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Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02639351
Recruitment Status : Completed
First Posted : December 24, 2015
Results First Posted : June 7, 2019
Last Update Posted : June 28, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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).

Condition or disease Intervention/treatment Phase
Infections, Meningococcal Biological: Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R Biological: Investigational MenC-CRM adjuavnted with 25 ug of LHD153R Biological: Investigational MenC-CRM adjuavnted with 50 ug of LHD153R Biological: Investigational MenC-CRM adjuavnted with 100 ug of LHD153R Biological: Meningococcal C-CRM Conjugate Vaccine (MenC-CRM) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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).
Actual Study Start Date : March 1, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LHD153R Formulation 1 Group
Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 12.5 ug of LHD153R.
Biological: Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R
Intramuscular (IM) vaccination of 1 dose of 0.5 mL

Experimental: LHD153R Formulation 2 Group
Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 25 ug of LHD153R.
Biological: Investigational MenC-CRM adjuavnted with 25 ug of LHD153R
IM vaccination of 1 dose of 0.5 mL

Experimental: LHD153R Formulation 3 Group
Healthy subjects aged 18 to 45 years who received a single dose of investigational MenC-CRM vaccine adjuvanted with 50 ug of LHD153R.
Biological: Investigational MenC-CRM adjuavnted with 50 ug of LHD153R
IM vaccination of 1 dose of 0.5 mL

Experimental: 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.
Biological: Investigational MenC-CRM adjuavnted with 100 ug of LHD153R
IM vaccination of 1 dose of 0.5 mL

Active Comparator: MenC Group
Healthy subjects aged 18 to 45 years who received a single dose of MenC-CRM vaccine.
Biological: Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)
IM vaccination of 1 dose of 0.5 mL




Primary Outcome Measures :
  1. Number of Subjects With Any Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Within 30 minutes of vaccination (Min) at Day 1 ]
    Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature greater than or equal to (≥) 38 degrees Celsius (°C), as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade.

  2. Number of Subjects With Any Solicited Local and Systemic AEs [ Time Frame: From Day 1 to Day 4 (excluding 30 minutes immediately after vaccination) ]
    Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.

  3. Number of Subjects With Any Solicited Local and Systemic AEs [ Time Frame: From Day 5 to Day 8 ]
    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.

  4. Number of Subjects With Any Solicited Local and Systemic AEs [ Time Frame: From Day 8 to Day 14 ]
    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.

  5. Number of Subjects With Any Solicited Local and Systemic AEs [ Time Frame: From Day 1 to Day 8 (excluding 30 minutes immediately after vaccination) ]
    Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.

  6. Number of Subjects With Any Solicited Local and Systemic AEs [ Time Frame: From Day 1 to Day 14 (excluding 30 minutes immediately after any vaccination) ]
    Assessed solicited local symptoms were injection site erythema, induration, pain and swelling. Any erythema/induration/swelling = erythema/induration/swelling spreading beyond 25 mm of injection site. Any pain = occurrence of the symptom regardless of intensity grade. Assessed solicited systemic symptoms were arthralgia, chills, diarrhea, fatigue, fever defined as body temperature ≥ 38 °C, as measured orally, headache, loss of appetite, myalgia, nausea, rash, urticaria and vomiting. Any systemic symptom = occurrence of the symptom regardless of intensity grade. Other solicited data included: Analgesic/Antipyretics Use.

  7. Number of Subjects With Any Unsolicited AEs [ Time Frame: From Day 1 to Day 29 ]
    An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment. Therefore, an AE can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product. This definition includes intercurrent illnesses or injuries and exacerbation of pre-existing conditions. Unsolicited adverse event were defined as symptoms that were not solicited using a Subject Diary and that were spontaneously communicated by a subject who has signed the informed consent. Unsolicited AEs were collected through the Day 29 visit and the analysis was performed for Day 1-29 time frame, instead of Day 1-14 as required by protocol.

