A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Intervention: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate; Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined); M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live; Varicella Virus Vaccine Live; Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein); Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein); Rotavirus Vaccine; Hepatitis B Vaccine
Intervention description: 0.5 milliliter (mL), Intramuscular (IM) injection; 0.5 mL, IM injection; 0.5 mL, Subcutaneous (SC) injection; 0.5 mL, SC injection; 0.5 mL, IM injection; 0.5 mL, IM injection; oral; 0.5 mL, IM injection
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 580.0
Sex: All
Minimum age: 42 Days
Maximum age: 365 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningitis; Meningococcal Infection; Neisseria meningitidis; Tetravalent Meningococcal Vaccine

Summary:

      The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent
      Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW
      Conjugate vaccine) in order to provide an effective protein conjugate quadrivalent
      meningococcal vaccine in the population with the highest incidence of disease.

      Objectives:

        -  To describe the safety profile of MenACYW Conjugate vaccine administered at 5 different
           schedules and concomitantly with routine pediatric vaccinations.

        -  To describe the immunogenicity profile of MenACYW Conjugate vaccine administered at 5
           different schedules and concomitantly with routine pediatric vaccinations.

        -  To describe the immunogenicity profiles of selected licensed pediatric vaccines
           (Pentacel, Prevnar, M-M-RII, and Varivax) when administered either concomitantly with or
           without MenACYW Conjugate vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Groups 1, 2, 3, 6, and 7: Aged 42 to 89 days on the day of inclusion; Group 4: Aged 6
             months (180 days ± 14 days) on the day of inclusion; Group 5: Aged 12 months (365 days
             + 14 days) on the day of inclusion.

          -  Born at full term of pregnancy (greater than or equal to [≥] 37 weeks) and with a
             birth weight ≥2.5 kilogram (kg).

          -  Informed consent form had been signed and dated by the parent or other legally
             acceptable representative.

          -  Participant and parent/guardian were able to attend all scheduled visits and to be
             complied with all trial procedures.

          -  Group 4 only: Prior receipt of Pentacel and Prevnar at 2 and 4 months; 1 or 2 doses of
             rotavirus vaccine; and 2 or 3 previous doses of hepatitis B vaccine.

        Group 5 only: Prior receipt of Pentacel and Prevnar at 2, 4, and 6 months; 2 or 3 doses of
        rotavirus vaccine; and 3 previous doses of hepatitis B vaccine.

        Exclusion Criteria:

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or medical procedure in the 4 weeks preceding the first trial vaccination.

          -  Planned participation in another clinical trial during the present trial period.

          -  Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.

          -  Planned receipt of any vaccine in the 4 weeks following any trial vaccination, with
             the exception of influenza vaccine, which may be received 14 days before or after
             MenACYW Conjugate vaccine.

          -  Previous vaccination against meningococcal disease with either the trial vaccine or
             another vaccine.

          -  Receipt of blood or blood-derived products in the past 30 days, which might interfere
             with assessment of the immune response.

          -  Known or suspected congenital or acquired immunodeficiency; 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).

          -  Known personal or maternal seropositivity for human immunodeficiency virus (HIV),
             hepatitis B vaccine, or hepatitis C, as reported by the parent/guardian.

          -  History of meningococcal infection, confirmed either clinically, serologically, or
             microbiologically.

          -  At high risk for meningococcal infection during the trial.

          -  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.

          -  Thrombocytopenia, as reported by the parent/guardian.

          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
             contraindicating intramuscular vaccination.

          -  History of seizures.

          -  Personal or family history of Guillain-Barré Syndrome (GBS).

          -  Chronic illness that, in the opinion of the investigator, was at a stage where it
             might interfere with trial conduct or completion.

        Temporary contraindications were resolved before vaccination:

          -  Febrile illness (temperature ≥38.0 degree Celsius [≥100.4 degree Fahrenheit]) or
             moderate or severe acute illness/infection (according to investigator judgment) on the
             day of vaccination.

          -  Group 5 only: Receipt of oral or injected antibiotic therapy within the 72 hours prior
             to the study blood draw. Topical antibiotics or antibiotic drops were not included in
             this exclusion criterion. (Note: This did not applied to the other groups at this
             time, as they did not have a blood draw within 30 days of the initial visit.).