Infections, Meningococcal
Conditions
Brief summary
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).
Interventions
BIOLOGICALInvestigational MenC-CRM adjuavnted with 12.5 ug of LHD153R
Intramuscular (IM) vaccination of 1 dose of 0.5 mL
BIOLOGICALInvestigational MenC-CRM adjuavnted with 25 ug of LHD153R
IM vaccination of 1 dose of 0.5 mL
BIOLOGICALInvestigational MenC-CRM adjuavnted with 50 ug of LHD153R
IM vaccination of 1 dose of 0.5 mL
BIOLOGICALInvestigational MenC-CRM adjuavnted with 100 ug of LHD153R
IM vaccination of 1 dose of 0.5 mL
BIOLOGICALMeningococcal C-CRM Conjugate Vaccine (MenC-CRM)
IM vaccination of 1 dose of 0.5 mL
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female individuals of 18 through 45 years of age on the day of informed consent 2. Healthy volunteers with good physical and mental health status, determined on the basis of the medical history, a physical examination and the results of the screening tests as judged by the investigator 3. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry 4. Individuals who can comply with study procedures including follow-up 5. Individuals that are able to understand, read and write German language 6. Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.
Exclusion criteria
1. Progressive, unstable or uncontrolled clinical conditions 2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study 3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws 4. Abnormal function of the immune system 5. Received immunoglobulins or any blood products within 180 days prior to informed consent 6. Received an investigational or non-registered medicinal product within 30 days prior to informed consent or intend to participate in another clinical study at any time during the conduct of this study 7. Vulnerable subjects (e.g. persons kept in detention), study personnel or an immediate family or household member of study personnel, subjects with legal incapacity or limited legal capacity 8. Any relevant deviation from the laboratory parameters at screening as judged by the investigator 9. Previously received any vaccine that included a MenC antigen 10. Previously suspected or confirmed disease caused by N. meningitides 11. Had household contact with and/or intimate exposure to an individual with culture proven MenC 12. A positive serum or urine pregnancy test prior to the study vaccine administration or are currently lactating. 13. A positive drugs-of-abuse test prior to the study vaccine administration; 14. Received any other vaccines within 30 days prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the administration of study vaccines 15. Any other condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup | At Day 29 | GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose). |
| Absolute Values for Urinalysis Parameters- Urine Glucose | At Day 1 (pre-dose) | The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L. |
| Absolute Values for Urinalysis Parameters- Urine Protein | At Day 1 (pre-dose) | The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L |
| Number of Subjects With Abnormal Laboratory Parameter Values | At Day 1 (post-dose) | 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. |
| Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC) | At Day 1 (pre-dose) | The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs. |
| hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | At Day 29 | The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs. |
| Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Within 30 minutes of vaccination (Min) at Day 1 | 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. |
| Number of Subjects With Any Solicited Local and Systemic AEs | From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination) | 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. |
| Number of Subjects With Any Unsolicited AEs | From Day 1 to Day 29 | 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. |
| 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). | From Day 1 to Day 366 | 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. |
| Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | From Day 1 to Day 29 | 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 |
| Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | At Day 1 (pre-dose) | 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). |
| Changes in Clinical Serum Chemistry Parameters | At Day 1 (post-dose) | 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. |
| Absolute Values for Clinical Serum Chemistry Parameters-Creatinine | At Day 1 (pre-dose) | 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) |
| Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | At Day 1 (pre-dose) | 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). |
| Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP) | At Day 1 (pre-dose) | Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: CRP in milligram per liter (mg/L). |
| Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | At Day 1 (pre-dose) | 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) |
| Changes in Hematology Parameters | At Day 1 (post-dose) | 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. |
| Absolute Values for Hematology Parameters- Red Blood Cells (RBC) | At Day 1 (pre-dose) | 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). |
| Absolute Values for Hematology Parameters- Hematocrit | At Day 1 (pre-dose) | Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: hematocrit in liter per liter (L/L). |
| Absolute Values for Hematology Parameters- Hemoglobin (HGB) | At Day 1 (pre-dose) | Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: HGB in gram per liter (g/L). |
| Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC) | At Day 1 (pre-dose) | Analysis was performed on urine samples collected at Day 1 (pre-dose) for the following parameter: Urine RBC in microliters (μL). |
| Changes in Urinalysis Parameters | At Day 1 (post-dose) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | At Day 8 and Day 181 | GMR of GMTs of antibodies against MenC serogroup was evaluated at Day 8 and Day 181 relative to Day 1 (pre-dose). |
| Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | At Day 8, Day 29 and Day 181 | 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. |
| Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | At Day 1 (pre-dose), Day 8, Day 29 and Day 181 | The antibody concentrations were assessed by ELISA and expressed as Geometric Mean Concentrations (GMCs) in microgram per mililiter (μg/mL). |
| Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | At Day 8, Day 29 and Day 181 | 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). |
| hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | At Day 8 and Day 181 | The antibody concentrations were assessed by hSBA directed against MenC and expressed as GMTs. |
Countries
Germany
Participant flow
Recruitment details
80 subjects were recruited from 1 site in Germany.
Participants by arm
| Arm | Count |
|---|---|
| LHD153R Formulation 1 Group Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 12.5 ug of LHD153R. | 16 |
| LHD153R Formulation 2 Group Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 25 ug of LHD153R. | 16 |
| LHD153R Formulation 3 Group Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 50 ug of LHD153R. | 16 |
| LHD153R Formulation 4 Group Healthy subjects aged 18 to 45 years who received a single dose of investigational Meningococcal C-CRM conjugate vaccine (MenC-CRM) adjuvanted with 100 ug of LHD153R. | 16 |
| MenC Group Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine. | 16 |
| Total | 80 |
Baseline characteristics
| Characteristic | LHD153R Formulation 1 Group | LHD153R Formulation 2 Group | LHD153R Formulation 3 Group | LHD153R Formulation 4 Group | MenC Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 36.8 Years STANDARD_DEVIATION 7.51 | 33.8 Years STANDARD_DEVIATION 6.89 | 34.9 Years STANDARD_DEVIATION 5.18 | 34.4 Years STANDARD_DEVIATION 6.72 | 34.4 Years STANDARD_DEVIATION 7.85 | 34.9 Years STANDARD_DEVIATION 6.79 |
| Race/Ethnicity, Customized Unknown | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 16 Participants | 15 Participants | 16 Participants | 16 Participants | 79 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 5 Participants | 6 Participants | 6 Participants | 24 Participants |
| Sex: Female, Male Male | 13 Participants | 12 Participants | 11 Participants | 10 Participants | 10 Participants | 56 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 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 16 / 16 | 16 / 16 | 16 / 16 | 16 / 16 | 16 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 | 0 / 16 | 0 / 16 | 1 / 16 |
Outcome results
Primary
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)
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT | 26.75 IU/L | Standard Deviation 11.906 |
| LHD153R Formulation 1 Group | Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST | 23.30 IU/L | Standard Deviation 5.88 |
| LHD153R Formulation 2 Group | Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT | 20.17 IU/L | Standard Deviation 9.875 |
| LHD153R Formulation 2 Group | Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST | 25.01 IU/L | Standard Deviation 5.058 |
| LHD153R Formulation 3 Group | Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT | 21.14 IU/L | Standard Deviation 7.92 |
| LHD153R Formulation 3 Group | Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST | 24.11 IU/L | Standard Deviation 4.809 |
| LHD153R Formulation 4 Group | Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST | 23.08 IU/L | Standard Deviation 6.592 |
| LHD153R Formulation 4 Group | Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT | 22.97 IU/L | Standard Deviation 8.747 |
| MenC Group | Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | ALT | 25.86 IU/L | Standard Deviation 12.631 |
| MenC Group | Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) | AST | 24.84 IU/L | Standard Deviation 5.771 |
Primary
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)
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP) | 1.382 mg/L | Standard Deviation 3.353 |
| LHD153R Formulation 2 Group | Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP) | 0.928 mg/L | Standard Deviation 0.663 |
| LHD153R Formulation 3 Group | Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP) | 1.049 mg/L | Standard Deviation 1.003 |
| LHD153R Formulation 4 Group | Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP) | 2.337 mg/L | Standard Deviation 3.718 |
| MenC Group | Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP) | 1.243 mg/L | Standard Deviation 1.34 |
Primary
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)
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Clinical Serum Chemistry Parameters-Creatinine | 77.52 μmol/L | Standard Deviation 12.517 |
| LHD153R Formulation 2 Group | Absolute Values for Clinical Serum Chemistry Parameters-Creatinine | 72.25 μmol/L | Standard Deviation 12.336 |
| LHD153R Formulation 3 Group | Absolute Values for Clinical Serum Chemistry Parameters-Creatinine | 80.43 μmol/L | Standard Deviation 10.086 |
| LHD153R Formulation 4 Group | Absolute Values for Clinical Serum Chemistry Parameters-Creatinine | 74.43 μmol/L | Standard Deviation 13.459 |
| MenC Group | Absolute Values for Clinical Serum Chemistry Parameters-Creatinine | 74.29 μmol/L | Standard Deviation 9.206 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | BUN | 4.545 mmol/L | Standard Deviation 1.085 |
| LHD153R Formulation 1 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Na | 138.07 mmol/L | Standard Deviation 1.226 |
| LHD153R Formulation 1 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Bicarbonate | 25.42 mmol/L | Standard Deviation 1.638 |
| LHD153R Formulation 1 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | K | 4.253 mmol/L | Standard Deviation 0.325 |
| LHD153R Formulation 1 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Cl | 104.25 mmol/L | Standard Deviation 1.382 |
| LHD153R Formulation 2 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | BUN | 5.048 mmol/L | Standard Deviation 1.422 |
| LHD153R Formulation 2 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Cl | 103.94 mmol/L | Standard Deviation 2.057 |
