participants With Any Unsolicited AEs After Dose 2 | Day 31 (day of administration) to Day 61 | Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. |
| Number of Participants With Any Unsolicited AEs After Dose 1 | Day 1 (day of administration) to Day 31 | An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. |
| Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Day 1 (day of administration) to Day 14 | Assessed solicited administration site events after vaccination included erythema, pain, and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. |
| Number of Participants With Solicited Administration Site AEs After Dose 2 | Day 31 (day of administration) to Day 45 | Assessed solicited administration site events after vaccination included erythema, pain and swelling at the injection site. Any = occurrence of the event regardless of intensity grade. |
| Number of Participants With Solicited Systemic AEs After Dose 1 | Day 1 (day of administration) to Day 14 | Assessed solicited systemic events included fever (defined as temperature greater than or equal to (\>=) 38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea. |
| Number of Participants With Solicited Systemic AEs After Dose 2 | Day 31 (day of administration) to Day 45 | Assessed solicited systemic events included fever (defined as temperature \>=38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea. |
| Duration in Days of Solicited Administration Site AEs After Dose 1 | Day 1 (day of administration) to Day 14 | Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period. |
| Duration in Days of Solicited Administration Site AEs After Dose 2 | Day 31 (day of administration) to Day 45 | Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period. |
| Duration in Days of Solicited Systemic AEs After Dose 1 | Day 1 (day of administration) to Day 14 | Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period. |
| Duration in Days of Solicited Systemic AEs After Dose 2 | Day 31 (day of administration) to Day 45 | Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period. |
| Number of Participants With Serious AEs (SAEs) | Throughout the entire study period (from Day 1 to Day 361) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or is an abnormal pregnancy outcome. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. |
| Number of Participants With Medically Attended AEs (MAEs) | Throughout the entire study period (from Day 1 to Day 361) | An MAE is any AE with medically attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of the MAE regardless of intensity grade or relation to the study vaccination. |
| Number of Participants With AEs Leading to Study Withdrawal | Throughout the entire study period (from Day 1 to Day 361) | An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact. |
| Number of Participants With Potential Mediated Immune Diseases (pIMDs) | Throughout the entire study period (from Day 1 to Day 361) | pIMDs are a subset of adverse events that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination. |
| Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | At Day 8 (relative to baseline [pre-vaccination Day 1]) | In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC). |
| Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | At Day 38 (compared with baseline [pre-vaccination, Day 1]) | In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC. |
| Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | At Day 1 (baseline) | In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Seroconverted for Anti-HBs | At Day 31, Day 61 and Day 361 | A participant who seroconverted for anti-HBs is defined as a participant with an anti-HBs antibody concentration higher than (\>) 6.2 mIU/mL. |
| Percentage of Participants Seroprotected for Anti-HBs | At Day 31, Day 61 and Day 361 | A participant seroprotected for anti-HBs is defined as a participant with an anti-HBs antibody concentration \>10 mIU/mL. |
| Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | At Day 1, Day 31, Day 61 and Day 361 | Anti-HBs antibody concentration was measured as GMC and expressed in milli international units per milliliter (mIU/mL). |
Countries
Belgium, Germany, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HBs-alum Group Participants received 3 doses of GSK's Hepatitis B (HBsAg) vaccine adjuvanted with aluminum hydroxide, at Day 1, Day 31 and Day 181. | 25 |
| HBs-AS03 Group Participants received 2 doses of GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03, adjuvant system, at Day 1 and Day 31. | 25 |
| HBs-AS04 Group Participants received 2 doses of GSK's HBsAg vaccine adjuvanted with GSK's AS04, adjuvant system, at Day 1 and Day 31. | 24 |
| HBs-AS37B Group Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37B adjuvant system (50 µg), at Day 1 and Day 31. | 25 |
| HBs-AS37A Group Participants received 2 doses of GSK's HBsAg (20 µg) candidate vaccine adjuvanted with GSK's AS37A adjuvant system (100 µg), at Day 1 and Day 31. | 23 |
| Total | 122 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Consent withdrawal, not due to (S)AE | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Other | 1 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | HBs-alum Group | HBs-AS03 Group | HBs-AS04 Group | HBs-AS37B Group | HBs-AS37A Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 35.9 YEARS STANDARD_DEVIATION 5.8 | 37.5 YEARS STANDARD_DEVIATION 6.4 | 34.5 YEARS STANDARD_DEVIATION 7.9 | 38.6 YEARS STANDARD_DEVIATION 6 | 37.3 YEARS STANDARD_DEVIATION 7.7 | 36.8 YEARS STANDARD_DEVIATION 6.8 |
| Race/Ethnicity, Customized Other Races | 2 Participants | 0 Participants | 2 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 23 Participants | 25 Participants | 22 Participants | 23 Participants | 22 Participants | 115 Participants |
| Sex: Female, Male Female | 11 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 51 Participants |
| Sex: Female, Male Male | 14 Participants | 15 Participants | 14 Participants | 15 Participants | 13 Participants | 71 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 24 | 0 / 25 | 0 / 23 |
| other Total, other adverse events | 24 / 25 | 21 / 25 | 23 / 24 | 23 / 25 | 23 / 23 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 24 | 1 / 25 | 0 / 23 |
Outcome results
Primary
Duration in Days of Solicited Administration Site AEs After Dose 1
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Time frame: Day 1 (day of administration) to Day 14
Population: The analysis was performed on the ES. Only participants who experienced solicited administration site events after dose 1 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited administration site events at dose 1.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HBs-alum Group | Duration in Days of Solicited Administration Site AEs After Dose 1 | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Administration Site AEs After Dose 1 | 1.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Administration Site AEs After Dose 1 | 3.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Administration Site AEs After Dose 1 | 2.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Administration Site AEs After Dose 1 | 1.0 Days |
Primary
Duration in Days of Solicited Administration Site AEs After Dose 2
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Time frame: Day 31 (day of administration) to Day 45
Population: The analysis was performed on the ES. Only participants who experienced solicited administration site events after dose 2 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited administration site events at dose 2.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| HBs-alum Group | Duration in Days of Solicited Administration Site AEs After Dose 2 | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Administration Site AEs After Dose 2 | 2.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Administration Site AEs After Dose 2 | 4.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Administration Site AEs After Dose 2 | 1.5 Days |
| HBs-AS37A Group | Duration in Days of Solicited Administration Site AEs After Dose 2 | 2.0 Days |
Primary
Duration in Days of Solicited Systemic AEs After Dose 1
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Time frame: Day 1 (day of administration) to Day 14
Population: The analysis was performed on the ES. Only participants who experienced solicited systemic events after dose 1 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited systemic events at dose 1.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Arthralgia | 2.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Chills | 1.5 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Diarrhea | 1.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Fatigue | 1.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Headache | 1.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Loss of appetite | 5.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Malaise | 1.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Myalgia | 1.5 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Nausea | 1.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Fever | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Diarrhea | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Fatigue | 2.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Headache | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Loss of appetite | 1.5 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Malaise | 1.5 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Fever | 2.5 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Myalgia | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Arthralgia | 1.5 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Arthralgia | 1.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Loss of appetite | 1.5 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Nausea | 1.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Fatigue | 1.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Malaise | 1.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Headache | 1.5 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Fever | 3.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Myalgia | 2.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Diarrhea | 1.5 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Chills | 1.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Myalgia | 1.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Malaise | 1.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Arthralgia | 2.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Headache | 1.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Fatigue | 1.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Loss of appetite | 4.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Nausea | 1.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Fever | 3.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Chills | 3.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Headache | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Nausea | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Myalgia | 2.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Malaise | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Arthralgia | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Diarrhea | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 1 | Fatigue | 2.0 Days |
Primary
Duration in Days of Solicited Systemic AEs After Dose 2
Duration is the number of days in which a participant experienced the symptom within the 14-day solicited follow-up period.
