Back to resultsSafety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R
Investigational MenC-CRM adjuavnted with 25 ug of LHD153R
Investigational MenC-CRM adjuavnted with 50 ug of LHD153R
Investigational MenC-CRM adjuavnted with 100 ug of LHD153R
Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal
Eligibility Criteria
Inclusion Criteria:
- Male or female individuals of 18 through 45 years of age on the day of informed consent
- Healthy volunteers with good physical and mental health status, determined on the basis of the medical history, a physical examination and the results of the screening tests as judged by the investigator
- Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
- Individuals who can comply with study procedures including follow-up
- Individuals that are able to understand, read and write German language
- Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.
Exclusion Criteria:
- Progressive, unstable or uncontrolled clinical conditions
- Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
- Abnormal function of the immune system
- Received immunoglobulins or any blood products within 180 days prior to informed consent
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent or intend to participate in another clinical study at any time during the conduct of this study
- Vulnerable subjects (e.g. persons kept in detention), study personnel or an immediate family or household member of study personnel, subjects with legal incapacity or limited legal capacity
- Any relevant deviation from the laboratory parameters at screening as judged by the investigator
- Previously received any vaccine that included a MenC antigen
- Previously suspected or confirmed disease caused by N. meningitides
- Had household contact with and/or intimate exposure to an individual with culture proven MenC
- A positive serum or urine pregnancy test prior to the study vaccine administration or are currently lactating.
- A positive drugs-of-abuse test prior to the study vaccine administration;
- Received any other vaccines within 30 days prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the administration of study vaccines
- Any other condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Arm Label
LHD153R Formulation 1 Group
LHD153R Formulation 2 Group
LHD153R Formulation 3 Group
LHD153R Formulation 4 Group
MenC Group
Arm Description
Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 12.5 ug of LHD153R.
Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 25 ug of LHD153R.
Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 50 ug of LHD153R.
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.
Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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).
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.
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.
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.
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)
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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)
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
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).
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.
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.
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.
Absolute Values for Urinalysis Parameters- Urine Glucose
The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L.
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.
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.
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.
Absolute Values for Urinalysis Parameters- Urine Protein
The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L
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.
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.
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.
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.
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.
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.
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
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
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
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.
hSBA GMTs Against N. Meningitidis Serogroup C (MenC)
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup
GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose).
Secondary Outcome Measures
hSBA GMTs Against N. Meningitidis Serogroup C (MenC)
The antibody concentrations were assessed by hSBA directed against MenC and expressed as GMTs.
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).
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.
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02639351
Brief Title
Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine
Official Title
A Phase 1, Randomized, Observer-Blind, Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine Compared to Aluminium Hydroxide Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 Years of Age).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 years of age).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LHD153R Formulation 1 Group
Arm Type
Experimental
Arm Description
Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 12.5 ug of LHD153R.
Arm Title
LHD153R Formulation 2 Group
Arm Type
Experimental
Arm Description
Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 25 ug of LHD153R.
Arm Title
LHD153R Formulation 3 Group
Arm Type
Experimental
Arm Description
Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 50 ug of LHD153R.
Arm Title
LHD153R Formulation 4 Group
Arm Type
Experimental
Arm Description
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.
Arm Title
MenC Group
Arm Type
Active Comparator
Arm Description
Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Intervention Type
Biological
Intervention Name(s)
Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R
Intervention Description
Intramuscular (IM) vaccination of 1 dose of 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Investigational MenC-CRM adjuavnted with 25 ug of LHD153R
Intervention Description
IM vaccination of 1 dose of 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Investigational MenC-CRM adjuavnted with 50 ug of LHD153R
Intervention Description
IM vaccination of 1 dose of 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Investigational MenC-CRM adjuavnted with 100 ug of LHD153R
Intervention Description
IM vaccination of 1 dose of 0.5 mL
Intervention Type
Biological
Intervention Name(s)
Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)
Intervention Description
IM vaccination of 1 dose of 0.5 mL
Primary Outcome Measure Information:
Title
Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs)
Description
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature greater than or equal to (≥) 38 degrees Celsius (°C), as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.
Time Frame
Within 30 minutes of vaccination (Min) at Day 1
Title
Number of Subjects With Any Solicited Local and Systemic AEs
Description
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Time Frame
From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination)
Title
Number of Subjects With Any Solicited Local and Systemic AEs
Description
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.
Time Frame
From Day 5 to Day 8
Title
Number of Subjects With Any Solicited Local and Systemic AEs
Description
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Time Frame
From Day 8 to Day 14
Title
Number of Subjects With Any Solicited Local and Systemic AEs
Description
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Time Frame
From Day 1 to Day 8 (excluding 30 minutes immediately after vaccination)
Title
Number of Subjects With Any Solicited Local and Systemic AEs
Description
Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.