| LHD153R Formulation 2 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | K | 4.176 mmol/L | Standard Deviation 0.162 |
| LHD153R Formulation 2 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Bicarbonate | 25.75 mmol/L | Standard Deviation 1.293 |
| LHD153R Formulation 2 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Na | 136.77 mmol/L | Standard Deviation 1.514 |
| LHD153R Formulation 3 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Cl | 103.91 mmol/L | Standard Deviation 1.973 |
| LHD153R Formulation 3 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Na | 136.73 mmol/L | Standard Deviation 1.891 |
| LHD153R Formulation 3 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | K | 4.185 mmol/L | Standard Deviation 0.346 |
| LHD153R Formulation 3 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | BUN | 5.247 mmol/L | Standard Deviation 1.039 |
| LHD153R Formulation 3 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Bicarbonate | 27.09 mmol/L | Standard Deviation 2.18 |
| LHD153R Formulation 4 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Bicarbonate | 26.64 mmol/L | Standard Deviation 1.944 |
| LHD153R Formulation 4 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Na | 138.29 mmol/L | Standard Deviation 1.875 |
| LHD153R Formulation 4 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | BUN | 4.616 mmol/L | Standard Deviation 0.93 |
| LHD153R Formulation 4 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Cl | 104.99 mmol/L | Standard Deviation 2.168 |
| LHD153R Formulation 4 Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | K | 3.962 mmol/L | Standard Deviation 0.178 |
| MenC Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Cl | 104.03 mmol/L | Standard Deviation 2.12 |
| MenC Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | BUN | 4.606 mmol/L | Standard Deviation 1.327 |
| MenC Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Na | 137.06 mmol/L | Standard Deviation 1.821 |
| MenC Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | Bicarbonate | 25.98 mmol/L | Standard Deviation 1.749 |
| MenC Group | Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. | K | 4.253 mmol/L | Standard Deviation 0.253 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Basophil | 0.033 10^9/L | Standard Deviation 0.015 |
| LHD153R Formulation 1 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Platelets | 203.9 10^9/L | Standard Deviation 37.9 |
| LHD153R Formulation 1 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Neutrophils | 3.811 10^9/L | Standard Deviation 1.865 |
| LHD153R Formulation 1 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Leukocytes | 6.150 10^9/L | Standard Deviation 2.116 |
| LHD153R Formulation 1 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Eosinophils | 0.128 10^9/L | Standard Deviation 0.065 |
| LHD153R Formulation 1 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Lymphocytes | 1.653 10^9/L | Standard Deviation 0.453 |
| LHD153R Formulation 1 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Monocytes | 0.413 10^9/L | Standard Deviation 0.11 |
| LHD153R Formulation 2 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Monocytes | 0.365 10^9/L | Standard Deviation 0.108 |
| LHD153R Formulation 2 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Lymphocytes | 1.764 10^9/L | Standard Deviation 0.425 |
| LHD153R Formulation 2 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Eosinophils | 0.183 10^9/L | Standard Deviation 0.127 |
| LHD153R Formulation 2 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Basophil | 0.034 10^9/L | Standard Deviation 0.02 |
| LHD153R Formulation 2 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Neutrophils | 2.833 10^9/L | Standard Deviation 0.712 |
| LHD153R Formulation 2 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Leukocytes | 5.278 10^9/L | Standard Deviation 1.17 |
| LHD153R Formulation 2 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Platelets | 208.3 10^9/L | Standard Deviation 38.82 |
| LHD153R Formulation 3 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Lymphocytes | 0.425 10^9/L | Standard Deviation 0.562 |
| LHD153R Formulation 3 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Basophil | 0.033 10^9/L | Standard Deviation 0.014 |
| LHD153R Formulation 3 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Eosinophils | 0.184 10^9/L | Standard Deviation 0.114 |
| LHD153R Formulation 3 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Leukocytes | 6.085 10^9/L | Standard Deviation 1.72 |
| LHD153R Formulation 3 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Monocytes | 0.428 10^9/L | Standard Deviation 0.114 |
| LHD153R Formulation 3 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Neutrophils | 3.502 10^9/L | Standard Deviation 1.157 |
| LHD153R Formulation 3 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Platelets | 239.9 10^9/L | Standard Deviation 60.28 |
| LHD153R Formulation 4 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Leukocytes | 6.031 10^9/L | Standard Deviation 1.56 |
| LHD153R Formulation 4 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Monocytes | 0.398 10^9/L | Standard Deviation 0.09 |
| LHD153R Formulation 4 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Eosinophils | 0.150 10^9/L | Standard Deviation 0.105 |
| LHD153R Formulation 4 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Platelets | 197.8 10^9/L | Standard Deviation 45.04 |
| LHD153R Formulation 4 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Neutrophils | 3.618 10^9/L | Standard Deviation 1.372 |
| LHD153R Formulation 4 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Basophil | 0.030 10^9/L | Standard Deviation 0.014 |
| LHD153R Formulation 4 Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Lymphocytes | 1.751 10^9/L | Standard Deviation 0.332 |
| MenC Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Leukocytes | 6.383 10^9/L | Standard Deviation 1.347 |
| MenC Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Platelets | 224.0 10^9/L | Standard Deviation 50.46 |
| MenC Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Neutrophils | 3.692 10^9/L | Standard Deviation 1.095 |
| MenC Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Monocytes | 0.451 10^9/L | Standard Deviation 0.115 |
| MenC Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Eosinophils | 0.234 10^9/L | Standard Deviation 0.136 |
| MenC Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Basophil | 0.029 10^9/L | Standard Deviation 0.012 |
| MenC Group | Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. | Lymphocytes | 1.868 10^9/L | Standard Deviation 0.413 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Hematology Parameters- Hematocrit | 0.428 L/L | Standard Deviation 0.026 |
| LHD153R Formulation 2 Group | Absolute Values for Hematology Parameters- Hematocrit | 0.415 L/L | Standard Deviation 0.032 |
| LHD153R Formulation 3 Group | Absolute Values for Hematology Parameters- Hematocrit | 0.409 L/L | Standard Deviation 0.029 |
| LHD153R Formulation 4 Group | Absolute Values for Hematology Parameters- Hematocrit | 0.411 L/L | Standard Deviation 0.033 |
| MenC Group | Absolute Values for Hematology Parameters- Hematocrit | 0.424 L/L | Standard Deviation 0.029 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Hematology Parameters- Hemoglobin (HGB) | 144.3 g/L | Standard Deviation 8.5 |
| LHD153R Formulation 2 Group | Absolute Values for Hematology Parameters- Hemoglobin (HGB) | 139.2 g/L | Standard Deviation 11.35 |
| LHD153R Formulation 3 Group | Absolute Values for Hematology Parameters- Hemoglobin (HGB) | 137.1 g/L | Standard Deviation 11.47 |
| LHD153R Formulation 4 Group | Absolute Values for Hematology Parameters- Hemoglobin (HGB) | 139.3 g/L | Standard Deviation 13.15 |
| MenC Group | Absolute Values for Hematology Parameters- Hemoglobin (HGB) | 143.5 g/L | Standard Deviation 10.85 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Hematology Parameters- Red Blood Cells (RBC) | 4.777 10^12/L | Standard Deviation 0.358 |
| LHD153R Formulation 2 Group | Absolute Values for Hematology Parameters- Red Blood Cells (RBC) | 4.598 10^12/L | Standard Deviation 0.377 |
| LHD153R Formulation 3 Group | Absolute Values for Hematology Parameters- Red Blood Cells (RBC) | 4.724 10^12/L | Standard Deviation 0.492 |
| LHD153R Formulation 4 Group | Absolute Values for Hematology Parameters- Red Blood Cells (RBC) | 4.676 10^12/L | Standard Deviation 0.362 |
| MenC Group | Absolute Values for Hematology Parameters- Red Blood Cells (RBC) | 4.773 10^12/L | Standard Deviation 0.315 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC) | 2.8 μL | Standard Deviation 6.82 |
| LHD153R Formulation 2 Group | Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC) | 1.3 μL | Standard Deviation 3.42 |
| LHD153R Formulation 3 Group | Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC) | 7.2 μL | Standard Deviation 13.41 |
| LHD153R Formulation 4 Group | Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC) | 20.0 μL | Standard Deviation 20 |
| MenC Group | Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC) | 6.9 μL | Standard Deviation 17.02 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Urinalysis Parameters- Urine Glucose | 0.0 mmol/L | Standard Deviation 0 |
| LHD153R Formulation 2 Group | Absolute Values for Urinalysis Parameters- Urine Glucose | 0.0 mmol/L | Standard Deviation 0 |
| LHD153R Formulation 3 Group | Absolute Values for Urinalysis Parameters- Urine Glucose | 0.0 mmol/L | Standard Deviation 0 |
| LHD153R Formulation 4 Group | Absolute Values for Urinalysis Parameters- Urine Glucose | 0.0 mmol/L | Standard Deviation 0 |
| MenC Group | Absolute Values for Urinalysis Parameters- Urine Glucose | 0.0 mmol/L | Standard Deviation 0 |
Primary
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)
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Absolute Values for Urinalysis Parameters- Urine Protein | 0.000 g/L | Standard Deviation 0 |
| LHD153R Formulation 2 Group | Absolute Values for Urinalysis Parameters- Urine Protein | 0.000 g/L | Standard Deviation 0 |
| LHD153R Formulation 3 Group | Absolute Values for Urinalysis Parameters- Urine Protein | 0.000 g/L | Standard Deviation 0 |
| LHD153R Formulation 4 Group | Absolute Values for Urinalysis Parameters- Urine Protein | 0.000 g/L | Standard Deviation 0 |
| MenC Group | Absolute Values for Urinalysis Parameters- Urine Protein | 0.000 g/L | Standard Deviation 0 |
Primary
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
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | ALT | -2.15 Difference of IU/L | Standard Deviation 9.553 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | AST | 0.56 Difference of IU/L | Standard Deviation 6.031 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | ALT | 2.36 Difference of IU/L | Standard Deviation 6.04 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | AST | 1.88 Difference of IU/L | Standard Deviation 16.06 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | ALT | 5.99 Difference of IU/L | Standard Deviation 10.114 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | AST | 2.24 Difference of IU/L | Standard Deviation 5.948 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | AST | -0.74 Difference of IU/L | Standard Deviation 6.674 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | ALT | 0.91 Difference of IU/L | Standard Deviation 7.192 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | ALT | 3.78 Difference of IU/L | Standard Deviation 8.382 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | AST | 2.61 Difference of IU/L | Standard Deviation 6.823 |
Primary
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)
