Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 years of age).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
80
Intramuscular (IM) vaccination of 1 dose of 0.5 mL
IM vaccination of 1 dose of 0.5 mL
IM vaccination of 1 dose of 0.5 mL
GSK Investigational Site
Berlin, Germany
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs)
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature greater than or equal to (≥) 38 degrees Celsius (°C), as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.
Time frame: Within 30 minutes of vaccination (Min) at Day 1
Number of Subjects With Any Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Time frame: From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination)
Number of Subjects With Any Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.
Time frame: From Day 5 to Day 8
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IM vaccination of 1 dose of 0.5 mL
IM vaccination of 1 dose of 0.5 mL
Number of Subjects With Any Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Time frame: From Day 8 to Day 14
Number of Subjects With Any Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Time frame: From Day 1 to Day 8 (excluding 30 minutes immediately after vaccination)
Number of Subjects With Any Solicited Local and Systemic AEs
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Time frame: From Day 1 to Day 14 (excluding 30 minutes immediately after any vaccination)
Number of Subjects With Any Unsolicited AEs
An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes intercurrent illnesses or injuries and exacerbation of pre-existing conditions. Unsolicited adverse event were defined as symptoms that were not solicited using a Subject Diary and that were spontaneously communicated by a subject who has signed the informed consent. Unsolicited AEs were collected through the Day 29 visit and the analysis was performed for Day 1-29 time frame, instead of Day 1-14 as required by protocol.
Time frame: From Day 1 to Day 29
Number of Subjects With Any Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Study Withdrawal, New Onset of Chronic Disease (NOCDs) and Adverse Events of Special Interest (AESIs).
SAEs are untoward medical occurrences that at any dose resulted in death,was life-threatening,required/prolonged hospitalization,persistent/significant disability/incapacity,congenital anomaly/in important \& significant medical event that could jeopardize the subject/could required intervention to prevent one of the other outcomes mentioned above.MAAEs are AEs that lead to a visit to a healthcare provider.NOCDs are adverse events that represent new diagnosis of a chronic medical condition that was not present/suspected in a subject prior to study enrolment.AESIs were defined according to MedDRA preferred terms.Certain AESIs are monitored after administration of immunostimulatory agents.These are pre-defined \& include AEs in the SOCs of Gastrointestinal disorders,Liver disorders,Metabolic diseases,Musculo-skeletal disorders,Neuroinflammatory disorders,Skin disorders,Vasculitides \& others.
Time frame: From Day 1 to Day 366
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs.
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastrointestinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others
Time frame: From Day 1 to Day 29
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs.
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastroin-testinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others
Time frame: From Day 29 up to study end (Day 366)
Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate.
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in millimoles per liter (mmol/L).
Time frame: At Day 1 (pre-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time frame: At Day 8
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time frame: At Day 29
Absolute Values for Clinical Serum Chemistry Parameters-Creatinine
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: Creatinine (CREA) in micro mole per liter (μmol/L)
Time frame: At Day 1 (pre-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time frame: At Day 8
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time frame: At Day 29
Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: ALT and AST in International Units per liter (IU/L).
Time frame: At Day 1 (pre-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time frame: At Day 8
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time frame: At Day 29
Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: CRP in milligram per liter (mg/L).
Time frame: At Day 1 (pre-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time frame: At Day 8
Changes in Clinical Serum Chemistry Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time frame: At Day 29
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes.
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10\^9 cells per liter (10\^9/L)
Time frame: At Day 1 (pre-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10\^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10\^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time frame: At Day 8
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10\^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time frame: At Day 29
Absolute Values for Hematology Parameters- Red Blood Cells (RBC)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: RBC in 10\^12 cells per liter (10\^12/L).
Time frame: At Day 1 (pre-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: RBC in 10\^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameter: RBC in 10\^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time frame: At Day 8
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameter: RBC in 10\^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time frame: At Day 29
Absolute Values for Hematology Parameters- Hematocrit
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: hematocrit in liter per liter (L/L).
Time frame: At Day 1 (pre-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time frame: At Day 8
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time frame: At Day 29
Absolute Values for Hematology Parameters- Hemoglobin (HGB)
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: HGB in gram per liter (g/L).
Time frame: At Day 1 (pre-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 8 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time frame: At Day 8
Changes in Hematology Parameters
Analysis was performed on blood samples collected at Day 29 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time frame: At Day 29
Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC)
Analysis was performed on urine samples collected at Day 1 (pre-dose) for the following parameter: Urine RBC in microliters (μL).
Time frame: At Day 1 (pre-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 8 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time frame: At Day 8
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 29 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time frame: At Day 29
Absolute Values for Urinalysis Parameters- Urine Glucose
The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L.
Time frame: At Day 1 (pre-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 8 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 (post-dose) results.
Time frame: At Day 8
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at Day 29 (post-dose) for the following parameter: Urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 (post-dose) results.
Time frame: At Day 29
Absolute Values for Urinalysis Parameters- Urine Protein
The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L
Time frame: At Day 1 (pre-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at day 1 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 1 (post-dose) results.
Time frame: At Day 1 (post-dose)
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at day 8 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 8 (post-dose) results.
Time frame: At Day 8
Changes in Urinalysis Parameters
Analysis was performed on urine samples collected at day 29 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 29 (post-dose) results.
Time frame: At Day 29
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Time frame: At Day 1 (post-dose)
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Time frame: At Day 8
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Time frame: At Day 29
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Time frame: At Day 1 (post-dose)
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Time frame: At Day 8
Number of Subjects With Abnormal Laboratory Parameter Values
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Time frame: At Day 29
Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC)
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
Time frame: At Day 1 (pre-dose)
hSBA GMTs Against N. Meningitidis Serogroup C (MenC)
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
Time frame: At Day 29
Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup
GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose).
Time frame: At Day 29
hSBA GMTs Against N. Meningitidis Serogroup C (MenC)
The antibody concentrations were assessed by hSBA directed against MenC and expressed as GMTs.
Time frame: At Day 8 and Day 181
GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup
GMR of GMTs of antibodies against MenC serogroup was evaluated at Day 8 and Day 181 relative to Day 1 (pre-dose).
Time frame: At Day 8 and Day 181
Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC).
The percentage of subjects who achieved hSBA seroresponse against MenC serogroup was evaluated at Day 8, Day 29 and Day 181 after vaccination. Seroresponse was defined as a post vaccination hSBA ≥ 8 for subjects with a baseline hSBA lower than (\<) 4 or had an increase of at least 4 times the baseline hSBA level for subjects with pre vaccination hSBA ≥ 4.
Time frame: At Day 8, Day 29 and Day 181
Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA)
The antibody concentrations were assessed by ELISA and expressed as Geometric Mean Concentrations (GMCs) in microgram per mililiter (μg/mL).
Time frame: At Day 1 (pre-dose), Day 8, Day 29 and Day 181
Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA
The percentage of subjects with at least a 4-fold increase in antibody concentrations to MenC serogroup as measured by ELISA were analysed at day 8, 29 and 181 relative to Day 1 (pre-dose).
Time frame: At Day 8, Day 29 and Day 181