Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W) MedDRA version: 18.0 Level: PT Classification code 10058858 Term: Meningococcal bacteraemia System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0 Level: PT Classification code 10027274 Term: Meningococcal infection System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
Sanofi Pasteur
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: An individual must fulfill all of the following criteria in order to be eligible for trial enrollment: 1) Aged 12 to 23 months on the day of the first study visit 2) Born at full term of pregnancy (= 37 weeks) or with a birth weight = 2.5 kg (5.5 pounds) 3) Informed consent form (ICF) has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations) 4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures 5) Covered by health insurance where applicable Are the trial subjects under 18? yes Number of subjects for this age range: 200 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: An individual fulfilling any of the following criteria is to be excluded from trial enrollment: 1) Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure 2) Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine before the final blood draw except for influenza vaccination, which may be received at least 2 weeks before or after the study vaccines 3) Previous vaccination against meningococcal disease with either the trial vaccine or mono-, or polyvalent polysaccharide or conjugate meningococcal vaccine containing serogroups A, B, C, W, or Y 4) Receipt of immune globulins, blood, or blood-derived products in the past 3 months 5) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (= 2mg/kg/day of prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) 6) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically 7) At high risk for meningococcal infection during the trial (i.e., subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease) 8) Known systemic hypersensitivity to any of the vaccine components, history of a life-threatening reaction to the vaccines used in the trial, or to a vaccine containing any of the same substances 9) Known systemic hypersensitivity to latex 10) Known thrombocytopenia, as reported by the parent/legally acceptable representative 11) Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination 12) Personal history of Guillain-Barré syndrome (GBS) 13) Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine 14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion 15) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. 16) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. 17) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: E.2.1 Observational objectives: •To evaluate the antibody responses to the antigens (serogroups A, C, Y, and W) present in MenACYW conjugate vaccine and NIMENRIX® measured by serum bactericidal assay using baby rabbit complement (rSBA) and by serum bactericidal assay using human complement (hSBA) •To evaluate the antibody responses against tetanus in subjects who received MenACYW conjugate vaccine or NIMENRIX vaccine •To evaluate the safety profile of MenACYW conjugate vaccine and NIMENRIX® ;Secondary Objective: Not applicable;Primary end point(s): Immunogenicity The following serological endpoints will be assessed immediately before and 30 days after vaccination: • Antibody titers against meningococcal serogroups A, C, Y, and W measured by rSBA and hSBA for Group 1 and Group 2. • Tetanus toxoid is contained in both the investigational and control vaccines as a carrier protein. Therefore, blood samples will also be tested for anti-tetanus antibodies by enzyme-linked immunosorbent assay (ELISA). The following parameters will be assessed: • At both pre- and post-vaccination time point, geometric mean concentrations (GMCs) • At both pre- and post-vaccination time points, the proportion of subjects achieving seroprotective levels = 0.01 IU/milliliters (mL) and = 0.1 IU/mL of antibody concentrations to tetanus toxoid Safety • Occurrence, nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), duration, intensity, and relationship to vaccination of any unsolicited systemic adverse events (AEs) reported in the 30 minutes after vaccination. • Occurrence, time to onset, number of days of occurrence, intensity, action taken, and whether the reaction led to early termination from the study, of solicited (prelisted in the subject’s diary card and electronic Case Report form [CRF]) injection site reactions occurring up to 7 days after vaccination. • Occurrence, time to onset, number of days of occurrence, intensity, action taken, and wheth | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Finland
Contacts
Public ContactSenior Director, Clinical Developme
Sanofi Pasteur
Outcome results
None listed