A Phase 1, Randomized, Observer-Blind, Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine Compared to Aluminium Hydroxide Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 Years of Age).

Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs)

时间窗: 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

时间窗: From Day 1 to Day 14 (excluding 30 minutes immediately after any 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

时间窗: 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).

时间窗: 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.

时间窗: From Day 29 up to study end (Day 366)

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

Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)

时间窗: 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 Hematology Parameters- Red Blood Cells (RBC)

时间窗: 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 Urinalysis Parameters- Urine Erythrocytes (Urine RBC)

时间窗: 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).

Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC)

时间窗: At Day 1 (pre-dose)

The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.

Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate.

时间窗: 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).

Absolute Values for Clinical Serum Chemistry Parameters-Creatinine

时间窗: 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 Hematology Parameters- Hematocrit

时间窗: 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 Urinalysis Parameters- Urine Glucose

时间窗: At Day 1 (pre-dose)

The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L.

Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP)

时间窗: 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.

时间窗: 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)

Absolute Values for Hematology Parameters- Hemoglobin (HGB)

时间窗: 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 Protein

时间窗: At Day 1 (pre-dose)

The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L

hSBA GMTs Against N. Meningitidis Serogroup C (MenC)

时间窗: At Day 29

The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.

Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup

时间窗: At Day 29

GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose).

Changes in Hematology Parameters

时间窗: At Day 29

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.

Changes in Clinical Serum Chemistry Parameters

时间窗: At Day 29

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.

Changes in Urinalysis Parameters

时间窗: At Day 29

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.

Number of Subjects With Abnormal Laboratory Parameter Values

时间窗: At Day 29

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.