Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| HHSN272201000035C | Other Grant/Funding Number | National Institute of Allergy and Infectious Diseases |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.
The safety and immunogenicity of AV7909 for post-exposure prophylaxis of anthrax will be evaluated using a randomized, parallel-group, active-controlled, double-blind design with three immunization schedules and two dose levels in healthy adult volunteers. Safety will be assessed by clinical laboratory tests (hematology, serum chemistry, and urinalysis), monitoring of adverse events, vital signs, and physical examinations. Reactogenicity (systemic and injection site reactions) will be assessed by the subjects using subject e-diaries for 7 days after each immunization and by the investigator at in-clinic visits 7 and 14 days after each immunization, and at other visits, if applicable. Immunogenicity will be measured as toxin neutralizing antibody (TNA) response and seroconversion rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AV7909 (Day 0 and 14) | Experimental | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 |
|
| AV7909 (Day 0 and 28) | Experimental | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 |
|
| AV7909 (Day 0, 14, and 28) | Experimental | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 |
|
| AV7909 Reduced Dose | Experimental | Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 |
|
| BioThrax | Active Comparator | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AV7909 | Biological | Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Toxin Neutralizing Antibody (TNA) Level at Day 63 | Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold | Day 63 |
| Incidence of Adverse Events | Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84 | From the time of the first immunization on Day 0 through Day 84 |
| Incidence of Serious Adverse Events | Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination | From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination |
| Incidence of Reactogenicity By Severity | Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity. Reactions were graded using the following scale (note, for redness and swelling, the diameter [greater of two perpendicular measurements] was assessed by the subject using an injection site measurement tool): Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures <3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 - 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures > 10 cm. For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity. | For 7 days following each vaccination on Days 0, 14, 28 |
| Measure | Description | Time Frame |
|---|---|---|
| TNA Level at Day 42 | Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold | Day 42 |
| TNA Level at Day 28 | Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gurdyal Kalsi, MD, MTOPRA | Emergent BioSolutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates | Miami | Florida | 33143 | United States | ||
| Costal Carolina Research |
All 168 enrolled participants who met eligibility criteria were dosed.
Participants were enrolled from 16 January 2013 to 14 November 2013 at 4 medical centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | AV7909 (Day 0 and 14) | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| FG001 | AV7909 (Day 0 and 28) | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| FG002 | AV7909 (Day 0, 14, and 28) | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| FG003 | AV7909 Reduced Dose | Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| FG004 | BioThrax | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat Population
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AV7909 (Day 0 and 14) | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| BG001 | AV7909 (Day 0 and 28) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Toxin Neutralizing Antibody (TNA) Level at Day 63 | Immunogenicity measured by the lower bound (LB) of the 95% confidence intervals (CIs) for the proportion of subjects in each study arm with Day 63 TNA 50% neutralization factor (NF50) values greater than or equal to threshold | Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data). | Posted | Mean | 95% Confidence Interval | percentage of participants | Day 63 |
|
From signing of the ICF to the first immunization on Day 0 (AEs recorded only if resulting from a study-related procedure) then through Day 84.