Time frame: Day 31 (day of administration) to Day 45
Population: The analysis was performed on the ES. Only participants who experienced solicited systemic events after dose 2 administration for the specified duration were included in this analysis. Here, 'Number of Participants Analyzed' = participants with available data for solicited systemic events at dose 2.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Malaise | 2.5 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Arthralgia | 2.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Myalgia | 2.5 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Diarrhea | 1.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Fever | 1.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Fatigue | 2.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Headache | 1.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Chills | 1.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Loss of appetite | 1.0 Days |
| HBs-alum Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Nausea | 2.5 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Malaise | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Arthralgia | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Headache | 1.5 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Myalgia | 2.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Chills | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Loss of appetite | 2.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Fever | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Diarrhea | 1.5 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Nausea | 1.0 Days |
| HBs-AS03 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Fatigue | 2.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Headache | 1.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Diarrhea | 2.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Fatigue | 1.5 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Fever | 4.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Nausea | 1.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Malaise | 3.0 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Myalgia | 2.5 Days |
| HBs-AS04 Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Arthralgia | 1.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Malaise | 2.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Arthralgia | 5.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Chills | 1.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Diarrhea | 2.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Fatigue | 2.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Headache | 1.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Myalgia | 2.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Nausea | 2.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Fever | 1.0 Days |
| HBs-AS37B Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Vomiting | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Headache | 2.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Fatigue | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Fever | 2.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Nausea | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Diarrhea | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Chills | 1.5 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Arthralgia | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Malaise | 1.5 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Vomiting | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Myalgia | 1.0 Days |
| HBs-AS37A Group | Duration in Days of Solicited Systemic AEs After Dose 2 | Loss of appetite | 1.0 Days |
Primary
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1
In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC.
Time frame: At Day 31 (compared with baseline [prevaccination, Day 1])
Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 1 administration were available for the specified timepoint (at Day 31) were included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | ALT | -2.45 Mean percent change from baseline | Standard Deviation 32.837 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Potassium | -1.60 Mean percent change from baseline | Standard Deviation 6.867 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Erythrocytes | -2.30 Mean percent change from baseline | Standard Deviation 3.813 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Sodium | 0.18 Mean percent change from baseline | Standard Deviation 1.273 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Neutrophils | 10.63 Mean percent change from baseline | Standard Deviation 43.055 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Eosinophils | 61.95 Mean percent change from baseline | Standard Deviation 156.721 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Bicarbonate | 0.58 Mean percent change from baseline | Standard Deviation 11.02 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Monocytes | 8.76 Mean percent change from baseline | Standard Deviation 44.115 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Blood urea nitrogen | -1.04 Mean percent change from baseline | Standard Deviation 17.638 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | WBC | 6.65 Mean percent change from baseline | Standard Deviation 26.757 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Platelets | -4.21 Mean percent change from baseline | Standard Deviation 10.893 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Chloride | 0.76 Mean percent change from baseline | Standard Deviation 2.43 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | AST | -0.60 Mean percent change from baseline | Standard Deviation 22.151 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Lymphocytes | 3.44 Mean percent change from baseline | Standard Deviation 15.877 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | C Reactive Protein | 23.07 Mean percent change from baseline | Standard Deviation 94.084 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Hemoglobin | -1.99 Mean percent change from baseline | Standard Deviation 4.925 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Creatinine | -3.73 Mean percent change from baseline | Standard Deviation 8.529 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | C Reactive Protein | 37.95 Mean percent change from baseline | Standard Deviation 143.597 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Platelets | -1.86 Mean percent change from baseline | Standard Deviation 13.771 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Potassium | 0.23 Mean percent change from baseline | Standard Deviation 7.493 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Neutrophils | 2.47 Mean percent change from baseline | Standard Deviation 29.935 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | AST | 0.12 Mean percent change from baseline | Standard Deviation 25.394 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Eosinophils | 10.80 Mean percent change from baseline | Standard Deviation 47.476 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Hemoglobin | -0.25 Mean percent change from baseline | Standard Deviation 3.795 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Sodium | 0.49 Mean percent change from baseline | Standard Deviation 1.486 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Chloride | 0.29 Mean percent change from baseline | Standard Deviation 2.668 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | ALT | 12.52 Mean percent change from baseline | Standard Deviation 81.65 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Lymphocytes | 5.02 Mean percent change from baseline | Standard Deviation 23.147 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Bicarbonate | -2.47 Mean percent change from baseline | Standard Deviation 9.49 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | WBC | 2.37 Mean percent change from baseline | Standard Deviation 18.732 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Monocytes | 9.84 Mean percent change from baseline | Standard Deviation 30.487 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Erythrocytes | -0.71 Mean percent change from baseline | Standard Deviation 3.877 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Creatinine | -4.69 Mean percent change from baseline | Standard Deviation 9.817 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Blood urea nitrogen | 1.42 Mean percent change from baseline | Standard Deviation 23.387 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Erythrocytes | -1.14 Mean percent change from baseline | Standard Deviation 5.73 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | ALT | 2.94 Mean percent change from baseline | Standard Deviation 25.235 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | AST | 3.33 Mean percent change from baseline | Standard Deviation 31.456 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Bicarbonate | 0.78 Mean percent change from baseline | Standard Deviation 10.526 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Blood urea nitrogen | -5.65 Mean percent change from baseline | Standard Deviation 27.995 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Chloride | -0.16 Mean percent change from baseline | Standard Deviation 1.836 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | C Reactive Protein | 130.90 Mean percent change from baseline | Standard Deviation 518.895 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Creatinine | -1.37 Mean percent change from baseline | Standard Deviation 7.374 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Potassium | -0.78 Mean percent change from baseline | Standard Deviation 7.674 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Sodium | -0.28 Mean percent change from baseline | Standard Deviation 1.113 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Eosinophils | 6.13 Mean percent change from baseline | Standard Deviation 42.536 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Hemoglobin | -0.75 Mean percent change from baseline | Standard Deviation 5.168 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Lymphocytes | 4.16 Mean percent change from baseline | Standard Deviation 24.245 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Platelets | 1.72 Mean percent change from baseline | Standard Deviation 10.562 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Monocytes | 5.31 Mean percent change from baseline | Standard Deviation 30.151 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Neutrophils | 8.26 Mean percent change from baseline | Standard Deviation 27.07 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | WBC | 5.78 Mean percent change from baseline | Standard Deviation 20.17 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Potassium | 2.46 Mean percent change from baseline | Standard Deviation 8.75 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Creatinine | -1.77 Mean percent change from baseline | Standard Deviation 9.931 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Erythrocytes | 0.76 Mean percent change from baseline | Standard Deviation 4.317 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | C Reactive Protein | 12.48 Mean percent change from baseline | Standard Deviation 63.081 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Hemoglobin | 0.92 Mean percent change from baseline | Standard Deviation 4.328 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Chloride | 0.09 Mean percent change from baseline | Standard Deviation 2.059 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Lymphocytes | -0.47 Mean percent change from baseline | Standard Deviation 22.632 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Blood urea nitrogen | -3.27 Mean percent change from baseline | Standard Deviation 27.699 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | ALT | 5.89 Mean percent change from baseline | Standard Deviation 25.561 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Platelets | 2.92 Mean percent change from baseline | Standard Deviation 9.752 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Bicarbonate | -0.20 Mean percent change from baseline | Standard Deviation 9.834 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Monocytes | 7.75 Mean percent change from baseline | Standard Deviation 34.218 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | AST | 3.21 Mean percent change from baseline | Standard Deviation 22.04 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | WBC | -2.04 Mean percent change from baseline | Standard Deviation 18.832 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Sodium | 0.31 Mean percent change from baseline | Standard Deviation 1.221 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Neutrophils | -0.67 Mean percent change from baseline | Standard Deviation 24.74 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Eosinophils | 43.03 Mean percent change from baseline | Standard Deviation 99.613 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Eosinophils | 0.88 Mean percent change from baseline | Standard Deviation 44.64 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Platelets | 0.68 Mean percent change from baseline | Standard Deviation 10.344 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Bicarbonate | 4.65 Mean percent change from baseline | Standard Deviation 12.535 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Erythrocytes | -1.06 Mean percent change from baseline | Standard Deviation 5.496 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | C Reactive Protein | 77.00 Mean percent change from baseline | Standard Deviation 358.139 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Sodium | 0.13 Mean percent change from baseline | Standard Deviation 1.318 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Neutrophils | 12.13 Mean percent change from baseline | Standard Deviation 32.091 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | WBC | 6.17 Mean percent change from baseline | Standard Deviation 19.512 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Hemoglobin | -1.06 Mean percent change from baseline | Standard Deviation 4.325 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Chloride | 0.17 Mean percent change from baseline | Standard Deviation 2.022 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Creatinine | -2.23 Mean percent change from baseline | Standard Deviation 9.222 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | ALT | 3.07 Mean percent change from baseline | Standard Deviation 27.915 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Monocytes | 9.96 Mean percent change from baseline | Standard Deviation 29.752 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Lymphocytes | 0.61 Mean percent change from baseline | Standard Deviation 17.722 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Blood urea nitrogen | 3.70 Mean percent change from baseline | Standard Deviation 23.551 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | AST | 4.57 Mean percent change from baseline | Standard Deviation 21.93 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Potassium | -1.54 Mean percent change from baseline | Standard Deviation 6.611 |
Primary
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1
In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).
