Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine in Infants and Toddlers When Administered Concomitantly With Routine Pediatric Vaccines in the United Kingdom
Condition: Healthy Volunteers (Meningococcal Infection)
MeSH terms: Meningococcal Infections
Intervention: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine; Meningococcal group B vaccine; Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine; Human rotavirus RIX4414 strain vaccine; Pneumococcal 13-valent polysaccharide conjugate vaccine
Intervention description: Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL; Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL; Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL; Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL; Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 788.0
Sex: All
Minimum age: 56 Days
Maximum age: 89 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the study was to demonstrate the non-inferiority of the antibody
      responses to meningococcal serogroups A, C, W, and Y (MenACYW) in terms of serum bactericidal
      assay using human complement (hSBA) vaccine seroprotection (antibody titer greater than or
      equal to [>=] 1:8) when MenACYW Conjugate vaccine was administered concomitantly with
      Bexsero® in the second year of life compared to when MenACYW Conjugate vaccine was given
      alone.

      The secondary objectives were to compare the hSBA antibody response in terms of geometric
      mean titers (GMTs) against meningococcal serogroups A, C, W, and Y when MenACYW Conjugate
      vaccine was administered concomitantly with Bexsero® or when MenACYW Conjugate vaccine was
      given alone in the second year of life; to describe the hSBA and serum bactericidal assay
      using baby rabbit complement (rSBA) antibody responses against meningococcal serogroups A, C,
      W, and Y before and after the 1st dose of MenACYW Conjugate vaccine administered at 3 months
      of age, before and after the 2nd dose of MenACYW Conjugate vaccine administered at 12 to 13
      months of age for Group 1 and Group 2; to describe the hSBA and rSBA antibody persistence
      against meningococcal serogroups A, C, W, and Y after the 1st dose of MenACYW Conjugate
      vaccine administered at 3 months of age for Group 1 and Group 2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged >= 56 to less than or equal to (<=) 89 days on the day of the first study visit.

          -  Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kilogram
             (kg) (or 5 lb and 8 oz).

          -  Informed consent form had been signed and dated by the parent(s) or other legally
             acceptable representative (and by an independent witness if required by local
             regulations).

          -  Participant and parent/legally acceptable representative were able to attend all
             scheduled visits and to comply with all trial procedures.

        Exclusion Criteria:

        -- 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.

          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (at Visit
             1) 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.

          -  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, W, or Y; or meningococcal B serogroup-containing
             vaccine).

          -  Previous vaccination (before Visit 1) with any pneumococcal, diphtheria, tetanus,
             pertussis, hepatitis B, Haemophilus influenzae type b (Hib), poliovirus, and/or
             rotavirus vaccines. Receipt of BCG vaccine at birth was acceptable.

          -  Receipt of immune globulins, blood or blood-derived since birth.

          -  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.

          -  History of any neurologic disorders, including any seizures and progressive neurologic
             disorders or encephalopathy.

          -  History of Neisseria meningitidis infection, confirmed either clinically,
             serologically, or microbiologically.

          -  History of diphtheria, tetanus, pertussis, poliomyelitis, Hib, hepatitis B,
             Streptococcus pneumoniae, and/or rotavirus infection or disease.

          -  At high risk for meningococcal infection during the trial (specifically, but not
             limited to, participants with persistent complement deficiency, with anatomic or
             functional asplenia, or participants travelling to countries with high endemic or
             epidemic disease).

          -  History of Guillain-Barré syndrome.

          -  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.

          -  Hereditary problems of fructose intolerance, glucose-galactose malabsorption or
             sucrase-isomaltase insufficiency.

          -  History of intussusception or uncorrected congenital malformation of the
             gastrointestinal tract that would predispose to intussusception.

          -  Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the
             investigator's opinion.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination.

          -  Chronic illness that, in the opinion of the investigator, was at a stage where it
             might interfere with trial conduct or completion.

          -  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.

          -  Moderate or severe acute illness/infection (according to investigator judgment), or
             febrile illness (temperature >= 38.0°C), or diarrhea or vomiting on the day of
             vaccination. A prospective participant should not be included in the study until the
             condition had resolved or the febrile event has subsided.

          -  Identified as a natural or adopted child of the Investigator or employee with direct
             involvement in the proposed study.