AEs were collected at study visits on Days 0, 7, 14, 21, 28, 35, 42, 49, 63, and 84, and at the early withdrawal visit. The occurrence of SAEs and adverse events of special interest (autoimmune-related) were collected at safety follow-up phone contacts at 6 and 12 months following the last scheduled vaccination.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AV7909 (Day 0 and 14) | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment | cellulitis secondary to animal bite |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
A few events collected in e-diary were downgraded (severe to moderate) on verification by the PI but were unable to be corrected in subjects' e-diary data: headache & fatigue/tenderness in 2 subjects each; muscle ache & pain & AML in 1 subject each.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gurdyal Kalsi | Emergent BioSolutions | 301-216-9927 | kalsig@ebsi.com |
Not provided
| ID | Term |
|---|---|
| D000881 | Anthrax |
| ID | Term |
|---|---|
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| C493276 | Biothrax |
| D022122 | Anthrax Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
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|
| BioThrax | Biological |
|
|
| Incidence of Clinical Laborabory Abnormalities | Incidence of clinical laboratory abnormalities throughout the study (up to Day 84). Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality. | From the time of first immunization on Day 0 to Day 84 |
| Incidence of Immunologically Significant Adverse Events of Special Interest | Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination | From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination |
| Day 28 |
| TNA Seroconversion Rate | Immunogenicity measured by the percentage of subjects who have seroconverted (defined as a 4-fold increase over Day 0 in TNA NF50 value) at Days 21, 28, 35, 42, 49, 63, and 84 | Up to Day 84 |
| Mt. Pleasant |
| South Carolina |
| 29464 |
| United States |
| Central Texas Allergy and Asthma | New Braunfels | Texas | 78130 | United States |
| Jean Brown Research | Salt Lake City | Utah | 84124 | United States |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Sponsor Terminated Subject |
|
| Moving Out of State |
|
Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28
AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant
| BG002 | AV7909 (Day 0, 14, and 28) | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| BG003 | AV7909 Reduced Dose | Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| BG004 | BioThrax | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | AV7909 (Day 0 and 28) | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| OG002 | AV7909 (Day 0, 14, and 28) | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| OG003 | AV7909 Reduced Dose | Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant |
| OG004 | BioThrax | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax |
|
|
| Primary | Incidence of Adverse Events | Incidence of adverse events (including assessment of symptoms, physical exam findings, clinical laboratory tests, and vital signs) from the time of the first immunization on Day 0 through Day 84 | Safety Population (subjects who received at least one dose of IMP) | Posted | Number | participants | From the time of the first immunization on Day 0 through Day 84 |
|
|
|
| Secondary | TNA Level at Day 42 | Immunogenicity measured by the percentage of subjects in each study arm with Day 42 TNA NF50 values greater than or equal to threshold | Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data). | Posted | Mean | 95% Confidence Interval | percentage of participants | Day 42 |
|
|
|
| Secondary | TNA Level at Day 28 | Immunogenicity measured by the percentage of subjects with Day 28 TNA NF50 values greater than or equal to threshold | Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data). | Posted | Mean | 95% Confidence Interval | percentage of participants | Day 28 |
|
|
|
| Secondary | TNA Seroconversion Rate | Immunogenicity measured by the percentage of subjects who have seroconverted (defined as a 4-fold increase over Day 0 in TNA NF50 value) at Days 21, 28, 35, 42, 49, 63, and 84 | Per-protocol Population at Day 63 (randomized subjects who did not have any deviation of 1) history of anthrax vaccination; 2) missing or out of window vaccination at Day 14 or 28; 3) incorrect IMP dose at one or more visits; 4) IMP dose associated with a temperature excursion; 5) prohibited medications; or 6) missing Day 63 immunogenicity data). | Posted | Mean | 95% Confidence Interval | percentage of participants | Up to Day 84 |
|
|
|
| Primary | Incidence of Serious Adverse Events | Incidence of serious adverse events, from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination | Safety Population (subjects who received at least one dose of IMP) | Posted | Number | participants | From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination |
|
|
|