Time frame: At Day 8 (relative to baseline [pre-vaccination Day 1])
Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 1 administration were available for the specified timepoint (at Day 8) were included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | ALT | -3.04 Mean percent change from baseline | Standard Deviation 20.322 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Potassium | 1.88 Mean percent change from baseline | Standard Deviation 8.648 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Erythrocytes | -2.06 Mean percent change from baseline | Standard Deviation 3.756 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Sodium | 0.26 Mean percent change from baseline | Standard Deviation 1.204 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Neutrophils | 2.69 Mean percent change from baseline | Standard Deviation 27.341 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Eosinophils | 20.35 Mean percent change from baseline | Standard Deviation 45.285 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Bicarbonate | 0.52 Mean percent change from baseline | Standard Deviation 7.789 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Monocytes | 8.83 Mean percent change from baseline | Standard Deviation 23.264 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Blood urea nitrogen | 2.60 Mean percent change from baseline | Standard Deviation 29.717 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | WBC | 4.06 Mean percent change from baseline | Standard Deviation 16.847 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Platelets | 1.56 Mean percent change from baseline | Standard Deviation 10.141 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Chloride | 0.79 Mean percent change from baseline | Standard Deviation 1.921 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | AST | 4.74 Mean percent change from baseline | Standard Deviation 17.106 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Lymphocytes | 8.79 Mean percent change from baseline | Standard Deviation 18.849 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | C Reactive Protein | 78.43 Mean percent change from baseline | Standard Deviation 349.57 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Hemoglobin | -2.17 Mean percent change from baseline | Standard Deviation 3.729 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Creatinine | 0.34 Mean percent change from baseline | Standard Deviation 8.164 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | C Reactive Protein | 41.16 Mean percent change from baseline | Standard Deviation 124.844 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Platelets | 2.84 Mean percent change from baseline | Standard Deviation 7.234 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Potassium | -0.14 Mean percent change from baseline | Standard Deviation 8.133 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Neutrophils | -2.23 Mean percent change from baseline | Standard Deviation 28.41 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | AST | -5.62 Mean percent change from baseline | Standard Deviation 14.509 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Eosinophils | 31.51 Mean percent change from baseline | Standard Deviation 76.423 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Hemoglobin | -0.94 Mean percent change from baseline | Standard Deviation 3.817 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Sodium | 0.18 Mean percent change from baseline | Standard Deviation 1.376 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Chloride | 0.23 Mean percent change from baseline | Standard Deviation 2.119 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | ALT | -6.69 Mean percent change from baseline | Standard Deviation 14.117 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Lymphocytes | 6.58 Mean percent change from baseline | Standard Deviation 23.996 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Bicarbonate | -0.19 Mean percent change from baseline | Standard Deviation 8.276 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | WBC | 0.88 Mean percent change from baseline | Standard Deviation 17.754 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Monocytes | 6.20 Mean percent change from baseline | Standard Deviation 24.148 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Erythrocytes | -1.01 Mean percent change from baseline | Standard Deviation 3.786 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Creatinine | -2.35 Mean percent change from baseline | Standard Deviation 10.278 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Blood urea nitrogen | -3.03 Mean percent change from baseline | Standard Deviation 19.264 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Erythrocytes | -0.67 Mean percent change from baseline | Standard Deviation 4.423 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | ALT | -1.13 Mean percent change from baseline | Standard Deviation 34.221 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | AST | -1.79 Mean percent change from baseline | Standard Deviation 18.626 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Bicarbonate | 3.68 Mean percent change from baseline | Standard Deviation 8.491 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Blood urea nitrogen | 1.84 Mean percent change from baseline | Standard Deviation 32.456 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Chloride | -0.11 Mean percent change from baseline | Standard Deviation 2 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | C Reactive Protein | 129.65 Mean percent change from baseline | Standard Deviation 393.365 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Creatinine | -2.01 Mean percent change from baseline | Standard Deviation 7.209 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Potassium | 1.91 Mean percent change from baseline | Standard Deviation 8.313 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Sodium | 0.27 Mean percent change from baseline | Standard Deviation 1.438 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Eosinophils | -3.33 Mean percent change from baseline | Standard Deviation 46.839 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Hemoglobin | -0.60 Mean percent change from baseline | Standard Deviation 3.892 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Lymphocytes | 1.25 Mean percent change from baseline | Standard Deviation 25.224 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Platelets | 5.10 Mean percent change from baseline | Standard Deviation 10.605 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Monocytes | 7.31 Mean percent change from baseline | Standard Deviation 36.121 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Neutrophils | 14.24 Mean percent change from baseline | Standard Deviation 38.46 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | WBC | 7.58 Mean percent change from baseline | Standard Deviation 19.074 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Potassium | 2.43 Mean percent change from baseline | Standard Deviation 7.932 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Creatinine | -0.10 Mean percent change from baseline | Standard Deviation 9.989 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Erythrocytes | 0.45 Mean percent change from baseline | Standard Deviation 5.16 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | C Reactive Protein | 5.72 Mean percent change from baseline | Standard Deviation 57.451 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Hemoglobin | 0.74 Mean percent change from baseline | Standard Deviation 5.156 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Chloride | -0.33 Mean percent change from baseline | Standard Deviation 2.247 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Lymphocytes | 7.80 Mean percent change from baseline | Standard Deviation 32.898 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Blood urea nitrogen | 0.09 Mean percent change from baseline | Standard Deviation 25.501 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | ALT | 8.14 Mean percent change from baseline | Standard Deviation 25.853 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Platelets | 4.72 Mean percent change from baseline | Standard Deviation 10.952 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Bicarbonate | 0.06 Mean percent change from baseline | Standard Deviation 10.18 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Monocytes | 12.52 Mean percent change from baseline | Standard Deviation 35.758 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | AST | 7.35 Mean percent change from baseline | Standard Deviation 24.486 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | WBC | 0.26 Mean percent change from baseline | Standard Deviation 21.314 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Sodium | 0.04 Mean percent change from baseline | Standard Deviation 1.481 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Neutrophils | 2.03 Mean percent change from baseline | Standard Deviation 25.842 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Eosinophils | 18.15 Mean percent change from baseline | Standard Deviation 45.276 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Eosinophils | 12.86 Mean percent change from baseline | Standard Deviation 38.767 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Platelets | 5.67 Mean percent change from baseline | Standard Deviation 11.517 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Bicarbonate | 4.16 Mean percent change from baseline | Standard Deviation 7.337 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Erythrocytes | -0.21 Mean percent change from baseline | Standard Deviation 4.384 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | C Reactive Protein | -6.50 Mean percent change from baseline | Standard Deviation 45.671 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Sodium | 0.19 Mean percent change from baseline | Standard Deviation 1.253 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Neutrophils | 4.70 Mean percent change from baseline | Standard Deviation 28.444 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | WBC | 3.53 Mean percent change from baseline | Standard Deviation 18.126 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Hemoglobin | -0.36 Mean percent change from baseline | Standard Deviation 4.075 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Chloride | -0.24 Mean percent change from baseline | Standard Deviation 2.119 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Creatinine | 0.76 Mean percent change from baseline | Standard Deviation 9.176 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | ALT | 0.95 Mean percent change from baseline | Standard Deviation 15.926 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Monocytes | 4.98 Mean percent change from baseline | Standard Deviation 24.417 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Lymphocytes | 4.04 Mean percent change from baseline | Standard Deviation 15.252 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Blood urea nitrogen | -0.63 Mean percent change from baseline | Standard Deviation 15.543 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | AST | 2.28 Mean percent change from baseline | Standard Deviation 16.477 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 1 | Potassium | 0.27 Mean percent change from baseline | Standard Deviation 6.323 |
Primary
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2
In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC.
