Healthy subjects without known medical conditions will be vaccinated against Neisseria meningitidis serogroup C. Active prevention of meningococcal C disease caused by Neisseria meningitidis serogroup C.
Conditions
Interventions
Pharmaceutical Form: Powder and solvent for suspension for injection
Other descriptive name: N.meningitidis serogroup C (strain C11) oligosaccharide conjugated to C diphtheriae CRM197
Sponsors
Chiron S.r.l.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. healthy children aged 12-13 months (inclusive) who took part in the previous study to establish the kinetics of the B cell response to MenC vaccine at 2, 3 and 4 months (study M14P5, Eudract number 2004-004962-33) 2. available for the visits scheduled in the study; 3. in good health as determined by: - medical history - clinical judgment of the investigator - pre-vaccination check performed by a physician if indicated by medical history 4. whose parents can give written informed consent for the child to be enrolled in the study. Informed consent must be obtained for all subjects before enrolment into the study. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Children whose parents have not given or are unwilling or unable to give written informed consent to their child’s participation in the study 2. Known hypersensitivity to any vaccines or constituents 3. Unacceptable concurrent illnesses or conditions - children a. with a severe acute or chronic illness; with any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or with any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease; b. with a genetic anomaly; c. with any immunodeficiency, including use of systemic corticosteroids d. with previous clinical or bacteriological diagnosis of meningitis, or with a history of household contact or intimate exposure to an individual with culture proven Neisseria meningitidis disease; e. with a known bleeding diathesis, or any condition associated with a prolonged bleeding time; 4. Prohibited prior or concomitant medications a. Any immunizations, with the exception of those received in the initial phase of the study, BCG, hepatitis B or Hib; b. Receipt of immunoglobulin; c. Receipt of any blood products; 5. Participation in any other clinical trial either currently or in the previous month; 6. Inability to adhere to the protocol, including plans to move from the area; 7. Other With any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish whether memory B cells persist in the blood at least one year after primary immunisation with Menjugate® at 2, 3 and 4 months of age as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution. To establish at which day meningococcal C specific B cells are detectable in the blood of healthy children after a booster immunisation with Menjugate®, as determined by meningococcal C specific B-cell ELISpot assay or limiting dilution. To determine the immune response to Menjugate®, as determined by Neisseria meningitidis serogroup C specific serum bactericidal activity using human complement (hSBA) or baby rabbit complement (rSBA) measured 4 weeks after the booster immunisation. ;Secondary Objective: Persistence of the immune response to a primary course of Menjugate®, as determined by analysis of N. meningitidis serogroup C specific ELISA on serum obtained prior to the booster immunisation; Kinetics of the immune response to a booster dose of Menjugate®, as determined by analysis of N. meningitidis serogroup C specific ELISA on serum obtained at variable times in the week following the booster immunisation; Persistence of the immune response to a primary course of Menjugate®, as determined by analysis of serum obtained prior to the booster immunisation for N. meningitidis serogroup C specific hSBA; Immune response to Menjugate®, as determined by N. meningitidis serogroup C specific ELISA measured 4 weeks after the booster immunisation; To establish at which day CRM -197 specific B cells are detectable in the blood of healthy children after a booster immunisation with Menjugate®, as determined by CRM -197 specific B-cell ELISpot assay or limiting dilution; Primary end point(s): To establish whether memory B cells persist in the blood at least one year after primary immunisation with Menjugate® at 2, 3 and 4 months of age as determined by meningococcal C spec | — |
Countries
United Kingdom
Outcome results
None listed