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | BUN | -0.209 Difference of mmol/L | Standard Deviation 0.944 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | Na | -0.34 Difference of mmol/L | Standard Deviation 1.051 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 0.09 Difference of mmol/L | Standard Deviation 1.08 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | K | 0.002 Difference of mmol/L | Standard Deviation 0.361 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -0.55 Difference of mmol/L | Standard Deviation 1.526 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | BUN | -0.911 Difference of mmol/L | Standard Deviation 0.838 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -0.32 Difference of mmol/L | Standard Deviation 2.005 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | K | 0.043 Difference of mmol/L | Standard Deviation 0.205 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 0.51 Difference of mmol/L | Standard Deviation 1.381 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | Na | 0.45 Difference of mmol/L | Standard Deviation 1.693 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -0.74 Difference of mmol/L | Standard Deviation 2.08 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | Na | -0.33 Difference of mmol/L | Standard Deviation 2.097 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | K | 0.100 Difference of mmol/L | Standard Deviation 0.31 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | BUN | -0.949 Difference of mmol/L | Standard Deviation 0.94 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 0.88 Difference of mmol/L | Standard Deviation 1.69 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 0.41 Difference of mmol/L | Standard Deviation 1.413 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | Na | -0.86 Difference of mmol/L | Standard Deviation 1.744 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | BUN | -0.556 Difference of mmol/L | Standard Deviation 0.493 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -1.06 Difference of mmol/L | Standard Deviation 2.828 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | K | 0.028 Difference of mmol/L | Standard Deviation 0.208 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | Cl | -0.10 Difference of mmol/L | Standard Deviation 2.122 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | BUN | -0.433 Difference of mmol/L | Standard Deviation 0.616 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | Na | -0.09 Difference of mmol/L | Standard Deviation 2.02 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 0.66 Difference of mmol/L | Standard Deviation 1.733 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | K | 0.178 Difference of mmol/L | Standard Deviation 0.254 |
Primary
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
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | -0.202 Difference of mg/L | Standard Deviation 3.195 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | 0.348 Difference of mg/L | Standard Deviation 0.849 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | 0.200 Difference of mg/L | Standard Deviation 0.535 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | 1.075 Difference of mg/L | Standard Deviation 8.004 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | -0.058 Difference of mg/L | Standard Deviation 0.948 |
Primary
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
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | -0.393 Difference of mg/L | Standard Deviation 3.26 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | 0.339 Difference of mg/L | Standard Deviation 0.878 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | -0.057 Difference of mg/L | Standard Deviation 0.83 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | 7.736 Difference of mg/L | Standard Deviation 30.996 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | 0.153 Difference of mg/L | Standard Deviation 0.934 |
Primary
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)
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | -0.148 Difference of mg/L | Standard Deviation 1.334 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | 0.888 Difference of mg/L | Standard Deviation 2.177 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | 0.439 Difference of mg/L | Standard Deviation 1.015 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | 1.646 Difference of mg/L | Standard Deviation 4.231 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | 0.239 Difference of mg/L | Standard Deviation 0.777 |
Primary
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
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | BUN | 0.125 Difference of mmol/L | Standard Deviation 1.177 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | Na | -0.39 Difference of mmol/L | Standard Deviation 2.129 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 1.20 Difference of mmol/L | Standard Deviation 1.747 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | K | -0.030 Difference of mmol/L | Standard Deviation 0.302 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -1.37 Difference of mmol/L | Standard Deviation 1.74 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | BUN | -0.507 Difference of mmol/L | Standard Deviation 0.758 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -0.28 Difference of mmol/L | Standard Deviation 2.467 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | K | 0.233 Difference of mmol/L | Standard Deviation 0.274 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 1.00 Difference of mmol/L | Standard Deviation 1.485 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | Na | 0.08 Difference of mmol/L | Standard Deviation 2.066 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | Cl | 0.27 Difference of mmol/L | Standard Deviation 2.265 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | Na | 0.68 Difference of mmol/L | Standard Deviation 1.951 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | K | 0.143 Difference of mmol/L | Standard Deviation 0.322 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | BUN | -0.128 Difference of mmol/L | Standard Deviation 1.236 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 0.14 Difference of mmol/L | Standard Deviation 1.614 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 0.82 Difference of mmol/L | Standard Deviation 1.633 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | Na | -0.61 Difference of mmol/L | Standard Deviation 2.305 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | BUN | 0.144 Difference of mmol/L | Standard Deviation 1.144 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -1.73 Difference of mmol/L | Standard Deviation 4.39 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | K | 0.128 Difference of mmol/L | Standard Deviation 0.137 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | Cl | -1.30 Difference of mmol/L | Standard Deviation 2.642 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | BUN | 0.003 Difference of mmol/L | Standard Deviation 0.909 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | Na | 0.11 Difference of mmol/L | Standard Deviation 1.676 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 0.41 Difference of mmol/L | Standard Deviation 2.117 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | K | 0.071 Difference of mmol/L | Standard Deviation 0.208 |
Primary
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
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | BUN | 0.500 Difference of mmol/L | Standard Deviation 1.199 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | Na | 0.06 Difference of mmol/L | Standard Deviation 1.834 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 0.64 Difference of mmol/L | Standard Deviation 1.672 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | K | -0.008 Difference of mmol/L | Standard Deviation 0.426 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -1.02 Difference of mmol/L | Standard Deviation 2.144 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | BUN | -0.103 Difference of mmol/L | Standard Deviation 1.18 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -0.34 Difference of mmol/L | Standard Deviation 2.379 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | K | 0.290 Difference of mmol/L | Standard Deviation 0.369 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 2.66 Difference of mmol/L | Standard Deviation 1.787 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | Na | 1.11 Difference of mmol/L | Standard Deviation 1.993 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -1.38 Difference of mmol/L | Standard Deviation 1.438 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | Na | 1.66 Difference of mmol/L | Standard Deviation 2.317 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | K | 0.147 Difference of mmol/L | Standard Deviation 0.377 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | BUN | 0.021 Difference of mmol/L | Standard Deviation 1.214 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 2.01 Difference of mmol/L | Standard Deviation 2.158 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 0.52 Difference of mmol/L | Standard Deviation 2.03 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | Na | 0.09 Difference of mmol/L | Standard Deviation 1.88 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | BUN | 0.476 Difference of mmol/L | Standard Deviation 0.784 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | Cl | -1.21 Difference of mmol/L | Standard Deviation 1.87 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | K | 0.204 Difference of mmol/L | Standard Deviation 0.255 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | Cl | -1.03 Difference of mmol/L | Standard Deviation 1.862 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | BUN | 0.216 Difference of mmol/L | Standard Deviation 1.023 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | Na | 0.76 Difference of mmol/L | Standard Deviation 1.926 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | Bicarbonate | 1.27 Difference of mmol/L | Standard Deviation 2.34 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | K | 0.109 Difference of mmol/L | Standard Deviation 0.299 |
Primary
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)
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | 0.64 Difference of μmol/L | Standard Deviation 3.393 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | 2.59 Difference of μmol/L | Standard Deviation 2.622 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | 0.21 Difference of μmol/L | Standard Deviation 7.479 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | -0.50 Difference of μmol/L | Standard Deviation 4.654 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | 1.41 Difference of μmol/L | Standard Deviation 4.663 |
Primary
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
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | 3.61 Difference of μmol/L | Standard Deviation 5.109 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | 3.48 Difference of μmol/L | Standard Deviation 5.377 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | 2.49 Difference of μmol/L | Standard Deviation 4.936 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | 2.03 Difference of μmol/L | Standard Deviation 5.052 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | 2.40 Difference of μmol/L | Standard Deviation 3.44 |
Primary
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
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | 4.51 Difference of μmol/L | Standard Deviation 4.557 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | 5.68 Difference of μmol/L | Standard Deviation 5.878 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | 3.09 Difference of μmol/L | Standard Deviation 6.345 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | 1.72 Difference of μmol/L | Standard Deviation 4.906 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | 3.24 Difference of μmol/L | Standard Deviation 6.355 |
Primary
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)
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | ALT | -2.29 Difference of IU/L | Standard Deviation 3.044 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | AST | -2.41 Difference of IU/L | Standard Deviation 2.461 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | ALT | -1.28 Difference of IU/L | Standard Deviation 1.563 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | AST | -2.82 Difference of IU/L | Standard Deviation 2.451 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | ALT | -1.40 Difference of IU/L | Standard Deviation 2.892 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | AST | -3.07 Difference of IU/L | Standard Deviation 3.28 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | AST | -1.98 Difference of IU/L | Standard Deviation 3.391 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | ALT | -1.19 Difference of IU/L | Standard Deviation 3.969 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | ALT | 0.23 Difference of IU/L | Standard Deviation 2.569 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | AST | -1.44 Difference of IU/L | Standard Deviation 2.59 |