Time frame: At Day 38 (compared with baseline [pre-vaccination, Day 1])
Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 2 administration were available for the specified timepoint (at Day 38) were included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | ALT | -1.70 Mean percent change from baseline | Standard Deviation 28.091 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Potassium | -0.11 Mean percent change from baseline | Standard Deviation 8.188 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Erythrocytes | -2.59 Mean percent change from baseline | Standard Deviation 4.677 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Sodium | 0.31 Mean percent change from baseline | Standard Deviation 0.802 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Neutrophils | 8.11 Mean percent change from baseline | Standard Deviation 39.675 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Eosinophils | 103.21 Mean percent change from baseline | Standard Deviation 216.663 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Bicarbonate | -0.10 Mean percent change from baseline | Standard Deviation 11.002 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Monocytes | 20.33 Mean percent change from baseline | Standard Deviation 52.053 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Blood urea nitrogen | 2.83 Mean percent change from baseline | Standard Deviation 30.148 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | WBC | 5.34 Mean percent change from baseline | Standard Deviation 24.916 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Platelets | 1.41 Mean percent change from baseline | Standard Deviation 11.656 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Chloride | 0.39 Mean percent change from baseline | Standard Deviation 1.824 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | AST | 1.91 Mean percent change from baseline | Standard Deviation 26.199 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Lymphocytes | 2.35 Mean percent change from baseline | Standard Deviation 22.056 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | C Reactive Protein | 57.03 Mean percent change from baseline | Standard Deviation 191.211 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Hemoglobin | -1.89 Mean percent change from baseline | Standard Deviation 5.602 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Creatinine | 1.18 Mean percent change from baseline | Standard Deviation 10.007 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | C Reactive Protein | 131.87 Mean percent change from baseline | Standard Deviation 475.577 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Platelets | 5.25 Mean percent change from baseline | Standard Deviation 14.869 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Potassium | 0.30 Mean percent change from baseline | Standard Deviation 10.244 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Neutrophils | 10.17 Mean percent change from baseline | Standard Deviation 55.015 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | AST | -7.81 Mean percent change from baseline | Standard Deviation 21.151 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Eosinophils | 64.45 Mean percent change from baseline | Standard Deviation 142.771 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Hemoglobin | -0.44 Mean percent change from baseline | Standard Deviation 3.53 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Sodium | 0.32 Mean percent change from baseline | Standard Deviation 1.833 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Chloride | -0.18 Mean percent change from baseline | Standard Deviation 2.413 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | ALT | -9.56 Mean percent change from baseline | Standard Deviation 28.152 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Lymphocytes | 8.61 Mean percent change from baseline | Standard Deviation 23.233 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Bicarbonate | 1.04 Mean percent change from baseline | Standard Deviation 7.59 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | WBC | 8.19 Mean percent change from baseline | Standard Deviation 34.765 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Monocytes | 5.44 Mean percent change from baseline | Standard Deviation 29.929 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Erythrocytes | -0.54 Mean percent change from baseline | Standard Deviation 3.879 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Creatinine | -2.71 Mean percent change from baseline | Standard Deviation 8.546 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Blood urea nitrogen | -1.73 Mean percent change from baseline | Standard Deviation 23.632 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Erythrocytes | 0.01 Mean percent change from baseline | Standard Deviation 5.66 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | ALT | 8.70 Mean percent change from baseline | Standard Deviation 40.893 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | AST | 11.34 Mean percent change from baseline | Standard Deviation 41.922 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Bicarbonate | 4.41 Mean percent change from baseline | Standard Deviation 12.016 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Blood urea nitrogen | 2.30 Mean percent change from baseline | Standard Deviation 39.154 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Chloride | -0.96 Mean percent change from baseline | Standard Deviation 2.079 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | C Reactive Protein | 55.41 Mean percent change from baseline | Standard Deviation 110.35 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Creatinine | -0.25 Mean percent change from baseline | Standard Deviation 7.389 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Potassium | 1.76 Mean percent change from baseline | Standard Deviation 10.35 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Sodium | -0.03 Mean percent change from baseline | Standard Deviation 1.268 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Eosinophils | 27.38 Mean percent change from baseline | Standard Deviation 65.06 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Hemoglobin | -0.05 Mean percent change from baseline | Standard Deviation 5.064 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Lymphocytes | 15.80 Mean percent change from baseline | Standard Deviation 31.316 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Platelets | 6.56 Mean percent change from baseline | Standard Deviation 11.374 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Monocytes | 23.51 Mean percent change from baseline | Standard Deviation 31.162 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Neutrophils | 12.80 Mean percent change from baseline | Standard Deviation 27.43 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | WBC | 12.42 Mean percent change from baseline | Standard Deviation 18.141 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Potassium | 1.83 Mean percent change from baseline | Standard Deviation 8.246 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Creatinine | 0.61 Mean percent change from baseline | Standard Deviation 11.67 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Erythrocytes | 0.66 Mean percent change from baseline | Standard Deviation 4.466 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | C Reactive Protein | 146.04 Mean percent change from baseline | Standard Deviation 584.663 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Hemoglobin | 0.88 Mean percent change from baseline | Standard Deviation 4.548 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Chloride | -0.46 Mean percent change from baseline | Standard Deviation 2.004 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Lymphocytes | 2.46 Mean percent change from baseline | Standard Deviation 25.691 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Blood urea nitrogen | 0.69 Mean percent change from baseline | Standard Deviation 28.712 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | ALT | 7.81 Mean percent change from baseline | Standard Deviation 24.159 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Platelets | 2.33 Mean percent change from baseline | Standard Deviation 10.113 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Bicarbonate | 0.75 Mean percent change from baseline | Standard Deviation 9.389 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Monocytes | 10.00 Mean percent change from baseline | Standard Deviation 32.556 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | AST | 5.63 Mean percent change from baseline | Standard Deviation 17.43 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | WBC | -3.72 Mean percent change from baseline | Standard Deviation 16.095 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Sodium | 0.01 Mean percent change from baseline | Standard Deviation 1.225 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Neutrophils | -5.36 Mean percent change from baseline | Standard Deviation 24.208 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Eosinophils | 35.67 Mean percent change from baseline | Standard Deviation 96.666 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Eosinophils | 6.21 Mean percent change from baseline | Standard Deviation 58.498 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Platelets | 3.02 Mean percent change from baseline | Standard Deviation 14.577 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Bicarbonate | 5.04 Mean percent change from baseline | Standard Deviation 11.085 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Erythrocytes | -1.46 Mean percent change from baseline | Standard Deviation 5.741 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | C Reactive Protein | 3.02 Mean percent change from baseline | Standard Deviation 66.364 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Sodium | 0.38 Mean percent change from baseline | Standard Deviation 1.128 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Neutrophils | -3.26 Mean percent change from baseline | Standard Deviation 32.341 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | WBC | -3.79 Mean percent change from baseline | Standard Deviation 19.528 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Hemoglobin | -2.32 Mean percent change from baseline | Standard Deviation 3.201 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Chloride | 0.39 Mean percent change from baseline | Standard Deviation 2.058 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Creatinine | 1.40 Mean percent change from baseline | Standard Deviation 9.723 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | ALT | -4.15 Mean percent change from baseline | Standard Deviation 19.568 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Monocytes | 10.95 Mean percent change from baseline | Standard Deviation 42.691 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Lymphocytes | 0.10 Mean percent change from baseline | Standard Deviation 23.742 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Blood urea nitrogen | 5.34 Mean percent change from baseline | Standard Deviation 23.796 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | AST | -2.19 Mean percent change from baseline | Standard Deviation 18.087 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Potassium | 2.15 Mean percent change from baseline | Standard Deviation 7.425 |
Primary
Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2
In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC.