  8. 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). [ Time Frame: From Day 1 to Day 366 ]
    SAEs are untoward medical occurrences that at any dose resulted in death,was life-threatening,required/prolonged hospitalization,persistent/significant disability/incapacity,congenital anomaly/in important & significant medical event that could jeopardize the subject/could required intervention to prevent one of the other outcomes mentioned above.MAAEs are AEs that lead to a visit to a healthcare provider.NOCDs are adverse events that represent new diagnosis of a chronic medical condition that was not present/suspected in a subject prior to study enrolment.AESIs were defined according to MedDRA preferred terms.Certain AESIs are monitored after administration of immunostimulatory agents.These are pre-defined & include AEs in the SOCs of Gastrointestinal disorders,Liver disorders,Metabolic diseases,Musculo-skeletal disorders,Neuroinflammatory disorders,Skin disorders,Vasculitides & others.

  9. Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. [ Time Frame: From Day 1 to Day 29 ]
    SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastrointestinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others

  10. Number of Subjects With Any SAEs, MAAEs, AEs Leading to Study Withdrawal, NOCDs and AESIs. [ Time Frame: From Day 29 up to study end (Day 366) ]
    SAEs were defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly or in an important and significant medical event that could jeopardize the subject or could requiered intervention to prevent one of the other outcomes mentioned above. MAAEs were defined as an AE that lead to a visit to a healthcare provider. NOCDs were defined as AEs leading to study or vaccine withdrawal. AESIs were defined according to MedDRA preferred terms.Certain AEs of special interest (AESIs) are monitored after the administration of immunostimulatory agents. These are pre-defined and include AEs in the SOCs of Gastroin-testinal disorders, Liver disorders, Metabolic diseases, Musculo-skeletal disorders, Neuroinflammatory disorders, Skin disorders, Vasculitides and others

  11. Absolute Values for Clinical Serum Chemistry Parameters- Sodium (Na), Potassium (K), Chlorine (Cl), Blood Urea Nitrogen (BUN) and Bicarbonate. [ Time Frame: At Day 1 (pre-dose) ]
    Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in millimoles per liter (mmol/L).

  12. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 1 (post-dose) ]
    Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

  13. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 8 ]
    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.

  14. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 29 ]
    Analysis was performed on blood samples collected at Day 29 for the following parameters: Na, K, Cl, BUN and bicarbonate in mmol/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

  15. Absolute Values for Clinical Serum Chemistry Parameters-Creatinine [ Time Frame: At Day 1 (pre-dose) ]
    Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: Creatinine (CREA) in micro mole per liter (μmol/L)

  16. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 1 (post-dose) ]
    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.

  17. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 8 ]
    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.

  18. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 29 ]
    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.

  19. Absolute Values for Clinical Serum Chemistry Parameters- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) [ Time Frame: At Day 1 (pre-dose) ]
    Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: ALT and AST in International Units per liter (IU/L).

  20. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 1 (post-dose) ]
    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.

  21. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 8 ]
    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.

  22. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 29 ]
    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.

  23. Absolute Values for Clinical Serum Chemistry Parameters- C-reactive Protein (CRP) [ Time Frame: At Day 1 (pre-dose) ]
    Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: CRP in milligram per liter (mg/L).

  24. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 1 (post-dose) ]
    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.

  25. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 8 ]
    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.

  26. Changes in Clinical Serum Chemistry Parameters [ Time Frame: At Day 29 ]
    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.

  27. Absolute Values for Hematology Parameters- Basophils, Eosniophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Plateletes. [ Time Frame: At Day 1 (pre-dose) ]
    Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9 cells per liter (10^9/L)

  28. Changes in Hematology Parameters [ Time Frame: At Day 1 (post-dose) ]
    Analysis was performed on blood samples collected at Day 1 (post-dose) for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

  29. Changes in Hematology Parameters [ Time Frame: At Day 8 ]
    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.

  30. Changes in Hematology Parameters [ Time Frame: At Day 29 ]
    Analysis was performed on blood samples collected at Day 29 for the following parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets in 10^9/L. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

  31. Absolute Values for Hematology Parameters- Red Blood Cells (RBC) [ Time Frame: At Day 1 (pre-dose) ]
    Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: RBC in 10^12 cells per liter (10^12/L).

  32. Changes in Hematology Parameters [ Time Frame: At Day 1 (post-dose) ]
    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.