Time Frame
From Day 1 to Day 14 (excluding 30 minutes immediately after any vaccination)
Title
Number of Subjects With Any Unsolicited AEs
Description
An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes intercurrent illnesses or injuries and exacerbation of pre-existing conditions. Unsolicited adverse event were defined as symptoms that were not solicited using a Subject Diary and that were spontaneously communicated by a subject who has signed the informed consent. Unsolicited AEs were collected through the Day 29 visit and the analysis was performed for Day 1-29 time frame, instead of Day 1-14 as required by protocol.
Time Frame
From Day 1 to Day 29
Title
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).
Description
SAEs are untoward medical occurrences that at any dose resulted in death,was life-threatening,required/prolonged hospitalization,persistent/significant disability/incapacity,congenital anomaly/in important & significant medical event that could jeopardize the subject/could required intervention to prevent one of the other outcomes mentioned above.MAAEs are AEs that lead to a visit to a healthcare provider.NOCDs are adverse events that represent new diagnosis of a chronic medical condition that was not present/suspected in a subject prior to study enrolment.AESIs were defined according to MedDRA preferred terms.Certain AESIs are monitored after administration of immunostimulatory agents.These are pre-defined & include AEs in the SOCs of Gastrointestinal disorders,Liver disorders,Metabolic diseases,Musculo-skeletal disorders,Neuroinflammatory disorders,Skin disorders,Vasculitides & others.
Time Frame
From Day 1 to Day 366
Title
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs.
Description
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastrointestinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others
Time Frame
From Day 1 to Day 29
Title
Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs.
Description
SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastroin-testinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others
Time Frame
From Day 29 up to study end (Day 366)
Title
Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate.
Description
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in millimoles per liter (mmol/L).
Time Frame
At Day 1 (pre-dose)
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 8 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time Frame
At Day 8
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 29 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time Frame
At Day 29
Title
Absolute Values for Clinical Serum Chemistry Parameters-Creatinine
Description
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: Creatinine (CREA) in micro mole per liter (μmol/L)
Time Frame
At Day 1 (pre-dose)
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 8 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time Frame
At Day 8
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 29 for the following parameter: CREA in μmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time Frame
At Day 29
Title
Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)
Description
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: ALT and AST in International Units per liter (IU/L).
Time Frame
At Day 1 (pre-dose)
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 8 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time Frame
At Day 8
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 29 for the following parameters: ALT and AST in IU/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time Frame
At Day 29
Title
Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP)
Description
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: CRP in milligram per liter (mg/L).
Time Frame
At Day 1 (pre-dose)
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 8 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time Frame
At Day 8
Title
Changes in Clinical Serum Chemistry Parameters
Description
Analysis was performed on blood samples collected at Day 29 for the following parameter: CRP in mg/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time Frame
At Day 29
Title
Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes.
Description
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9 cells per liter (10^9/L)
Time Frame
At Day 1 (pre-dose)
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 8 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time Frame
At Day 8
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 29 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time Frame
At Day 29
Title
Absolute Values for Hematology Parameters- Red Blood Cells (RBC)
Description
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: RBC in 10^12 cells per liter (10^12/L).
Time Frame
At Day 1 (pre-dose)
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 8 for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time Frame
At Day 8
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 29 for the following parameter: RBC in 10^12/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time Frame
At Day 29
Title
Absolute Values for Hematology Parameters- Hematocrit
Description
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: hematocrit in liter per liter (L/L).
Time Frame
At Day 1 (pre-dose)
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 8 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time Frame
At Day 8
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 29 for the following parameter: hematocrit in L/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time Frame
At Day 29
Title
Absolute Values for Hematology Parameters- Hemoglobin (HGB)
Description
Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: HGB in gram per liter (g/L).
Time Frame
At Day 1 (pre-dose)
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 8 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time Frame
At Day 8
Title
Changes in Hematology Parameters
Description
Analysis was performed on blood samples collected at Day 29 for the following parameter: HGB in g/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time Frame
At Day 29
Title
Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC)
Description
Analysis was performed on urine samples collected at Day 1 (pre-dose) for the following parameter: Urine RBC in microliters (μL).
Time Frame
At Day 1 (pre-dose)
Title
Changes in Urinalysis Parameters
Description
Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Urinalysis Parameters
Description
Analysis was performed on urine samples collected at Day 8 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 results.
Time Frame
At Day 8
Title
Changes in Urinalysis Parameters
Description
Analysis was performed on urine samples collected at Day 29 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.
Time Frame
At Day 29
Title
Absolute Values for Urinalysis Parameters- Urine Glucose
Description
The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L.
Time Frame
At Day 1 (pre-dose)
Title
Changes in Urinalysis Parameters
Description
Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Urinalysis Parameters
Description
Analysis was performed on urine samples collected at Day 8 (post-dose) for the following parameter: urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 8 (post-dose) results.
Time Frame
At Day 8
Title
Changes in Urinalysis Parameters
Description
Analysis was performed on urine samples collected at Day 29 (post-dose) for the following parameter: Urine glucose in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 (post-dose) results.
Time Frame
At Day 29
Title
Absolute Values for Urinalysis Parameters- Urine Protein
Description
The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L
Time Frame
At Day 1 (pre-dose)
Title
Changes in Urinalysis Parameters
Description
Analysis was performed on urine samples collected at day 1 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 1 (post-dose) results.
Time Frame
At Day 1 (post-dose)
Title
Changes in Urinalysis Parameters
Description
Analysis was performed on urine samples collected at day 8 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 8 (post-dose) results.
Time Frame
At Day 8
Title
Changes in Urinalysis Parameters
Description
Analysis was performed on urine samples collected at day 29 (post-dose) for the following parameter: urine protein in g/L. The change was calculated as difference between the day 1 (pre-dose) results and the day 29 (post-dose) results.
Time Frame
At Day 29
Title
Number of Subjects With Abnormal Laboratory Parameter Values
Description
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Time Frame
At Day 1 (post-dose)
Title
Number of Subjects With Abnormal Laboratory Parameter Values
Description
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Time Frame
At Day 8
Title
Number of Subjects With Abnormal Laboratory Parameter Values
Description
The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.
Time Frame
At Day 29
Title
Number of Subjects With Abnormal Laboratory Parameter Values
Description
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Time Frame
At Day 1 (post-dose)
Title
Number of Subjects With Abnormal Laboratory Parameter Values
Description
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Time Frame
At Day 8
Title
Number of Subjects With Abnormal Laboratory Parameter Values
Description
The abnormal laboratory parameters values were defined following the FDA CBER Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" dated September 2007, or the institution's normal ranges if they differ from CBER guidance
Time Frame
At Day 29
Title
Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC)
Description
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
Time Frame
At Day 1 (pre-dose)
Title
hSBA GMTs Against N. Meningitidis Serogroup C (MenC)
Description
The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.
Time Frame
At Day 29
Title
Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup
Description
GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose).
Time Frame
At Day 29
Secondary Outcome Measure Information:
Title
hSBA GMTs Against N. Meningitidis Serogroup C (MenC)
Description
The antibody concentrations were assessed by hSBA directed against MenC and expressed as GMTs.
Time Frame
At Day 8 and Day 181
Title
GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup
Description
GMR of GMTs of antibodies against MenC serogroup was evaluated at Day 8 and Day 181 relative to Day 1 (pre-dose).
Time Frame
At Day 8 and Day 181
Title
Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC).
Description
The percentage of subjects who achieved hSBA seroresponse against MenC serogroup was evaluated at Day 8, Day 29 and Day 181 after vaccination. Seroresponse was defined as a post vaccination hSBA ≥ 8 for subjects with a baseline hSBA lower than (<) 4 or had an increase of at least 4 times the baseline hSBA level for subjects with pre vaccination hSBA ≥ 4.
Time Frame
At Day 8, Day 29 and Day 181
Title
Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA)
Description
The antibody concentrations were assessed by ELISA and expressed as Geometric Mean Concentrations (GMCs) in microgram per mililiter (μg/mL).
Time Frame
At Day 1 (pre-dose), Day 8, Day 29 and Day 181
Title
Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA
Description
The percentage of subjects with at least a 4-fold increase in antibody concentrations to MenC serogroup as measured by ELISA were analysed at day 8, 29 and 181 relative to Day 1 (pre-dose).
Time Frame
At Day 8, Day 29 and Day 181
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female individuals of 18 through 45 years of age on the day of informed consent
Healthy volunteers with good physical and mental health status, determined on the basis of the medical history, a physical examination and the results of the screening tests as judged by the investigator
Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
Individuals who can comply with study procedures including follow-up
Individuals that are able to understand, read and write German language
Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.
Exclusion Criteria:
Progressive, unstable or uncontrolled clinical conditions
Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
Abnormal function of the immune system
Received immunoglobulins or any blood products within 180 days prior to informed consent
Received an investigational or non-registered medicinal product within 30 days prior to informed consent or intend to participate in another clinical study at any time during the conduct of this study
Vulnerable subjects (e.g. persons kept in detention), study personnel or an immediate family or household member of study personnel, subjects with legal incapacity or limited legal capacity
Any relevant deviation from the laboratory parameters at screening as judged by the investigator
Previously received any vaccine that included a MenC antigen
Previously suspected or confirmed disease caused by N. meningitides
Had household contact with and/or intimate exposure to an individual with culture proven MenC
A positive serum or urine pregnancy test prior to the study vaccine administration or are currently lactating.
A positive drugs-of-abuse test prior to the study vaccine administration;
Received any other vaccines within 30 days prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the administration of study vaccines
Any other condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
31669193
Citation
Gonzalez-Lopez A, Oostendorp J, Koernicke T, Fadini T, D'Oro U, Baker S, O'Hagan DT, Del Giudice G, Siena E, Finco O, Medini D. Adjuvant effect of TLR7 agonist adsorbed on aluminum hydroxide (AS37): A phase I randomized, dose escalation study of an AS37-adjuvanted meningococcal C conjugated vaccine. Clin Immunol. 2019 Dec;209:108275. doi: 10.1016/j.clim.2019.108275. Epub 2019 Oct 24.
Results Reference
derived
Learn more about this trial
Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine
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