Healthy subjects without known medical conditions will be vaccinated against N. meningitidis serogroup C. Active prevention of meningococcal C disease caused by Neisseria meningitidis
Conditions
Interventions
Trade Name: Menjugate
Product Name: Menjugate
Pharmaceutical Form: Powder and solvent for solution for injection
Other descriptive name: N. Meningitidis serogroup C (Strain C11) oligosaccharide conj
Sponsors
Chiron Behring GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children eligible to be enrolled in the study are those: 1. whose parents/legal guardians(s) have given written informed consent after the nature of the study has been explained 2. a. (Group E1 + E2) healthy children, who have either previously participated and completed study M14P1 and from whom at least serum samples from visit 5 and visit 6 or 7 could be evaluated, OR 2. b. (Group E3) healthy children aged 32 to 40 months who have never received any kind of meningococcal C vaccine before 3. available for the visits schedules in the study 4. in good health as determined by - medical history - clinical judgment of the investigator - pre-vaccination physical check 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: Children who are not eligible for the study are those: 1. Whose parent(s) / legal guardian(s) have not given or are unwilling to give written informed consent to their child’s participation in the study 2. With known hypersensitivity to Menjugate, any of its components or any vaccines contained within the routine immunization schedule 3. With unacceptable concurrent illnesses or conditions – i.e., children: - with severe acute or chronic illness; - who have any present or suspected serious disease such as metabolic, cardiac or autoimmune disease or insulin dependent diabetes or any other serious disease (e.g., with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease - with a genetic anomaly, e.g. Down’s syndrome - with any immunodeficiency, including those requiring use of systemic corticosteroids - who have leukemia, lymphomas or neoplasm - who have experienced significant acute or chronic infections requiring systemic antibiotic treatment or antiviral therapy within the past 14 days - who have experienced fever (defined as rectal temperature = 38.5°C) within the 3 days prior to study vaccination or are suffering from a present acute infectious disease - who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time - who have a history of seizure disorder - who have previously ascertained or suspected disease caused by N. meningitidis - with any condition that in the opinion of the investigator might interfere with the evaluation of the study objectives 4. With prohibited prior or concomitant medications: - receipt of blood, blood products or a parenteral immunoglobulin preparation - previous immunization with any non-study vaccines or investigational agents within 30 days prior to enrolment and throughout the study - receipt of immunoglobulin 5. Who have household contact with or intimate exposure to an individual with a positive culture of N. meningitidis serogroup C within the previous 60 days 6. Who previously received a meningococcal C vaccine of any kind (group E3 only) 7. Whose families are planning to leave the area of the study site permanently before the end of the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the memory antibody response to Neisseria meningitidis serogroup C after 2 doses of Menjugate® given during infancy (study group E2) is not inferior to the memory response after 3 doses of Menjugate® given during infancy (study group E1), in children now 32 to 40 months old, who participated in study M14P1 and received one dose of MenPS A/C vaccine at 12 months of age, as measured by hBCA 28 days after the third (study group E2) or fourth dose (study group E1) of Menjugate®.;Secondary Objective: 1. To determine antibody titers against Neisseria meningitidis serogroup C in naïve control subjects (32 to 40 months old, study group E3) in comparison to children primed with either 2 or 3 doses of Menjugate® during infancy, who have then received one dose of MenPS A/C vaccine, as measured by hBCA 28 days after vaccination. 2. To determine persistence of antibody response to Neisseria meningitidis serogroup C after either 2 (study group E2) or 3 doses (study group E1) of Menjugate® given during infancy and one dose of MenPS A/C vaccine given at 12 months of age in children now 32 to 40 months old, as measured by hBCA. ;Primary end point(s): To determine whether the memory antibody response to Neisseria meningitidis serogroup C after 2 doses of Menjugate® given during infancy (study group E2) is not inferior to the memory response after 3 doses of Menjugate® given during infancy (study group E1), in children now 32 to 40 months old, who participated in study M14P1 and received one dose of MenPS A/C vaccine at 12 months of age, as measured by hBCA 28 days after the third (study group E2) or fourth dose (study group E1) of Menjugate®. | — |
Countries
Germany
Outcome results
None listed