Time frame: At Day 61 (compared with baseline [pre-vaccination, Day 1])
Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data after dose 2 administration were available for the specified timepoint (at Day 61) were included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | ALT | -4.71 Mean percent change from baseline | Standard Deviation 27.145 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Potassium | 0.33 Mean percent change from baseline | Standard Deviation 9.316 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Erythrocytes | -0.86 Mean percent change from baseline | Standard Deviation 5.037 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Sodium | -0.35 Mean percent change from baseline | Standard Deviation 1.278 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Neutrophils | 3.81 Mean percent change from baseline | Standard Deviation 33.133 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Eosinophils | 20.20 Mean percent change from baseline | Standard Deviation 32.608 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Bicarbonate | 0.66 Mean percent change from baseline | Standard Deviation 8.676 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Monocytes | 21.95 Mean percent change from baseline | Standard Deviation 56.206 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Blood urea nitrogen | 8.26 Mean percent change from baseline | Standard Deviation 26.719 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | WBC | 5.16 Mean percent change from baseline | Standard Deviation 22.729 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Platelets | -1.29 Mean percent change from baseline | Standard Deviation 11.369 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Chloride | -0.22 Mean percent change from baseline | Standard Deviation 2.006 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | AST | 8.19 Mean percent change from baseline | Standard Deviation 43.555 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Lymphocytes | 6.43 Mean percent change from baseline | Standard Deviation 21.692 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | C Reactive Protein | 64.02 Mean percent change from baseline | Standard Deviation 180.495 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Hemoglobin | -0.86 Mean percent change from baseline | Standard Deviation 6.19 |
| HBs-alum Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Creatinine | 2.96 Mean percent change from baseline | Standard Deviation 13.01 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | C Reactive Protein | 121.89 Mean percent change from baseline | Standard Deviation 432.514 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Platelets | 2.12 Mean percent change from baseline | Standard Deviation 15.566 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Potassium | 3.34 Mean percent change from baseline | Standard Deviation 10.727 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Neutrophils | -6.10 Mean percent change from baseline | Standard Deviation 40.627 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | AST | 42.91 Mean percent change from baseline | Standard Deviation 171.398 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Eosinophils | 32.37 Mean percent change from baseline | Standard Deviation 59.533 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Hemoglobin | 0.49 Mean percent change from baseline | Standard Deviation 4.971 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Sodium | 0.34 Mean percent change from baseline | Standard Deviation 1.881 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Chloride | 0.48 Mean percent change from baseline | Standard Deviation 2.157 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | ALT | 61.39 Mean percent change from baseline | Standard Deviation 318.144 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Lymphocytes | 2.32 Mean percent change from baseline | Standard Deviation 18.547 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Bicarbonate | -2.36 Mean percent change from baseline | Standard Deviation 8.453 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | WBC | -3.20 Mean percent change from baseline | Standard Deviation 25.52 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Monocytes | 12.47 Mean percent change from baseline | Standard Deviation 32.131 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Erythrocytes | 0.65 Mean percent change from baseline | Standard Deviation 5.327 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Creatinine | -1.84 Mean percent change from baseline | Standard Deviation 13.034 |
| HBs-AS03 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Blood urea nitrogen | -1.24 Mean percent change from baseline | Standard Deviation 32.101 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Erythrocytes | -0.76 Mean percent change from baseline | Standard Deviation 5.901 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | ALT | 12.94 Mean percent change from baseline | Standard Deviation 49.927 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | AST | 18.51 Mean percent change from baseline | Standard Deviation 68.383 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Bicarbonate | 3.17 Mean percent change from baseline | Standard Deviation 9.88 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Blood urea nitrogen | -4.94 Mean percent change from baseline | Standard Deviation 21.078 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Chloride | 0.09 Mean percent change from baseline | Standard Deviation 1.691 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | C Reactive Protein | 79.61 Mean percent change from baseline | Standard Deviation 218.741 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Creatinine | 1.15 Mean percent change from baseline | Standard Deviation 11.041 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Potassium | -1.88 Mean percent change from baseline | Standard Deviation 7.115 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Sodium | 0.44 Mean percent change from baseline | Standard Deviation 1.278 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Eosinophils | 42.38 Mean percent change from baseline | Standard Deviation 91.92 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Hemoglobin | -0.85 Mean percent change from baseline | Standard Deviation 5.363 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Lymphocytes | 9.74 Mean percent change from baseline | Standard Deviation 32.46 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Platelets | 1.35 Mean percent change from baseline | Standard Deviation 12.342 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Monocytes | 15.05 Mean percent change from baseline | Standard Deviation 30.852 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Neutrophils | 8.68 Mean percent change from baseline | Standard Deviation 31.904 |
| HBs-AS04 Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | WBC | 9.32 Mean percent change from baseline | Standard Deviation 24.511 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Potassium | 1.17 Mean percent change from baseline | Standard Deviation 8.379 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Creatinine | -3.95 Mean percent change from baseline | Standard Deviation 8.215 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Erythrocytes | 0.51 Mean percent change from baseline | Standard Deviation 4.813 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | C Reactive Protein | 91.49 Mean percent change from baseline | Standard Deviation 237.304 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Hemoglobin | 0.60 Mean percent change from baseline | Standard Deviation 4.671 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Chloride | -0.14 Mean percent change from baseline | Standard Deviation 2.311 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Lymphocytes | -1.74 Mean percent change from baseline | Standard Deviation 27.336 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Blood urea nitrogen | -2.00 Mean percent change from baseline | Standard Deviation 25.429 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | ALT | 4.67 Mean percent change from baseline | Standard Deviation 36.939 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Platelets | 3.77 Mean percent change from baseline | Standard Deviation 10.156 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Bicarbonate | -3.21 Mean percent change from baseline | Standard Deviation 10.373 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Monocytes | 5.66 Mean percent change from baseline | Standard Deviation 35.371 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | AST | 8.78 Mean percent change from baseline | Standard Deviation 47.643 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | WBC | 0.84 Mean percent change from baseline | Standard Deviation 24.001 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Sodium | -0.33 Mean percent change from baseline | Standard Deviation 1.156 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Neutrophils | 4.91 Mean percent change from baseline | Standard Deviation 34.72 |
| HBs-AS37B Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Eosinophils | 57.74 Mean percent change from baseline | Standard Deviation 144.539 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Eosinophils | 17.59 Mean percent change from baseline | Standard Deviation 63.368 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Platelets | 3.47 Mean percent change from baseline | Standard Deviation 11.839 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Bicarbonate | 4.64 Mean percent change from baseline | Standard Deviation 12.554 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Erythrocytes | -0.63 Mean percent change from baseline | Standard Deviation 5.596 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | C Reactive Protein | 109.50 Mean percent change from baseline | Standard Deviation 512.035 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Sodium | 0.25 Mean percent change from baseline | Standard Deviation 1.335 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Neutrophils | 12.12 Mean percent change from baseline | Standard Deviation 42.077 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | WBC | 7.14 Mean percent change from baseline | Standard Deviation 25.18 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Hemoglobin | -1.01 Mean percent change from baseline | Standard Deviation 3.466 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Chloride | 0.01 Mean percent change from baseline | Standard Deviation 1.803 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Creatinine | -1.20 Mean percent change from baseline | Standard Deviation 7.048 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | ALT | 13.83 Mean percent change from baseline | Standard Deviation 63.7 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Monocytes | 15.01 Mean percent change from baseline | Standard Deviation 42.423 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Lymphocytes | 4.92 Mean percent change from baseline | Standard Deviation 21.356 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Blood urea nitrogen | 2.60 Mean percent change from baseline | Standard Deviation 21.312 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | AST | 3.47 Mean percent change from baseline | Standard Deviation 33.308 |
| HBs-AS37A Group | Mean Percent Change From Baseline (Pre-vaccination, Day 1) in Hematology and Biochemistry Parameters Post-dose 2 | Potassium | -0.21 Mean percent change from baseline | Standard Deviation 6.832 |
Primary
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1
In the analysis were included biochemistry parameters: ALT, AST, bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, WBC. Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 1 (baseline)
Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 1) were included in analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Above | 3 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Within | 25 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Within | 25 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Within | 25 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Below | 3 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Within | 25 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Within | 25 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Within | 25 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Within | 25 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Below | 3 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Within | 21 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Within | 21 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Above | 4 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Above | 4 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Above | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Within | 21 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Above | 3 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Below | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Above | 3 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Below | 3 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Below | 5 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Within | 19 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Above | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Below | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Above | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Within | 22 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Below | 3 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Within | 21 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Within | 22 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Below | 3 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Above | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Below | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Below | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Above | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Within | 20 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Above | 3 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | ALT | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | WBC | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Creatinine | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Neutrophils | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Potassium | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Within | 20 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Erythrocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Monocytes | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Sodium | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Below | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Platelets | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Bicarbonate, Day 1 | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Eosinophils | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Lymphocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Hemoglobin | Below | 3 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | Chloride | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 1 | AST | Within | 22 Participants |
Primary
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31
In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 31
Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 31) were included in analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Above | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Above | 5 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Within | 19 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Above | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Within | 21 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Below | 3 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Above | 3 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Within | 19 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Above | 5 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Above | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Within | 17 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Above | 6 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Below | 5 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Within | 18 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Below | 5 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Within | 17 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Below | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Within | 22 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Within | 22 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Within | 21 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Within | 22 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Below | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Below | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Below | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Within | 21 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Above | 3 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Within | 22 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Above | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Below | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Above | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Below | 4 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Above | 3 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Within | 19 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Within | 20 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | C Reactive Protein | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Hemoglobin | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Chloride | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Lymphocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Above | 3 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Within | 20 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Platelets | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | ALT | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Bicarbonate | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Monocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Below | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Sodium | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Neutrophils | Within | 20 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Erythrocytes | Below | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | AST | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Potassium | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | WBC | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Eosinophils | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 31 | Creatinine | Missing | 0 Participants |
Primary
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38
In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 38
Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 38) were included in analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Missing | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Within | 21 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Missing | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Above | 4 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Within | 18 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Missing | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Within | 19 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Below | 3 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Below | 3 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Above | 4 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Missing | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Within | 21 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Within | 19 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Within | 19 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Within | 20 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Below | 3 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Missing | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Within | 21 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Within | 21 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Above | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Within | 19 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Below | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Above | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Above | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Within | 21 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Within | 20 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Above | 3 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Within | 19 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Above | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Below | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Within | 20 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Within | 20 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Within | 17 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Above | 5 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Within | 20 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Below | 6 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Within | 16 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Within | 20 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Below | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Below | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Above | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Below | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Above | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Below | 5 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Within | 18 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Creatinine | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Hemoglobin | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Above | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | C Reactive Protein | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Lymphocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Chloride | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Platelets | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Monocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | WBC | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Bicarbonate | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Sodium | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | ALT | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Eosinophils | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Neutrophils | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Potassium | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | Erythrocytes | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 38 | AST | Above | 0 Participants |
Primary
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61
In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 61
Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 61) were included in analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Within | 20 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Above | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Above | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Above | 3 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Within | 20 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Missing | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Above | 4 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Within | 21 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Within | 19 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Above | 3 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Within | 21 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Missing | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Within | 21 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Below | 4 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Within | 21 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Within | 20 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Within | 21 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Above | 3 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Above | 3 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Above | 4 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Within | 21 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Above | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Above | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Below | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Within | 21 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Above | 3 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Within | 21 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Above | 3 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Within | 21 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Within | 17 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Above | 5 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Missing | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Below | 4 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Within | 19 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Below | 5 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Within | 18 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Above | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Within | 22 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Below | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Within | 21 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Below | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Below | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Within | 21 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Below | 4 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Below | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Above | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Within | 22 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Below | 3 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Below | 3 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Above | 3 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Within | 20 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Within | 20 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | C Reactive Protein | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Hemoglobin | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Chloride | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Lymphocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Above | 3 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Platelets | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Erythrocytes | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | ALT | Within | 20 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Bicarbonate | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Monocytes | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Below | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Sodium | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Neutrophils | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | AST | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Potassium | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Eosinophils | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | Creatinine | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 61 | WBC | Above | 1 Participants |
Primary
Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8
In the analysis were included biochemistry parameters: alanine aminotransferase (ALT), aspartate transaminase (AST), bicarbonate, blood urea nitrogen, chloride, C reactive protein, creatinine, potassium, sodium; and hematology parameters: eosinophils, erythrocytes, hemoglobin, lymphocytes, platelets, monocytes, neutrophils, white blood cells (WBC).Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.
Time frame: At Day 8
Population: The analysis was performed on the ES. Only participants for whom the specified laboratory data were available for the specified timepoint (Day 8) were included in analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Below | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Within | 25 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Above | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Above | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Within | 25 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Within | 22 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Within | 25 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Below | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Above | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Above | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Below | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Within | 20 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Within | 23 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Within | 24 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Below | 4 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Above | 2 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Missing | 1 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Missing | 0 Participants |
| HBs-alum Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Above | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Above | 3 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Within | 23 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Above | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Below | 1 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Above | 2 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Above | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Above | 3 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Within | 25 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Within | 24 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Missing | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Below | 0 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Within | 22 Participants |
| HBs-AS03 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Within | 21 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Above | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Above | 3 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Below | 2 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Below | 5 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Within | 19 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Missing | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Below | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Within | 24 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Within | 22 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Above | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Missing | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Below | 1 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Within | 23 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Above | 0 Participants |
| HBs-AS04 Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Below | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Within | 23 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Within | 22 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Below | 2 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Below | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Within | 21 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Above | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Above | 3 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Within | 25 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Missing | 1 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Within | 24 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Missing | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Above | 0 Participants |
| HBs-AS37B Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Above | 3 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Within | 20 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Missing | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Creatinine | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Below | 3 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Within | 19 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Above | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Missing | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Hemoglobin | Missing | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Chloride | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Lymphocytes | Missing | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Above | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Missing | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Platelets | Missing | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Within | 20 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | ALT | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Blood urea nitrogen | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Bicarbonate | Below | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | C Reactive Protein | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Within | 22 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Above | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Sodium | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Missing | 0 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Neutrophils | Within | 21 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Below | 2 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Erythrocytes | Below | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | AST | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Within | 19 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Monocytes | Missing | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Within | 23 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | WBC | Above | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Eosinophils | Missing | 1 Participants |
| HBs-AS37A Group | Number of Participants With Abnormal Hematology and Biochemistry Laboratory Parameter Values at Day 8 | Potassium | Below | 0 Participants |
Primary
Number of Participants With AEs Leading to Study Withdrawal
An AE is any untoward medical occurrence (an unfavourable/unintended sign - including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant that is temporally associated with the study intervention. The AE may or may not be considered related to the study intervention. A participant is considered to have withdrawn from the study if no new study procedure has been performed or no new information has been collected for him/her since the date of withdrawal/last contact.