| Primary | Incidence of Reactogenicity By Severity | Incidence of solicited systemic reactions and solicited injection site reactions each day for 7 days following each vaccination using subject e-diaries by severity. Reactions were graded using the following scale (note, for redness and swelling, the diameter [greater of two perpendicular measurements] was assessed by the subject using an injection site measurement tool): Grade 0 (Absent): Symptom not present; Grade 1 (Mild): Symptom present but does not interfere with activities of daily living, or affected area (redness, swelling) measures <3 cm; Grade 2 (Moderate): Symptom causes some interference with activities of daily living, or affected area (redness, swelling) measures 3 - 10 cm; Grade 3 (Severe): Symptom prevents activities of daily living or requires treatment, or affected area (redness, swelling) measures > 10 cm. For each reaction, subjects are counted once across all vaccinations at the highest reported level of severity. | Safety Population (subjects who received at least one dose of IMP) | Posted | Number | participants | For 7 days following each vaccination on Days 0, 14, 28 |
|
|
|
| Primary | Incidence of Clinical Laborabory Abnormalities | Incidence of clinical laboratory abnormalities throughout the study (up to Day 84). Clinical laboratory abnormalities are presented as the total of Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (potentially life-threatening) abnormalities according to criteria adapted from the U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research: Guidance for Industry. Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007). Within each laboratory parameter, subjects are counted once for their most severe occurrence of clinical laboratory abnormality. | Safety Population (subjects who received at least one dose of IMP) | Posted | Number | participants | From the time of first immunization on Day 0 to Day 84 |
|
|
|
| Primary | Incidence of Immunologically Significant Adverse Events of Special Interest | Incidence of immunologically significant adverse events of special interest as defined by the Center for Biologics Evaluation and Research from the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination | Safety Population (subjects who received at least one dose of IMP) | Posted | Number | participants | From the time of the first immunization on Day 0 through the 12-month safety follow-up telephone call following the last scheduled vaccination |
|
|
|
| 2 |
| 44 |
| 32 |
| 44 |
| EG001 | AV7909 (Day 0 and 28) | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant | 0 | 34 | 18 | 34 |
| EG002 | AV7909 (Day 0, 14, and 28) | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant | 0 | 23 | 10 | 23 |
| EG003 | AV7909 Reduced Dose | Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28 AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant | 0 | 44 | 27 | 44 |
| EG004 | BioThrax | Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28 BioThrax | 1 | 23 | 9 | 23 |
|
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Rectal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Atelectasis neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment | infant of subject experienced one lung underinflated following delivery by precautionary C-section at 36 weeks because of the subject's bicornuate uterus |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| AST increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood pressure diastolic decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory rate increased | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
Sponsor is responsible for public disclosure of study data. Any proposed publication is subject to review agreed between the Division of Microbiology and Infectious Diseases (DMID) and Emergent; between Emergent and the contract research organizations (CROs)/vendors; and between the CROs and the site Principal Investigator. Data are the property of the sponsor and cannot be published without prior authorization from the sponsor, but data and publication thereof will not be unduly withheld.
| D007239 | Infections |
| Day 28 |
|
| Day 35 |
|
| Day 42 |
|
| Day 49 |
|
| Day 63 |
|
| Day 84 |
|
| Fatigue/Tiredness Grade 2 |
|
| Fatigue/Tiredness Grade 3 |
|
| Muscle Ache Grade 1 |
|
| Muscle Ache Grade 2 |
|
| Muscle Ache Grade 3 |
|
| Headache Grade 1 |
|
| Headache Grade 2 |
|
| Headache Grade 3 |
|
| Fever Grade 1 |
|
| Fever Grade 2 |
|
| Fever Grade 3 |
|
| Warmth Grade 1 |
|
| Warmth Grade 2 |
|
| Warmth Grade 3 |
|
| Tenderness Grade 1 |
|
| Tenderness Grade 2 |
|
| Tenderness Grade 3 |
|
| Itching Grade 1 |
|
| Itching Grade 2 |
|
| Itching Grade 3 |
|
| Pain Grade 1 |
|
| Pain Grade 2 |
|
| Pain Grade 3 |
|
| Arm Motion Limitation Grade 1 |
|
| Arm Motion Limitation Grade 2 |
|
| Arm Motion Limitation Grade 3 |
|
| Redness Grade 1 |
|
| Redness Grade 2 |
|
| Redness Grade 3 |
|
| Lump Grade 1 |
|
| Lump Grade 2 |
|
| Lump Grade 3 |
|
| Swelling Grade 1 |
|
| Swelling Grade 2 |
|
| Swelling Grade 3 |
|
| Bruise Grade 1 |
|
| Bruise Grade 2 |
|
| Bruise Grade 3 |
|
| Leukocytes |
|
| Neutrophils |
|
| Lymphocytes |
|
| Aspartate Aminotransferase |
|
| Alanine Aminotransferase |
|
| Glucose |
|
| Glucose Fasting |
|
| Bilirubin |
|
| Blood Urea Nitrogen |
|
| Urine Glucose |
|
| Urine Protein |
|
| Urine Erythrocytes |
|