Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Meningococcal C-CRM Conjugate Vaccine · 1 trial · 1 indication
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.
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.
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.
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.
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 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 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 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 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 blood samples collected at Day 1 (pre-dose) for the following parameter: CRP in milligram per liter (mg/L).
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 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 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 blood samples collected at Day 1 (pre-dose) for the following parameter: hematocrit in liter per liter (L/L).
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 urine samples collected at Day 1 (pre-dose) for the following parameter: Urine RBC in microliters (μL).
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.
The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L.
The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L
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.
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose).
| Arm | Type | Description |
|---|---|---|
| LHD153R Formulation 1 Group | EXPERIMENTAL | Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 12.5 ug of LHD153R. |
| LHD153R Formulation 2 Group | EXPERIMENTAL | Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 25 ug of LHD153R. |
| LHD153R Formulation 3 Group | EXPERIMENTAL | Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 50 ug of LHD153R. |
| LHD153R Formulation 4 Group | EXPERIMENTAL | 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. |
| MenC Group | ACTIVE_COMPARATOR | Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine. |
| Name | Type | Description |
|---|---|---|
| Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R | BIOLOGICAL | Intramuscular (IM) vaccination of 1 dose of 0.5 mL |
| Investigational MenC-CRM adjuavnted with 25 ug of LHD153R | BIOLOGICAL | IM vaccination of 1 dose of 0.5 mL |
| Investigational MenC-CRM adjuavnted with 50 ug of LHD153R | BIOLOGICAL | IM vaccination of 1 dose of 0.5 mL |
| Investigational MenC-CRM adjuavnted with 100 ug of LHD153R | BIOLOGICAL | IM vaccination of 1 dose of 0.5 mL |
| Meningococcal C-CRM Conjugate Vaccine (MenC-CRM) | BIOLOGICAL | IM vaccination of 1 dose of 0.5 mL |
Inclusion Criteria: 1. Male or female individuals of 18 through 45 years of age on the day of informed consent 2. Healthy volunteers with good physical and mental health status, determined on the basis of the medical history, a physical examination and the results of the screening tests as judged b...
Meningococcal C-CRM Conjugate Vaccine is an investigational vaccine being developed for the prevention of meningococcal infections. It is designed to generate an immune response against Neisseria meningitidis serogroup C, a bacterium that can cause serious illnesses such as meningitis and septicemia. The vaccine is currently in clinical development and has not yet been approved for use.
Meningococcal C-CRM Conjugate Vaccine is being developed by GSK plc, a global biopharmaceutical company headquartered in the United Kingdom. GSK trades on the London Stock Exchange and the New York Stock Exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
Meningococcal C-CRM Conjugate Vaccine is in Phase 1 clinical development. It is an investigational vaccine, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and ability to provoke an immune response. The Phase 1 trial has been completed, but the vaccine remains in early-stage development.
Meningococcal C-CRM Conjugate Vaccine has one completed Phase 1 clinical trial, registered as NCT02639351. The trial, titled 'Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine,' enrolled 80 healthy adult volunteers aged 18 years and older in Germany. The study was active-controlled and randomized, though it was not double-blinded.
Meningococcal C-CRM Conjugate Vaccine works by presenting a fragment of the meningococcal C bacterium, linked to a carrier protein called CRM197, to the immune system. This conjugate design is intended to elicit a strong T-cell-dependent immune response, leading to the production of antibodies that can neutralize the bacteria. The vaccine also contains an aluminium hydroxide adjuvant to enhance the immune response.
Meningococcal C-CRM Conjugate Vaccine is a specific type of meningococcal C vaccine that uses CRM197 as the carrier protein in its conjugate formulation. It is designed to protect against serogroup C meningococcal disease. While it shares the same target as other meningococcal C vaccines, its specific formulation and adjuvant system distinguish it from other products in this class.