Primary
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
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | ALT | 0.70 Difference of IU/L | Standard Deviation 5.806 |
| LHD153R Formulation 1 Group | Changes in Clinical Serum Chemistry Parameters | AST | 2.58 Difference of IU/L | Standard Deviation 4.93 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | ALT | 2.08 Difference of IU/L | Standard Deviation 5.027 |
| LHD153R Formulation 2 Group | Changes in Clinical Serum Chemistry Parameters | AST | 2.47 Difference of IU/L | Standard Deviation 13.382 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | ALT | 0.47 Difference of IU/L | Standard Deviation 4.58 |
| LHD153R Formulation 3 Group | Changes in Clinical Serum Chemistry Parameters | AST | 0.21 Difference of IU/L | Standard Deviation 6.431 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | AST | 0.43 Difference of IU/L | Standard Deviation 6.743 |
| LHD153R Formulation 4 Group | Changes in Clinical Serum Chemistry Parameters | ALT | 1.03 Difference of IU/L | Standard Deviation 6.764 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | ALT | 1.88 Difference of IU/L | Standard Deviation 4.15 |
| MenC Group | Changes in Clinical Serum Chemistry Parameters | AST | 0.00 Difference of IU/L | Standard Deviation 4.103 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | 1.2 Difference of g/L | Standard Deviation 5.33 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | 5.4 Difference of g/L | Standard Deviation 5.55 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | 5.4 Difference of g/L | Standard Deviation 5.25 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | 3.1 Difference of g/L | Standard Deviation 4.22 |
| MenC Group | Changes in Hematology Parameters | 1.6 Difference of g/L | Standard Deviation 5.03 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Basophils | 0.000 Difference of 10^9/L | Standard Deviation 0.014 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Platelets | -2.5 Difference of 10^9/L | Standard Deviation 11.08 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Neutrophils | 0.686 Difference of 10^9/L | Standard Deviation 1.436 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Leukocytes | 0.853 Difference of 10^9/L | Standard Deviation 1.442 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Eosinophils | 0.015 Difference of 10^9/L | Standard Deviation 0.045 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Lymphocytes | 0.077 Difference of 10^9/L | Standard Deviation 0.314 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Monocytes | 0.075 Difference of 10^9/L | Standard Deviation 0.068 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Monocytes | 0.053 Difference of 10^9/L | Standard Deviation 0.102 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Lymphocytes | -0.147 Difference of 10^9/L | Standard Deviation 0.533 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Eosinophils | -0.018 Difference of 10^9/L | Standard Deviation 0.057 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Basophils | 0.000 Difference of 10^9/L | Standard Deviation 0.009 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Neutrophils | 1.044 Difference of 10^9/L | Standard Deviation 0.945 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Leukocytes | 0.923 Difference of 10^9/L | Standard Deviation 1.291 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Platelets | -0.6 Difference of 10^9/L | Standard Deviation 15.19 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Lymphocytes | -0.302 Difference of 10^9/L | Standard Deviation 0.358 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Basophils | -0.003 Difference of 10^9/L | Standard Deviation 0.009 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Eosinophils | -0.009 Difference of 10^9/L | Standard Deviation 0.041 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Leukocytes | 0.584 Difference of 10^9/L | Standard Deviation 1.048 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Monocytes | 0.049 Difference of 10^9/L | Standard Deviation 0.084 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Neutrophils | 0.863 Difference of 10^9/L | Standard Deviation 0.851 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Platelets | -0.1 Difference of 10^9/L | Standard Deviation 12.75 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Leukocytes | 0.294 Difference of 10^9/L | Standard Deviation 1.531 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Monocytes | 0.051 Difference of 10^9/L | Standard Deviation 0.102 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Eosinophils | -0.016 Difference of 10^9/L | Standard Deviation 0.05 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Platelets | -2.3 Difference of 10^9/L | Standard Deviation 9.74 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Neutrophils | 0.451 Difference of 10^9/L | Standard Deviation 1.182 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Basophils | 0.004 Difference of 10^9/L | Standard Deviation 0.014 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Lymphocytes | -0.197 Difference of 10^9/L | Standard Deviation 0.397 |
| MenC Group | Changes in Hematology Parameters | Leukocytes | 0.621 Difference of 10^9/L | Standard Deviation 0.968 |
| MenC Group | Changes in Hematology Parameters | Platelets | -0.8 Difference of 10^9/L | Standard Deviation 14.2 |
| MenC Group | Changes in Hematology Parameters | Neutrophils | 0.558 Difference of 10^9/L | Standard Deviation 0.873 |
| MenC Group | Changes in Hematology Parameters | Monocytes | 0.040 Difference of 10^9/L | Standard Deviation 0.078 |
| MenC Group | Changes in Hematology Parameters | Eosinophils | 0.016 Difference of 10^9/L | Standard Deviation 0.052 |
| MenC Group | Changes in Hematology Parameters | Basophils | 0.001 Difference of 10^9/L | Standard Deviation 0.011 |
| MenC Group | Changes in Hematology Parameters | Lymphocytes | 0.000 Difference of 10^9/L | Standard Deviation 0.246 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Basophils | -0.001 Difference of 10^9/L | Standard Deviation 0.016 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Platelets | 28.2 Difference of 10^9/L | Standard Deviation 27.77 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Neutrophils | -0.256 Difference of 10^9/L | Standard Deviation 1.567 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Leukocytes | 0.123 Difference of 10^9/L | Standard Deviation 1.624 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Eosinophils | 0.044 Difference of 10^9/L | Standard Deviation 0.048 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Lymphocytes | 0.333 Difference of 10^9/L | Standard Deviation 0.416 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Monocytes | 0.004 Difference of 10^9/L | Standard Deviation 0.086 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Monocytes | -0.001 Difference of 10^9/L | Standard Deviation 0.069 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Lymphocytes | 0.029 Difference of 10^9/L | Standard Deviation 0.404 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Eosinophils | -0.006 Difference of 10^9/L | Standard Deviation 0.059 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Basophils | 0.004 Difference of 10^9/L | Standard Deviation 0.01 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Neutrophils | 0.048 Difference of 10^9/L | Standard Deviation 0.64 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Leukocytes | 0.086 Difference of 10^9/L | Standard Deviation 0.968 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Platelets | 25.3 Difference of 10^9/L | Standard Deviation 16.19 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Lymphocytes | -0.007 Difference of 10^9/L | Standard Deviation 0.476 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Basophils | -0.002 Difference of 10^9/L | Standard Deviation 0.014 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Eosinophils | -0.013 Difference of 10^9/L | Standard Deviation 0.058 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Leukocytes | -0.417 Difference of 10^9/L | Standard Deviation 1.161 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Monocytes | -0.053 Difference of 10^9/L | Standard Deviation 0.087 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Neutrophils | -0.342 Difference of 10^9/L | Standard Deviation 0.854 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Platelets | 13.1 Difference of 10^9/L | Standard Deviation 28.34 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Leukocytes | -0.451 Difference of 10^9/L | Standard Deviation 1.245 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Monocytes | -0.016 Difference of 10^9/L | Standard Deviation 0.097 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Eosinophils | 0.025 Difference of 10^9/L | Standard Deviation 0.064 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Platelets | 17.9 Difference of 10^9/L | Standard Deviation 16.39 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Neutrophils | -0.603 Difference of 10^9/L | Standard Deviation 1.184 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Basophils | 0.006 Difference of 10^9/L | Standard Deviation 0.013 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Lymphocytes | 0.115 Difference of 10^9/L | Standard Deviation 0.349 |
| MenC Group | Changes in Hematology Parameters | Leukocytes | 0.074 Difference of 10^9/L | Standard Deviation 0.978 |
| MenC Group | Changes in Hematology Parameters | Platelets | 22.4 Difference of 10^9/L | Standard Deviation 22.9 |
| MenC Group | Changes in Hematology Parameters | Neutrophils | -0.031 Difference of 10^9/L | Standard Deviation 1.015 |
| MenC Group | Changes in Hematology Parameters | Monocytes | 0.027 Difference of 10^9/L | Standard Deviation 0.081 |
| MenC Group | Changes in Hematology Parameters | Eosinophils | 0.033 Difference of 10^9/L | Standard Deviation 0.074 |
| MenC Group | Changes in Hematology Parameters | Basophils | 0.006 Difference of 10^9/L | Standard Deviation 0.016 |
| MenC Group | Changes in Hematology Parameters | Lymphocytes | 0.025 Difference of 10^9/L | Standard Deviation 0.339 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Basophils | 0.007 Difference of 10^9/L | Standard Deviation 0.012 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Platelets | 19.6 Difference of 10^9/L | Standard Deviation 33.37 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Neutrophiles | -0.276 Difference of 10^9/L | Standard Deviation 1.431 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Leukocytes | 0.136 Difference of 10^9/L | Standard Deviation 1.637 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Eosinophils | 0.039 Difference of 10^9/L | Standard Deviation 0.063 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Lymphocytes | 0.294 Difference of 10^9/L | Standard Deviation 0.506 |
