| 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. | 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. | Posted | | Count of Participants | | Participants | | Within 30 minutes of vaccination (Min) at Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. | | OG004 | MenC Group | Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine. |
| | Units | Counts |
|---|
| Participants | - OG00016
- OG00116
- OG00216
- OG003
|
| | Title | Denominators | Categories |
|---|
| Any Erythema | | |
| |
| 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. | Analysis was performed on the Solicited Safety Set which included all enrolled subjects who received a study vaccination and reported local and systemic symptoms | Posted | | Count of Participants | | Participants | | From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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 | Posted | | Count of Participants | | Participants | | From Day 5 to Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | LHD153R Formulation 3 Group |
|
| 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. | 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 | Posted | | Count of Participants | | Participants | | From Day 8 to Day 14 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 |
|
| 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. | 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 | Posted | | Count of Participants | | Participants | | From Day 1 to Day 8 (excluding 30 minutes immediately after vaccination) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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 | Posted | | Count of Participants | | Participants | | From Day 1 to Day 14 (excluding 30 minutes immediately after any vaccination) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | From Day 1 to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | LHD153R Formulation 2 Group |
|
| 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. | 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. | Posted | | Count of Participants | | Participants | | From Day 1 to Day 366 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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 | 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. | Posted | | Count of Participants | | Participants | | From Day 1 to Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | LHD153R Formulation 2 Group | |
|
| 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 | 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. | Posted | | Count of Participants | | Participants | | From Day 29 up to study end (Day 366) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | LHD153R Formulation 2 Group |
|
| 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). | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | mmol/L | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of mmol/L | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data. | Posted | | Mean | Standard Deviation | Difference of mmol/L | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of mmol/L | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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) | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | μmol/L | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of μmol/L | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of μmol/L | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of μmol/L | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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). | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | IU/L | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of IU/L | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of IU/L | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of IU/L | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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). | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | mg/L | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of mg/L | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of mg/L | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | Analysis was performed on the Overall Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of mg/L | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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) | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | 10^9/L | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of 10^9/L | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of 10^9/L | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of 10^9/L | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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). | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | 10^12/L | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of 10^12/L | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of 10^12/L | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of 10^12/L | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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). | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | L/L | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | LHD153R Formulation 4 Group |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of L/L | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of L/L | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of L/L | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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). | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | g/L | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | LHD153R Formulation 4 Group |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of g/L | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of g/L | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of g/L | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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). | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | μL | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of μL | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of μL | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of μL | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| Primary | Absolute Values for Urinalysis Parameters- Urine Glucose | The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | mmol/L | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | LHD153R Formulation 4 Group |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Difference of mmol/L | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Difference of mmol/L | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | Difference of mmol/L | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Primary | Absolute Values for Urinalysis Parameters- Urine Protein | The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L | 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. | Posted | | Mean | Standard Deviation | g/L | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | LHD153R Formulation 4 Group |
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| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of g/L | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
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| 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. | Analysis was performed on the safety set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of g/L | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
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| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Mean | Standard Deviation | Difference of g/L | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
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| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Count of Participants | | Participants | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Count of Participants | | Participants | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Count of Participants | | Participants | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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 | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Count of Participants | | Participants | | At Day 1 (post-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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 | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Count of Participants | | Participants | | At Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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 | Analysis was performed on the Safety Set which included all enrolled subjects who received a study vaccination and had available safety laboratory data | Posted | | Count of Participants | | Participants | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 1 (pre-dose) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Primary | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 |
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| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | At Day 29 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
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| Secondary | hSBA GMTs Against N. Meningitidis Serogroup C (MenC) | The antibody concentrations were assessed by hSBA directed against MenC and expressed as GMTs. | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Titer | | At Day 8 and Day 181 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | |
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| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | At Day 8 and Day 181 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | 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. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | At Day 8, Day 29 and Day 181 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | LHD153R Formulation 3 Group | |
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| 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). | 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. | Posted | | Geometric Mean | 95% Confidence Interval | μg/mL | | At Day 1 (pre-dose), Day 8, Day 29 and Day 181 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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). | 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. | Posted | | Number | 95% Confidence Interval | Percentage of subjects | | At Day 8, Day 29 and Day 181 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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