Immunogenicity and Safety of a Booster Dose of a Quadrivalent Meningococcal Conjugate Vaccine in Children
Condition: Meningococcal Infections
MeSH terms: Meningococcal Infections
Intervention: MenACYW conjugate vaccine
Intervention description: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 46 Months
Maximum age: 61 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal Meningitis; MenACYW conjugate vaccine; Quadrivalent meningococcal vaccine

Summary:

      This was an open-label, multi-center study to describe the immune persistence of the priming
      dose and describe the immunogenicity and safety of a booster dose of Meningococcal
      Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine in
      children in Finland who had been vaccinated 3 years earlier as toddlers with either MenACYW
      conjugate vaccine or Nimenrix® as part of the MET54 study (NCT03205358).

      The objectives were:

        -  To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a
           booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3
           years earlier as toddlers.

        -  To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days
           after a booster dose of MenACYW conjugate vaccine in children who received either
           MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.

        -  To describe the antibody responses against tetanus toxoid 30 days after a booster dose
           of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine
           or Nimenrix® 3 years earlier as toddlers.

        -  To describe the safety profile of a booster dose of MenACYW conjugate vaccine in
           children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as
           toddlers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participated in and completed (attended Visit 2) study MET54.

          -  Informed consent form had been signed and dated by the parent(s) or another 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 complied with all trial procedures.

          -  Covered by health insurance where applicable.

        Exclusion Criteria:

          -  Participation 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.

          -  Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or
             planned receipt of any vaccine prior to Visit 2 except for influenza vaccination,
             which might be received at a gap of at least 2 weeks before or after the study
             vaccines. This exception includes monovalent pandemic influenza vaccines and
             multivalent influenza vaccines. If the participant was due to receive vaccination(s)
             recommended for his/her age by the national immunization schedule at the time of the
             study, the participant was recommended to complete his/her immunization schedule after
             Visit 2.

          -  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 vaccine) with the
             exception of the single dose of meningococcal vaccine administered as part of study
             MET54.

          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months.

          -  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
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).

          -  History of meningococcal infection, confirmed either clinically, serologically, or
             microbiologically

          -  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 traveling to countries with high endemic or
             epidemic disease).

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine used in the trial or to a vaccine containing
             any of the same substances.

          -  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.

          -  Personal history of Guillain-Barré syndrome.

          -  Personal history of an Arthus-like reaction after vaccination with a tetanus
             toxoid-containing vaccine.

          -  Chronic illness that, in the opinion of the Investigator, was at a stage where it
             might interfere with trial conduct or completion.

          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the
             day of vaccination or febrile illness (temperature >= 38.0 degree Celsius [°C]). A
             prospective participant was not included in the study until the condition had resolved
             or the febrile event had subsided.

          -  Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first
             blood draw.

          -  Identified as a natural or adopted child of the Investigator or employee with direct
             involvement in the proposed study.