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | Monocytes | 0.079 Difference of 10^9/L | Standard Deviation 0.109 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Monocytes | 0.025 Difference of 10^9/L | Standard Deviation 0.09 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Lymphocytes | 0.038 Difference of 10^9/L | Standard Deviation 0.476 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Eosinophils | -0.014 Difference of 10^9/L | Standard Deviation 0.107 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Basophils | 0.002 Difference of 10^9/L | Standard Deviation 0.01 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Neutrophiles | 0.277 Difference of 10^9/L | Standard Deviation 0.611 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Leukocytes | 0.328 Difference of 10^9/L | Standard Deviation 0.781 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | Platelets | 24.5 Difference of 10^9/L | Standard Deviation 15.3 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Lymphocytes | -0.041 Difference of 10^9/L | Standard Deviation 0.451 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Basophils | 0.003 Difference of 10^9/L | Standard Deviation 0.011 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Eosinophils | 0.027 Difference of 10^9/L | Standard Deviation 0.078 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Leukocytes | -0.023 Difference of 10^9/L | Standard Deviation 1.442 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Monocytes | -0.002 Difference of 10^9/L | Standard Deviation 0.098 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Neutrophiles | -0.016 Difference of 10^9/L | Standard Deviation 0.97 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | Platelets | 6.6 Difference of 10^9/L | Standard Deviation 15.68 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Leukocytes | -0.212 Difference of 10^9/L | Standard Deviation 1.264 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Monocytes | -0.028 Difference of 10^9/L | Standard Deviation 0.099 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Eosinophils | 0.020 Difference of 10^9/L | Standard Deviation 0.052 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Platelets | 10.1 Difference of 10^9/L | Standard Deviation 16.55 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Neutrophiles | -0.355 Difference of 10^9/L | Standard Deviation 1.228 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Basophils | 0.006 Difference of 10^9/L | Standard Deviation 0.012 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | Lymphocytes | 0.122 Difference of 10^9/L | Standard Deviation 0.429 |
| MenC Group | Changes in Hematology Parameters | Leukocytes | -0.086 Difference of 10^9/L | Standard Deviation 1.161 |
| MenC Group | Changes in Hematology Parameters | Platelets | 11.1 Difference of 10^9/L | Standard Deviation 22.47 |
| MenC Group | Changes in Hematology Parameters | Neutrophiles | -0.234 Difference of 10^9/L | Standard Deviation 1.091 |
| MenC Group | Changes in Hematology Parameters | Monocytes | 0.019 Difference of 10^9/L | Standard Deviation 0.092 |
| MenC Group | Changes in Hematology Parameters | Eosinophils | 0.018 Difference of 10^9/L | Standard Deviation 0.063 |
| MenC Group | Changes in Hematology Parameters | Basophils | 0.004 Difference of 10^9/L | Standard Deviation 0.013 |
| MenC Group | Changes in Hematology Parameters | Lymphocytes | 0.105 Difference of 10^9/L | Standard Deviation 0.268 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | 0.024 Difference of 10^12/L | Standard Deviation 0.146 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | 0.064 Difference of 10^12/L | Standard Deviation 0.198 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | 0.139 Difference of 10^12/L | Standard Deviation 0.167 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | 0.019 Difference of 10^12/L | Standard Deviation 0.205 |
| MenC Group | Changes in Hematology Parameters | 0.069 Difference of 10^12/L | Standard Deviation 0.174 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | 0.058 Difference of 10^12/L | Standard Deviation 0.171 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | 0.102 Difference of 10^12/L | Standard Deviation 0.256 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | 0.014 Difference of 10^12/L | Standard Deviation 0.216 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | 0.008 Difference of 10^12/L | Standard Deviation 0.144 |
| MenC Group | Changes in Hematology Parameters | 0.061 Difference of 10^12/L | Standard Deviation 0.211 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | 0.094 Difference of 10^12/L | Standard Deviation 0.239 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | 0.209 Difference of 10^12/L | Standard Deviation 0.187 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | 0.197 Difference of 10^12/L | Standard Deviation 0.208 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | -0.001 Difference of 10^12/L | Standard Deviation 0.2 |
| MenC Group | Changes in Hematology Parameters | 0.052 Difference of 10^12/L | Standard Deviation 0.199 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | 0.002 Difference of L/L | Standard Deviation 0.013 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | 0.002 Difference of L/L | Standard Deviation 0.017 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | 0.013 Difference of L/L | Standard Deviation 0.017 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | -0.001 Difference of L/L | Standard Deviation 0.019 |
| MenC Group | Changes in Hematology Parameters | 0.006 Difference of L/L | Standard Deviation 0.018 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | 0.006 Difference of L/L | Standard Deviation 0.015 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | 0.010 Difference of L/L | Standard Deviation 0.022 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | 0.002 Difference of L/L | Standard Deviation 0.018 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | -0.001 Difference of L/L | Standard Deviation 0.011 |
| MenC Group | Changes in Hematology Parameters | 0.005 Difference of L/L | Standard Deviation 0.019 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | 0.008 Difference of L/L | Standard Deviation 0.023 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | 0.021 Difference of L/L | Standard Deviation 0.017 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | 0.021 Difference of L/L | Standard Deviation 0.019 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | 0.001 Difference of L/L | Standard Deviation 0.016 |
| MenC Group | Changes in Hematology Parameters | 0.007 Difference of L/L | Standard Deviation 0.016 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | 1.6 Difference of g/L | Standard Deviation 3.67 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | 2.3 Difference of g/L | Standard Deviation 5.43 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | 4.6 Difference of g/L | Standard Deviation 4.18 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | 0.6 Difference of g/L | Standard Deviation 5.7 |
| MenC Group | Changes in Hematology Parameters | 2.3 Difference of g/L | Standard Deviation 4.51 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Hematology Parameters | 1.5 Difference of g/L | Standard Deviation 5.07 |
| LHD153R Formulation 2 Group | Changes in Hematology Parameters | 3.8 Difference of g/L | Standard Deviation 7.04 |
| LHD153R Formulation 3 Group | Changes in Hematology Parameters | 1.4 Difference of g/L | Standard Deviation 6.15 |
| LHD153R Formulation 4 Group | Changes in Hematology Parameters | 2.8 Difference of g/L | Standard Deviation 4.02 |
| MenC Group | Changes in Hematology Parameters | 2.8 Difference of g/L | Standard Deviation 4.99 |
Primary
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)
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Urinalysis Parameters | 0 Difference of mmol/L | Standard Deviation 0 |
| LHD153R Formulation 2 Group | Changes in Urinalysis Parameters | 0 Difference of mmol/L | Standard Deviation 0 |
| LHD153R Formulation 3 Group | Changes in Urinalysis Parameters | 0 Difference of mmol/L | Standard Deviation 0 |
| LHD153R Formulation 4 Group | Changes in Urinalysis Parameters | 0 Difference of mmol/L | Standard Deviation 0 |
| MenC Group | Changes in Urinalysis Parameters | 0 Difference of mmol/L | Standard Deviation 0 |
Primary
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
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Urinalysis Parameters | 0.0 Difference of mmol/L | Standard Deviation 0 |
| LHD153R Formulation 2 Group | Changes in Urinalysis Parameters | 0.0 Difference of mmol/L | Standard Deviation 0 |
| LHD153R Formulation 3 Group | Changes in Urinalysis Parameters | 0.0 Difference of mmol/L | Standard Deviation 0 |
| LHD153R Formulation 4 Group | Changes in Urinalysis Parameters | 0.0 Difference of mmol/L | Standard Deviation 0 |
| MenC Group | Changes in Urinalysis Parameters | 0.0 Difference of mmol/L | Standard Deviation 0 |
Primary
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
Population: Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had either post-vaccination AE or reactogenicity records.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Urinalysis Parameters | 0.0 Difference of mmol/L | Standard Deviation 0 |
| LHD153R Formulation 2 Group | Changes in Urinalysis Parameters | 0.0 Difference of mmol/L | Standard Deviation 0 |
| LHD153R Formulation 3 Group | Changes in Urinalysis Parameters | 0.0 Difference of mmol/L | Standard Deviation 0 |
| LHD153R Formulation 4 Group | Changes in Urinalysis Parameters | 0.0 Difference of mmol/L | Standard Deviation 0 |
| MenC Group | Changes in Urinalysis Parameters | 0.0 Difference of mmol/L | Standard Deviation 0 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Urinalysis Parameters | 0 Difference of g/L | Standard Deviation 0 |
| LHD153R Formulation 2 Group | Changes in Urinalysis Parameters | 0 Difference of g/L | Standard Deviation 0 |
| LHD153R Formulation 3 Group | Changes in Urinalysis Parameters | 0 Difference of g/L | Standard Deviation 0 |
| LHD153R Formulation 4 Group | Changes in Urinalysis Parameters | 0 Difference of g/L | Standard Deviation 0 |
| MenC Group | Changes in Urinalysis Parameters | 0 Difference of g/L | Standard Deviation 0 |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Urinalysis Parameters | -1.6 Difference of μL | Standard Deviation 4.37 |
| LHD153R Formulation 2 Group | Changes in Urinalysis Parameters | 4.1 Difference of μL | Standard Deviation 10.52 |
| LHD153R Formulation 3 Group | Changes in Urinalysis Parameters | 5.9 Difference of μL | Standard Deviation 26.28 |
| LHD153R Formulation 4 Group | Changes in Urinalysis Parameters | -14.7 Difference of μL | Standard Deviation 58.15 |
| MenC Group | Changes in Urinalysis Parameters | -5.6 Difference of μL | Standard Deviation 13.65 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Urinalysis Parameters | -0.6 Difference of μL | Standard Deviation 2.5 |
| LHD153R Formulation 2 Group | Changes in Urinalysis Parameters | 1.6 Difference of μL | Standard Deviation 5.69 |
| LHD153R Formulation 3 Group | Changes in Urinalysis Parameters | -5.0 Difference of μL | Standard Deviation 12.65 |
| LHD153R Formulation 4 Group | Changes in Urinalysis Parameters | -8.4 Difference of μL | Standard Deviation 69.92 |
| MenC Group | Changes in Urinalysis Parameters | 0.0 Difference of μL | Standard Deviation 0 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Urinalysis Parameters | 0.000 Difference of g/L | Standard Deviation 0 |
| LHD153R Formulation 2 Group | Changes in Urinalysis Parameters | 0.000 Difference of g/L | Standard Deviation 0 |
| LHD153R Formulation 3 Group | Changes in Urinalysis Parameters | 0.000 Difference of g/L | Standard Deviation 0 |
| LHD153R Formulation 4 Group | Changes in Urinalysis Parameters | 0.000 Difference of g/L | Standard Deviation 0 |
| MenC Group | Changes in Urinalysis Parameters | 0.000 Difference of g/L | Standard Deviation 0 |
Primary
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
Population: Analysis was performed on the safety set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Urinalysis Parameters | 0.000 Difference of g/L | Standard Deviation 0 |
| LHD153R Formulation 2 Group | Changes in Urinalysis Parameters | 0.000 Difference of g/L | Standard Deviation 0 |
| LHD153R Formulation 3 Group | Changes in Urinalysis Parameters | 0.000 Difference of g/L | Standard Deviation 0 |
| LHD153R Formulation 4 Group | Changes in Urinalysis Parameters | 0.047 Difference of g/L | Standard Deviation 0.188 |
| MenC Group | Changes in Urinalysis Parameters | 0.000 Difference of g/L | Standard Deviation 0 |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LHD153R Formulation 1 Group | Changes in Urinalysis Parameters | -1.3 Difference of μL | Standard Deviation 3.42 |
| LHD153R Formulation 2 Group | Changes in Urinalysis Parameters | 3.1 Difference of μL | Standard Deviation 8.14 |
| LHD153R Formulation 3 Group | Changes in Urinalysis Parameters | -1.3 Difference of μL | Standard Deviation 17.46 |
| LHD153R Formulation 4 Group | Changes in Urinalysis Parameters | -14.7 Difference of μL | Standard Deviation 64.92 |
| MenC Group | Changes in Urinalysis Parameters | -3.8 Difference of μL | Standard Deviation 12.58 |
Primary
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
Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| LHD153R Formulation 1 Group | Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup | 8.70 Ratio |
| LHD153R Formulation 2 Group | Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup | 6.52 Ratio |
| LHD153R Formulation 3 Group | Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup | 16.56 Ratio |
| LHD153R Formulation 4 Group | Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup | 10.57 Ratio |
| MenC Group | Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup | 11.32 Ratio |
Primary
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
Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unbliding or analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| LHD153R Formulation 1 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | 96.61 Titer |
| LHD153R Formulation 2 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | 55.05 Titer |
| LHD153R Formulation 3 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | 101.77 Titer |
| LHD153R Formulation 4 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | 56.31 Titer |
| MenC Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | 70.38 Titer |
Primary
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)
Population: Analysis was performed on the Per Protocol Set (PPS) which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unbliding or analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| LHD153R Formulation 1 Group | Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC) | 11.40 Titer |
| LHD153R Formulation 2 Group | Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC) | 8.52 Titer |
| LHD153R Formulation 3 Group | Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC) | 6.09 Titer |
| LHD153R Formulation 4 Group | Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC) | 5.23 Titer |
| MenC Group | Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC) | 6.17 Titer |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 10 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 6 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 14 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 14 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 13 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 3 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 5 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 11 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 6 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 10 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 14 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 2 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 14 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 2 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 13 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 11 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 11 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 4 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 4 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 14 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 3 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 3 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 13 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 13 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 14 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 14 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 13 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 12 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 13 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 2 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 14 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 13 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 14 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 14 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 13 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 3 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 3 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 12 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 13 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 3 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 3 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 10 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 14 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 4 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 4 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 3 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 14 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 9 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 12 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 13 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 14 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 14 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 12 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 11 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 12 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 14 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 12 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 2 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 13 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 2 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 3 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 13 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 14 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 13 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 14 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 14 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 2 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 2 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 14 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 2 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 14 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 14 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 14 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 14 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 5 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 3 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 13 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 3 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 12 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 9 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 14 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 13 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 11 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 14 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 5 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 14 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 10 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 4 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 13 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 14 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 14 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 13 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 10 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 12 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 14 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 14 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | No change | 13 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Low | 2 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Low | 2 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Normal | 2 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | No change | 12 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Bicarbonate | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | High | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | No change | 14 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | High | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Basophils | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Protein | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine Glucose | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | High | 2 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | No change | 14 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Urine RBC | Normal | 2 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Eosinophils | No change | 14 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hemoglobin | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Neutrophils | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Monocytes | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | No change | 14 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Normal | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | No change | 13 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Hematocrit | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | K | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Low | 2 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Cl | Normal | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | RBC | No change | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | Normal | 2 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | No change | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CRP | High | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Lymphocytes | Low | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Na | High | 0 Participants |
Primary
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)
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 12 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 4 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 13 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 3 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 12 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 4 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 8 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 8 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 3 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 15 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 13 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 1 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
Primary
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
Population: Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 15 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 9 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 7 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 12 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 15 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 4 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 8 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 7 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 15 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 15 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 12 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 1 | 3 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 4 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | CREA | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | None | 16 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | ALT | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | AST | Grade 2 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | HGB | None | 13 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Platelets | Grade 1 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | BUN | Grade 3 | 0 Participants |
| MenC Group | Number of Subjects With Abnormal Laboratory Parameter Values | Leukocytes | Grade 2 | 0 Participants |
Primary
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
Population: Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and had post-vaccination unsolicited adverse event data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any NOCDs | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any SAEs | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AESIs | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any MAAEs | 2 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any NOCDs | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any MAAEs | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AESIs | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any SAEs | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any SAEs | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any MAAEs | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any NOCDs | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AESIs | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AESIs | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any SAEs | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any NOCDs | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any MAAEs | 3 Participants |
