Active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W). MedDRA version: 20.0 Level: PT Classification code 10027274 Term: Meningococcal infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: MenACYW Conjugate Vaccine
Product Code: 395
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Neisseria Meningitidis Serogroup A Polysachharide Conjugated to Tetanus Toxoi
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 study enrollment: 1) Aged = 56 to = 89 days on the day of the first study visit 2) Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg (or 5 lb and 8 oz) 3) Informed consent form 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 Are the trial subjects under 18? yes Number of subjects for this age range: 700 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 study enrollment: 1) Participation at the time of study enrollment (or in the 4 weeks preceding the first 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 first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines 3) Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine) 4) Previous vaccination with any pneumococcal, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), poliovirus, and/or rotavirus vaccines. Receipt of BCG vaccine at birth is acceptable 5) Receipt of immune globulins, blood or blood-derived since birth 6) Known or suspected congenital or acquired immunodeficiency, including Severe Combined Immunodeficiency disorder (SCID); or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth 7) History of any neurologic disorders, including any seizures and progressive neurologic disorders or encephalopathy 8) History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically 9) History of diphtheria, tetanus, pertussis, poliomyelitis, Hib, hepatitis B, Streptococcus pneumoniae, and/or rotavirus infection or disease 10) At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects travelling to countries with high endemic or epidemic disease) 11) History of Guillain-Barré syndrome 12) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances including neomycin, kanamycin, polymyxin, formaldehyde, and latex 13) Hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency 14) History of intussusception or uncorrected congenital malformation of the gastrointestinal tract that would predispose to intussusception 15) Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the investigator’s opinion 16) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination 17) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion 18) Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, including planning to leave the area of the study site before the end of the study 19) Moderate or severe acute illness/infection (according
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine is administered concomitantly with Bexsero® in the second year of life compared to when MenACYW conjugate vaccine is given alone.;Secondary Objective: To describe the antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine is administered concomitantly with Bexsero® in the second year of life and when MenACYW conjugate vaccine is given alone ;Primary end point(s): Antibody titers = 1:8 against meningococcal serogroups A, C, Y, and W measured by hSBA assessed 30 days after vaccination(s) at 12 to 13 months of age (Group 1 versus Group 2);Timepoint(s) of evaluation of this end point: 30 days after vaccination at 12 to 13 months of age | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): GMTs against meningococcal serogroups A, C, Y, and W measured by hSBA at baseline (pre-vaccination) and 30 days after vaccinations at 12 to 13 months of age (Group 1 versus Group 2).;Timepoint(s) of evaluation of this end point: 30 days after vaccination at 12 to 13 months of age | — |
Countries
United Kingdom
Contacts
Public ContactClinical Team Leader
Sanofi Pasteur
Outcome results
None listed