Time frame: Throughout the entire study period (from Day 1 to Day 361)
Population: The analysis was performed on the ES.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBs-alum Group | Number of Participants With AEs Leading to Study Withdrawal | 0 Participants |
| HBs-AS03 Group | Number of Participants With AEs Leading to Study Withdrawal | 0 Participants |
| HBs-AS04 Group | Number of Participants With AEs Leading to Study Withdrawal | 0 Participants |
| HBs-AS37B Group | Number of Participants With AEs Leading to Study Withdrawal | 0 Participants |
| HBs-AS37A Group | Number of Participants With AEs Leading to Study Withdrawal | 0 Participants |
Primary
Number of Participants With Any Unsolicited AEs After Dose 1
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non-serious AEs. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 1 (day of administration) to Day 31
Population: The analysis was performed on the ES. Only participants with unsolicited AEs after dose 1 administration for the specified duration were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBs-alum Group | Number of Participants With Any Unsolicited AEs After Dose 1 | 7 Participants |
| HBs-AS03 Group | Number of Participants With Any Unsolicited AEs After Dose 1 | 2 Participants |
| HBs-AS04 Group | Number of Participants With Any Unsolicited AEs After Dose 1 | 6 Participants |
| HBs-AS37B Group | Number of Participants With Any Unsolicited AEs After Dose 1 | 4 Participants |
| HBs-AS37A Group | Number of Participants With Any Unsolicited AEs After Dose 1 | 5 Participants |
Primary
Number of Participants With Any Unsolicited AEs After Dose 2
Any = occurrence of the event regardless of intensity grade or relation to the study vaccination.
Time frame: Day 31 (day of administration) to Day 61
Population: The analysis was performed on the ES. Only participants with unsolicited AEs after dose 2 administration for the specified duration were included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBs-alum Group | Number of Participants With Any Unsolicited AEs After Dose 2 | 5 Participants |
| HBs-AS03 Group | Number of Participants With Any Unsolicited AEs After Dose 2 | 7 Participants |
| HBs-AS04 Group | Number of Participants With Any Unsolicited AEs After Dose 2 | 6 Participants |
| HBs-AS37B Group | Number of Participants With Any Unsolicited AEs After Dose 2 | 6 Participants |
| HBs-AS37A Group | Number of Participants With Any Unsolicited AEs After Dose 2 | 6 Participants |
Primary
Number of Participants With Medically Attended AEs (MAEs)
An MAE is any AE with medically attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of the MAE regardless of intensity grade or relation to the study vaccination.
Time frame: Throughout the entire study period (from Day 1 to Day 361)
Population: The analysis was performed on the ES.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBs-alum Group | Number of Participants With Medically Attended AEs (MAEs) | 8 Participants |
| HBs-AS03 Group | Number of Participants With Medically Attended AEs (MAEs) | 2 Participants |
| HBs-AS04 Group | Number of Participants With Medically Attended AEs (MAEs) | 2 Participants |
| HBs-AS37B Group | Number of Participants With Medically Attended AEs (MAEs) | 3 Participants |
| HBs-AS37A Group | Number of Participants With Medically Attended AEs (MAEs) | 4 Participants |
Primary
Number of Participants With Potential Mediated Immune Diseases (pIMDs)
pIMDs are a subset of adverse events that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune aetiology. Any = occurrence of the pIMD regardless of intensity grade or relation to the study vaccination.
Time frame: Throughout the entire study period (from Day 1 to Day 361)
Population: The analysis was performed on the ES.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBs-alum Group | Number of Participants With Potential Mediated Immune Diseases (pIMDs) | 0 Participants |
| HBs-AS03 Group | Number of Participants With Potential Mediated Immune Diseases (pIMDs) | 0 Participants |
| HBs-AS04 Group | Number of Participants With Potential Mediated Immune Diseases (pIMDs) | 0 Participants |
| HBs-AS37B Group | Number of Participants With Potential Mediated Immune Diseases (pIMDs) | 1 Participants |
| HBs-AS37A Group | Number of Participants With Potential Mediated Immune Diseases (pIMDs) | 0 Participants |
Primary
Number of Participants With Serious AEs (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or is an abnormal pregnancy outcome. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination.
Time frame: Throughout the entire study period (from Day 1 to Day 361)
Population: The analysis was performed on the ES.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HBs-alum Group | Number of Participants With Serious AEs (SAEs) | 0 Participants |
| HBs-AS03 Group | Number of Participants With Serious AEs (SAEs) | 0 Participants |
| HBs-AS04 Group | Number of Participants With Serious AEs (SAEs) | 0 Participants |
| HBs-AS37B Group | Number of Participants With Serious AEs (SAEs) | 1 Participants |
| HBs-AS37A Group | Number of Participants With Serious AEs (SAEs) | 0 Participants |
Primary
Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1
Assessed solicited administration site events after vaccination included erythema, pain, and swelling at the injection site. Any = occurrence of the event regardless of intensity grade.
Time frame: Day 1 (day of administration) to Day 14
Population: The analysis was performed on the Exposed Set (ES), which included all participants who received at least 1 dose of the study intervention. Only participants with solicited administration site events diary card available after dose 1 administration for the specified duration were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBs-alum Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Pain | 6 Participants |
| HBs-alum Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Erythema | 0 Participants |
| HBs-alum Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Swelling | 0 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Pain | 17 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Erythema | 0 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Swelling | 0 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Pain | 21 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Erythema | 0 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Swelling | 0 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Erythema | 0 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Pain | 16 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Swelling | 0 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Pain | 18 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Swelling | 0 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Administration Site Adverse Events (AEs) After Dose 1 | Erythema | 0 Participants |
Primary
Number of Participants With Solicited Administration Site AEs After Dose 2
Assessed solicited administration site events after vaccination included erythema, pain and swelling at the injection site. Any = occurrence of the event regardless of intensity grade.
Time frame: Day 31 (day of administration) to Day 45
Population: The analysis was performed on the ES. Only participants with solicited administration site events diary card available after dose 2 administration for the specified duration were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBs-alum Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Erythema | 0 Participants |
| HBs-alum Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Swelling | 0 Participants |
| HBs-alum Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Pain | 1 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Pain | 15 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Erythema | 0 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Swelling | 0 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Pain | 16 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Erythema | 0 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Swelling | 0 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Erythema | 0 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Swelling | 0 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Pain | 14 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Pain | 14 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Erythema | 0 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Administration Site AEs After Dose 2 | Swelling | 0 Participants |
Primary
Number of Participants With Solicited Systemic AEs After Dose 1
Assessed solicited systemic events included fever (defined as temperature greater than or equal to (\>=) 38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea.
Time frame: Day 1 (day of administration) to Day 14
Population: The analysis was performed on the ES. Only participants with solicited systemic events diary card available after dose 1 administration for the specified duration were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Arthralgia | 1 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Fever | 1 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Loss of appetite | 1 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Nausea | 6 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Diarrhea | 3 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Headache | 8 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Vomiting | 0 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Malaise | 8 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Myalgia | 8 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Fatigue | 9 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Chills | 2 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Fatigue | 10 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Malaise | 2 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Loss of appetite | 4 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Arthralgia | 2 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Fever | 2 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Chills | 0 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Nausea | 0 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Diarrhea | 2 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Headache | 9 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Myalgia | 6 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Vomiting | 0 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Chills | 0 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Headache | 8 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Arthralgia | 2 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Diarrhea | 4 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Fatigue | 10 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Loss of appetite | 2 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Malaise | 7 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Myalgia | 14 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Nausea | 3 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Fever | 1 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Vomiting | 0 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Malaise | 3 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Diarrhea | 0 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Myalgia | 7 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Chills | 1 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Nausea | 1 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Headache | 10 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Vomiting | 0 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Fever | 2 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Loss of appetite | 1 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Fatigue | 12 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Arthralgia | 2 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Nausea | 1 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Malaise | 2 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Diarrhea | 2 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Fever | 0 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Fatigue | 11 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Arthralgia | 1 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Myalgia | 9 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Chills | 1 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Headache | 10 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Vomiting | 0 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 1 | Loss of appetite | 0 Participants |
Primary
Number of Participants With Solicited Systemic AEs After Dose 2
Assessed solicited systemic events included fever (defined as temperature \>=38.0°C regardless of the location of measurement), fatigue, myalgia, arthralgia, headache, chills, malaise, loss of appetite, nausea, vomiting, and diarrhea.