| MenC Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AEs leading to withdrawal | 0 Participants |
| MenC Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any NOCDs | 0 Participants |
| MenC Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any SAEs | 0 Participants |
| MenC Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AESIs | 0 Participants |
| MenC Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any MAAEs | 0 Participants |
Primary
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)
Population: Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and had post-vaccination unsolicited adverse events data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any NOCDs | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any SAEs | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AESIs | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any MAAEs | 5 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any NOCDs | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any MAAEs | 9 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AESIs | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any SAEs | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any SAEs | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any MAAEs | 5 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any NOCDs | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AESIs | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AESIs | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any SAEs | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any NOCDs | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any MAAEs | 5 Participants |
| MenC Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AEs leading to withdrawal | 0 Participants |
| MenC Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any NOCDs | 0 Participants |
| MenC Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any SAEs | 1 Participants |
| MenC Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any AESIs | 0 Participants |
| MenC Group | Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. | Any MAAEs | 8 Participants |
Primary
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
Population: Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and had post-vaccination unsolicited adverse events data. Data for this endpoint was analyzed from Day 1 to study termination (Day 366). Data from day of signed informed consent till Day 1(as per protocol) were not collected.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LHD153R Formulation 1 Group | 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). | Any NOCDs | 0 Participants |
| LHD153R Formulation 1 Group | 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). | Any SAEs | 0 Participants |
| LHD153R Formulation 1 Group | 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). | Any AESIs | 0 Participants |
| LHD153R Formulation 1 Group | 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). | Any MAAEs | 6 Participants |
| LHD153R Formulation 1 Group | 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). | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 2 Group | 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). | Any NOCDs | 0 Participants |
| LHD153R Formulation 2 Group | 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). | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 2 Group | 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). | Any MAAEs | 9 Participants |
| LHD153R Formulation 2 Group | 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). | Any AESIs | 0 Participants |
| LHD153R Formulation 2 Group | 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). | Any SAEs | 0 Participants |
| LHD153R Formulation 3 Group | 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). | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 3 Group | 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). | Any SAEs | 0 Participants |
| LHD153R Formulation 3 Group | 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). | Any MAAEs | 5 Participants |
| LHD153R Formulation 3 Group | 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). | Any NOCDs | 0 Participants |
| LHD153R Formulation 3 Group | 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). | Any AESIs | 0 Participants |
| LHD153R Formulation 4 Group | 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). | Any AESIs | 0 Participants |
| LHD153R Formulation 4 Group | 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). | Any SAEs | 0 Participants |
| LHD153R Formulation 4 Group | 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). | Any NOCDs | 0 Participants |
| LHD153R Formulation 4 Group | 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). | Any AEs leading to withdrawal | 0 Participants |
| LHD153R Formulation 4 Group | 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). | Any MAAEs | 8 Participants |
| MenC Group | 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). | Any AEs leading to withdrawal | 0 Participants |
| MenC Group | 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). | Any NOCDs | 0 Participants |
| MenC Group | 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). | Any SAEs | 1 Participants |
| MenC Group | 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). | Any AESIs | 0 Participants |
| MenC Group | 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). | Any MAAEs | 8 Participants |
Primary
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
Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Arthralgia | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Induration | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Pain | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Swelling | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Erythema | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Chills | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Diarrhea | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Fatigue | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Fever | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Headache | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Myalgia | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Nausea | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Rash | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Urticaria | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Vomiting | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Rash | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Headache | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Fever | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Urticaria | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Fatigue | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Arthralgia | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Swelling | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Induration | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Erythema | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Nausea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Chills | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Pain | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Vomiting | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Myalgia | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Diarrhea | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Rash | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Swelling | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Arthralgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Chills | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Diarrhea | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Fatigue | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Urticaria | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Fever | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Headache | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Myalgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Nausea | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Erythema | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Vomiting | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Induration | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Pain | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Headache | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Vomiting | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Rash | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Myalgia | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Chills | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Nausea | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Swelling | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Erythema | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Pain | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Fatigue | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Arthralgia | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Fever | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Urticaria | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Diarrhea | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Induration | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Nausea | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Headache | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Urticaria | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Arthralgia | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Induration | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Fatigue | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Loss of Appetite | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Vomiting | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Chills | 1 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Fever | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Erythema | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Myalgia | 1 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Diarrhea | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Rash | 1 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Swelling | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) | Any Pain | 0 Participants |
Primary
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)
Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and provided post-vaccination solicited local and systemic symptoms data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 2 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 6 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 3 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 3 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 7 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 3 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 5 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 5 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 5 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 6 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 2 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 1 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 2 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 1 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 3 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 10 Participants |
Primary
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
Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 2 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 4 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 2 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 4 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 1 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 1 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 0 Participants |