  33. Changes in Hematology Parameters [ Time Frame: At Day 8 ]
    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.

  34. Changes in Hematology Parameters [ Time Frame: At Day 29 ]
    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.

  35. Absolute Values for Hematology Parameters- Hematocrit [ Time Frame: At Day 1 (pre-dose) ]
    Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: hematocrit in liter per liter (L/L).

  36. Changes in Hematology Parameters [ Time Frame: At Day 1 (post-dose) ]
    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.

  37. Changes in Hematology Parameters [ Time Frame: At Day 8 ]
    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.

  38. Changes in Hematology Parameters [ Time Frame: At Day 29 ]
    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.

  39. Absolute Values for Hematology Parameters- Hemoglobin (HGB) [ Time Frame: At Day 1 (pre-dose) ]
    Analysis was performed on blood samples collected at Day 1 (pre-dose) for the following parameter: HGB in gram per liter (g/L).

  40. Changes in Hematology Parameters [ Time Frame: At Day 1 (post-dose) ]
    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.

  41. Changes in Hematology Parameters [ Time Frame: At Day 8 ]
    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.

  42. Changes in Hematology Parameters [ Time Frame: At Day 29 ]
    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.

  43. Absolute Values for Urinalysis Parameters- Urine Erythrocytes (Urine RBC) [ Time Frame: At Day 1 (pre-dose) ]
    Analysis was performed on urine samples collected at Day 1 (pre-dose) for the following parameter: Urine RBC in microliters (μL).

  44. Changes in Urinalysis Parameters [ Time Frame: At Day 1 (post-dose) ]
    Analysis was performed on urine samples collected at Day 1 (post-dose) for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 1 (post-dose) results.

  45. Changes in Urinalysis Parameters [ Time Frame: At Day 8 ]
    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.

  46. Changes in Urinalysis Parameters [ Time Frame: At Day 29 ]
    Analysis was performed on urine samples collected at Day 29 for the following parameter: Urine RBC in μL. The change was calculated as difference between the Day 1 (pre-dose) results and the Day 29 results.

  47. Absolute Values for Urinalysis Parameters- Urine Glucose [ Time Frame: At Day 1 (pre-dose) ]
    The absolute value for urinalysis was assessed for the following parameter: urine glucose in mmol/L.

  48. Changes in Urinalysis Parameters [ Time Frame: At Day 1 (post-dose) ]
    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.

  49. Changes in Urinalysis Parameters [ Time Frame: At Day 8 ]
    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.

  50. Changes in Urinalysis Parameters [ Time Frame: At Day 29 ]
    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.

  51. Absolute Values for Urinalysis Parameters- Urine Protein [ Time Frame: At Day 1 (pre-dose) ]
    The absolute value for urinalysis was assessed for the following parameter: urine protein in g/L

  52. Changes in Urinalysis Parameters [ Time Frame: At Day 1 (post-dose) ]
    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.

  53. Changes in Urinalysis Parameters [ Time Frame: At Day 8 ]
    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.

  54. Changes in Urinalysis Parameters [ Time Frame: At Day 29 ]
    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.

  55. Number of Subjects With Abnormal Laboratory Parameter Values [ Time Frame: At Day 1 (post-dose) ]
    The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.

  56. Number of Subjects With Abnormal Laboratory Parameter Values [ Time Frame: At Day 8 ]
    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.

  57. Number of Subjects With Abnormal Laboratory Parameter Values [ Time Frame: At Day 29 ]
    The abnormal laboratory parameters values were classified by the investigator as Normal (a value either low or high at baseline and normal post-baseline), High (a value either normal or low at baseline and high post-baseline), Low (a value either normal or high at baseline and low post-baseline) and No change.

  58. Number of Subjects With Abnormal Laboratory Parameter Values [ Time Frame: At Day 1 (post-dose) ]
    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

  59. Number of Subjects With Abnormal Laboratory Parameter Values [ Time Frame: At Day 8 ]
    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

  60. Number of Subjects With Abnormal Laboratory Parameter Values [ Time Frame: At Day 29 ]
    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

  61. Human Complement Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup C (MenC) [ Time Frame: At Day 1 (pre-dose) ]
    The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.