Time frame: Day 31 (day of administration) to Day 45
Population: The analysis was performed on the ES. Only participants with solicited systemic events diary card available after dose 2 administration for the specified duration were included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Loss of appetite | 3 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Malaise | 6 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Arthralgia | 2 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Nausea | 2 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Fatigue | 9 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Fever | 1 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Vomiting | 0 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Diarrhea | 3 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Myalgia | 2 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Headache | 9 Participants |
| HBs-alum Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Chills | 2 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Headache | 8 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Malaise | 7 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Loss of appetite | 2 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Chills | 4 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Arthralgia | 3 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Fever | 1 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Diarrhea | 2 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Vomiting | 0 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Nausea | 1 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Fatigue | 8 Participants |
| HBs-AS03 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Myalgia | 7 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Loss of appetite | 0 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Arthralgia | 1 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Chills | 0 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Diarrhea | 1 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Fatigue | 8 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Headache | 7 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Malaise | 1 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Myalgia | 12 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Nausea | 3 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Fever | 1 Participants |
| HBs-AS04 Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Vomiting | 0 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Fatigue | 7 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Arthralgia | 1 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Chills | 1 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Vomiting | 1 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Fever | 1 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Diarrhea | 1 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Loss of appetite | 0 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Myalgia | 6 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Nausea | 1 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Headache | 7 Participants |
| HBs-AS37B Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Malaise | 3 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Arthralgia | 1 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Malaise | 2 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Fatigue | 5 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Myalgia | 7 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Diarrhea | 1 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Vomiting | 1 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Nausea | 2 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Chills | 2 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Fever | 1 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Loss of appetite | 1 Participants |
| HBs-AS37A Group | Number of Participants With Solicited Systemic AEs After Dose 2 | Headache | 4 Participants |
Secondary
Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations
Anti-HBs antibody concentration was measured as GMC and expressed in milli international units per milliliter (mIU/mL).
Time frame: At Day 1, Day 31, Day 61 and Day 361
Population: The analysis was performed on the Per-Protocol set (PPS), which included all participants who received all doses as per protocol, had immunogenicity results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. Only participants with data available for GMC of anti-HBs antibody concentration at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HBs-alum Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 31 | 7.7 mIU/mL |
| HBs-alum Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 1 | 3.4 mIU/mL |
| HBs-alum Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 361 | 1055.9 mIU/mL |
| HBs-alum Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 61 | 40.3 mIU/mL |
| HBs-AS03 Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 1 | 3.1 mIU/mL |
| HBs-AS03 Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 31 | 204.9 mIU/mL |
| HBs-AS03 Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 61 | 7193.0 mIU/mL |
| HBs-AS03 Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 361 | 3211.8 mIU/mL |
| HBs-AS04 Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 31 | 8.3 mIU/mL |
| HBs-AS04 Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 61 | 86.3 mIU/mL |
| HBs-AS04 Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 1 | 3.1 mIU/mL |
| HBs-AS04 Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 361 | 41.4 mIU/mL |
| HBs-AS37B Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 31 | 22.0 mIU/mL |
| HBs-AS37B Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 1 | 3.1 mIU/mL |
| HBs-AS37B Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 61 | 401.3 mIU/mL |
| HBs-AS37B Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 361 | 153.2 mIU/mL |
| HBs-AS37A Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 31 | 95.2 mIU/mL |
| HBs-AS37A Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 1 | 3.1 mIU/mL |
| HBs-AS37A Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 61 | 1574.2 mIU/mL |
| HBs-AS37A Group | Geometric Mean Concentration (GMC) of Anti-HBs Antibody Concentrations | Day 361 | 586.3 mIU/mL |
Secondary
Percentage of Participants Seroprotected for Anti-HBs
A participant seroprotected for anti-HBs is defined as a participant with an anti-HBs antibody concentration \>10 mIU/mL.
Time frame: At Day 31, Day 61 and Day 361
Population: The analysis was performed on the PPS. Only participants that were seroprotected for anti-HBs and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBs-alum Group | Percentage of Participants Seroprotected for Anti-HBs | Day 31 | 16.7 Percentage of participants |
| HBs-alum Group | Percentage of Participants Seroprotected for Anti-HBs | Day 361 | 95.2 Percentage of participants |
| HBs-alum Group | Percentage of Participants Seroprotected for Anti-HBs | Day 61 | 62.5 Percentage of participants |
| HBs-AS03 Group | Percentage of Participants Seroprotected for Anti-HBs | Day 61 | 100 Percentage of participants |
| HBs-AS03 Group | Percentage of Participants Seroprotected for Anti-HBs | Day 31 | 95.5 Percentage of participants |
| HBs-AS03 Group | Percentage of Participants Seroprotected for Anti-HBs | Day 361 | 100 Percentage of participants |
| HBs-AS04 Group | Percentage of Participants Seroprotected for Anti-HBs | Day 61 | 87.0 Percentage of participants |
| HBs-AS04 Group | Percentage of Participants Seroprotected for Anti-HBs | Day 31 | 21.7 Percentage of participants |
| HBs-AS04 Group | Percentage of Participants Seroprotected for Anti-HBs | Day 361 | 72.7 Percentage of participants |
| HBs-AS37B Group | Percentage of Participants Seroprotected for Anti-HBs | Day 31 | 59.1 Percentage of participants |
| HBs-AS37B Group | Percentage of Participants Seroprotected for Anti-HBs | Day 361 | 100 Percentage of participants |
| HBs-AS37B Group | Percentage of Participants Seroprotected for Anti-HBs | Day 61 | 100 Percentage of participants |
| HBs-AS37A Group | Percentage of Participants Seroprotected for Anti-HBs | Day 61 | 100 Percentage of participants |
| HBs-AS37A Group | Percentage of Participants Seroprotected for Anti-HBs | Day 31 | 81.0 Percentage of participants |
| HBs-AS37A Group | Percentage of Participants Seroprotected for Anti-HBs | Day 361 | 100 Percentage of participants |
Secondary
Percentage of Participants Who Seroconverted for Anti-HBs
A participant who seroconverted for anti-HBs is defined as a participant with an anti-HBs antibody concentration higher than (\>) 6.2 mIU/mL.
Time frame: At Day 31, Day 61 and Day 361
Population: The analysis was performed on the PPS. Only participants that seroconverted for anti-HBs and had data available at the specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HBs-alum Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 31 | 16.7 Percentage of participants |
| HBs-alum Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 361 | 95.2 Percentage of participants |
| HBs-alum Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 61 | 75.0 Percentage of participants |
| HBs-AS03 Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 61 | 100 Percentage of participants |
| HBs-AS03 Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 31 | 95.5 Percentage of participants |
| HBs-AS03 Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 361 | 100 Percentage of participants |
| HBs-AS04 Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 61 | 87.0 Percentage of participants |
| HBs-AS04 Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 31 | 21.7 Percentage of participants |
| HBs-AS04 Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 361 | 72.7 Percentage of participants |
| HBs-AS37B Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 31 | 59.1 Percentage of participants |
| HBs-AS37B Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 361 | 100 Percentage of participants |
| HBs-AS37B Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 61 | 100 Percentage of participants |
| HBs-AS37A Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 61 | 100 Percentage of participants |
| HBs-AS37A Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 31 | 81.0 Percentage of participants |
| HBs-AS37A Group | Percentage of Participants Who Seroconverted for Anti-HBs | Day 361 | 100 Percentage of participants |