Primary
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
Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 4 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 2 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 3 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 5 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 2 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 1 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 0 Participants |
Primary
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)
Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported local and systemic symptoms
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 3 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 3 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 6 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 3 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 3 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 5 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 5 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 8 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 2 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 3 Participants |
Primary
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)
Population: Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported solicited local and systemic symptoms
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 3 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 5 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 1 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 2 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| LHD153R Formulation 1 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 2 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 7 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 3 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 1 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 3 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 5 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 1 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 6 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 5 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 4 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 3 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 2 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 5 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Headache | 10 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Rash | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Pain | 16 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Loss of Appetite | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Chills | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fever | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Vomiting | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Analgesic/Antipyretics Use | 1 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Myalgia | 2 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Arthralgia | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Diarrhea | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Swelling | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Erythema | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Urticaria | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Nausea | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Induration | 0 Participants |
| MenC Group | Number of Subjects With Any Solicited Local and Systemic AEs | Any Fatigue | 3 Participants |
Primary
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
Population: Analysis was performed on the Unsolicited Safety Set which included all enrolled subjects who received a study vaccination and provided post-vaccination unsolicited adverse event data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LHD153R Formulation 1 Group | Number of Subjects With Any Unsolicited AEs | 4 Participants |
| LHD153R Formulation 2 Group | Number of Subjects With Any Unsolicited AEs | 2 Participants |
| LHD153R Formulation 3 Group | Number of Subjects With Any Unsolicited AEs | 1 Participants |
| LHD153R Formulation 4 Group | Number of Subjects With Any Unsolicited AEs | 4 Participants |
| MenC Group | Number of Subjects With Any Unsolicited AEs | 4 Participants |
Secondary
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
Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 29 | 15.946 μg/mL |
| LHD153R Formulation 1 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 1 (pre-dose) | 0.287 μg/mL |
| LHD153R Formulation 1 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 8 | 2.005 μg/mL |
| LHD153R Formulation 1 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 181 | 5.201 μg/mL |
| LHD153R Formulation 2 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 8 | 2.169 μg/mL |
| LHD153R Formulation 2 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 1 (pre-dose) | 0.407 μg/mL |
| LHD153R Formulation 2 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 181 | 5.556 μg/mL |
| LHD153R Formulation 2 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 29 | 12.753 μg/mL |
| LHD153R Formulation 3 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 1 (pre-dose) | 0.207 μg/mL |
| LHD153R Formulation 3 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 181 | 7.131 μg/mL |
| LHD153R Formulation 3 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 8 | 1.668 μg/mL |
| LHD153R Formulation 3 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 29 | 19.322 μg/mL |
| LHD153R Formulation 4 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 1 (pre-dose) | 0.107 μg/mL |
| LHD153R Formulation 4 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 181 | 7.570 μg/mL |
| LHD153R Formulation 4 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 29 | 21.944 μg/mL |
| LHD153R Formulation 4 Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 8 | 2.897 μg/mL |
| MenC Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 181 | 3.432 μg/mL |
| MenC Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 1 (pre-dose) | 0.199 μg/mL |
| MenC Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 8 | 1.445 μg/mL |
| MenC Group | Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) | Day 29 | 9.207 μg/mL |
Secondary
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
Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| LHD153R Formulation 1 Group | GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | Day 8/Day 1 | 2.93 Ratio |
| LHD153R Formulation 1 Group | GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | Day 181/Day 1 | 9.29 Ratio |
| LHD153R Formulation 2 Group | GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | Day 8/Day 1 | 1.47 Ratio |
| LHD153R Formulation 2 Group | GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | Day 181/Day 1 | 8.30 Ratio |
| LHD153R Formulation 3 Group | GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | Day 8/Day 1 | 2.16 Ratio |
| LHD153R Formulation 3 Group | GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | Day 181/Day 1 | 13.40 Ratio |
| LHD153R Formulation 4 Group | GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | Day 181/Day 1 | 11.51 Ratio |
| LHD153R Formulation 4 Group | GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | Day 8/Day 1 | 2.64 Ratio |
| MenC Group | GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | Day 8/Day 1 | 3.35 Ratio |
| MenC Group | GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup | Day 181/Day 1 | 9.53 Ratio |
Secondary
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
Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| LHD153R Formulation 1 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | Day 8 | 30.86 Titer |
| LHD153R Formulation 1 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | Day 181 | 98.79 Titer |
| LHD153R Formulation 2 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | Day 8 | 12.18 Titer |
| LHD153R Formulation 2 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | Day 181 | 68.89 Titer |
| LHD153R Formulation 3 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | Day 8 | 13.58 Titer |
| LHD153R Formulation 3 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | Day 181 | 83.59 Titer |
| LHD153R Formulation 4 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | Day 181 | 63.13 Titer |
| LHD153R Formulation 4 Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | Day 8 | 15.47 Titer |
| MenC Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | Day 8 | 21.30 Titer |
| MenC Group | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | Day 181 | 59.67 Titer |
Secondary
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
Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 8 | 68.8 Percentage of subjects |
| LHD153R Formulation 1 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 181 | 87.5 Percentage of subjects |
| LHD153R Formulation 1 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 29 | 93.8 Percentage of subjects |
| LHD153R Formulation 2 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 29 | 81.3 Percentage of subjects |
| LHD153R Formulation 2 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 8 | 50.0 Percentage of subjects |
| LHD153R Formulation 2 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 181 | 75.0 Percentage of subjects |
| LHD153R Formulation 3 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 29 | 100.0 Percentage of subjects |
| LHD153R Formulation 3 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 8 | 68.8 Percentage of subjects |
| LHD153R Formulation 3 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 181 | 100.0 Percentage of subjects |
| LHD153R Formulation 4 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 8 | 68.8 Percentage of subjects |
| LHD153R Formulation 4 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 181 | 100.0 Percentage of subjects |
| LHD153R Formulation 4 Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 29 | 100.0 Percentage of subjects |
| MenC Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 29 | 87.5 Percentage of subjects |
| MenC Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 8 | 62.5 Percentage of subjects |
| MenC Group | Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA | Day 181 | 86.7 Percentage of subjects |
Secondary
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
Population: Analysis was performed on the PPS which included subjects who received a study vaccination and provided efficacy or immunogenicity data at relevant time points and who were not excluded due to reasons defined prior to unblinding or analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LHD153R Formulation 1 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 8 | 31.3 Percentage of subjects |
| LHD153R Formulation 1 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 181 | 75.0 Percentage of subjects |
| LHD153R Formulation 1 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 29 | 75.0 Percentage of subjects |
| LHD153R Formulation 2 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 29 | 56.3 Percentage of subjects |
| LHD153R Formulation 2 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 8 | 37.5 Percentage of subjects |
| LHD153R Formulation 2 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 181 | 56.3 Percentage of subjects |
| LHD153R Formulation 3 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 29 | 81.3 Percentage of subjects |
| LHD153R Formulation 3 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 8 | 31.3 Percentage of subjects |
| LHD153R Formulation 3 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 181 | 87.5 Percentage of subjects |
| LHD153R Formulation 4 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 8 | 33.3 Percentage of subjects |
| LHD153R Formulation 4 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 181 | 75.0 Percentage of subjects |
| LHD153R Formulation 4 Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 29 | 68.8 Percentage of subjects |
| MenC Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 29 | 75.0 Percentage of subjects |
| MenC Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 8 | 37.5 Percentage of subjects |
| MenC Group | Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). | Day 181 | 80.0 Percentage of subjects |