  62. hSBA GMTs Against N. Meningitidis Serogroup C (MenC) [ Time Frame: At Day 29 ]
    The antibody concentrations were assessed by hSBA directed against MenC serogroup and expressed as GMTs.

  63. Geometric Mean Ratio (GMR) of the Titers of Antibodies Measured by hSBA Against MenC Serogroup [ Time Frame: At Day 29 ]
    GMR of GMTs of antibodies against MenC was evaluated at Day 29 relative to Day 1 (pre-dose).


Secondary Outcome Measures :
  1. hSBA GMTs Against N. Meningitidis Serogroup C (MenC) [ Time Frame: At Day 8 and Day 181 ]
    The antibody concentrations were assessed by hSBA directed against MenC and expressed as GMTs.

  2. GMR of the GMTs of Antibodies Measured by hSBA Against MenC Serogroup [ Time Frame: At Day 8 and Day 181 ]
    GMR of GMTs of antibodies against MenC serogroup was evaluated at Day 8 and Day 181 relative to Day 1 (pre-dose).

  3. Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroup C (MenC). [ Time Frame: At Day 8, Day 29 and Day 181 ]
    The percentage of subjects who achieved hSBA seroresponse against MenC serogroup was evaluated at Day 8, Day 29 and Day 181 after vaccination. Seroresponse was defined as a post vaccination hSBA ≥ 8 for subjects with a baseline hSBA lower than (<) 4 or had an increase of at least 4 times the baseline hSBA level for subjects with pre vaccination hSBA ≥ 4.

  4. Concentrations of Antibodies Against MenC Serogroup Measured by Enzyme Linked Immunosorbent Assay (ELISA) [ Time Frame: At Day 1 (pre-dose), Day 8, Day 29 and Day 181 ]
    The antibody concentrations were assessed by ELISA and expressed as Geometric Mean Concentrations (GMCs) in microgram per mililiter (μg/mL).

  5. Percentage of Subjects With at Least a 4-fold Increase in Antibody Concentrations to MenC as Measured by ELISA [ Time Frame: At Day 8, Day 29 and Day 181 ]
    The percentage of subjects with at least a 4-fold increase in antibody concentrations to MenC serogroup as measured by ELISA were analysed at day 8, 29 and 181 relative to Day 1 (pre-dose).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female individuals of 18 through 45 years of age on the day of informed consent
  2. Healthy volunteers with good physical and mental health status, determined on the basis of the medical history, a physical examination and the results of the screening tests as judged by the investigator
  3. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
  4. Individuals who can comply with study procedures including follow-up
  5. Individuals that are able to understand, read and write German language
  6. Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.

Exclusion Criteria:

  1. Progressive, unstable or uncontrolled clinical conditions
  2. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study
  3. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
  4. Abnormal function of the immune system
  5. Received immunoglobulins or any blood products within 180 days prior to informed consent
  6. Received an investigational or non-registered medicinal product within 30 days prior to informed consent or intend to participate in another clinical study at any time during the conduct of this study
  7. Vulnerable subjects (e.g. persons kept in detention), study personnel or an immediate family or household member of study personnel, subjects with legal incapacity or limited legal capacity
  8. Any relevant deviation from the laboratory parameters at screening as judged by the investigator
  9. Previously received any vaccine that included a MenC antigen
  10. Previously suspected or confirmed disease caused by N. meningitides
  11. Had household contact with and/or intimate exposure to an individual with culture proven MenC
  12. A positive serum or urine pregnancy test prior to the study vaccine administration or are currently lactating.
  13. A positive drugs-of-abuse test prior to the study vaccine administration;
  14. Received any other vaccines within 30 days prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the administration of study vaccines
  15. Any other condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639351


Locations
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Germany
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
  Study Documents (Full-Text)

Documents provided by GlaxoSmithKline:
Study Protocol  [PDF] June 30, 2014
Statistical Analysis Plan  [PDF] January 23, 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02639351    
Other Study ID Numbers: 205496
V132_01EXP ( Other Identifier: Novartis )
2014-002430-31 ( EudraCT Number )
First Posted: December 24, 2015    Key Record Dates
Results First Posted: June 7, 2019
Last Update Posted: June 28, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections