Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)
Condition: Neisseria Meningitidis; Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Intervention: V419; PREVNAR 13®; MCC-TT; MCC-CRM; Hib-MCC; MMR Vaccine
Intervention description: Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate [meningococcal outer membrane protein complex], and Hepatitis B [recombinant] vaccine administered via 0.5 mL intramuscular injection.; Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).; Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age; Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age; Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.; Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 284.0
Sex: All
Minimum age: 46 Days
Maximum age: 74 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objectives of this study are to evaluate the immunogenicity and safety of
      concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate
      (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody
      seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B
      (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month
      post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated
      Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infant 46 to 74 days of age (both inclusive)

          -  Parent(s)/legal representative able to comply will the study procedures

        Exclusion Criteria:

          -  Is participating in a study with an investigational compound or device since birth

          -  Has a history of congenital or acquired immunodeficiency

          -  Has a history of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder

          -  Has a chronic illness that could interfere with study conduct or completion

          -  Has hypersensitivity to any of the vaccines components or history of a
             life-threatening reaction to a vaccine containing the same substances as the study
             vaccines or contraindication to any of the study vaccines

          -  Has a history, or mother has a history, of hepatitis B virus surface antigen (HBsAg)
             seropositivity

          -  Has a coagulation disorder that contraindicate intramuscular injection

          -  Has a history of vaccination with a hepatitis B, Haemophilus influenzae type b
             conjugate, diphtheria, tetanus, pertussis (acellular or whole-cell), poliovirus,
             pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate,
             measles, mumps, or rubella containing vaccine(s)

          -  Has a history of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus,
             pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles,
             mumps or rubella infection

          -  Has received immune globulin, blood or blood-derived products, immunosuppressive
             agents systemic corticosteroids since birth

          -  Has received vaccination with an inactivated (except influenza vaccine) or conjugated
             or live vaccine in the last 30 days or vaccination with an inactivated influenza
             vaccine in the last 14 days

          -  Has received antipyretic, analgesic and non-steroidal anti-inflammatory medications in
             the last 48 hours

          -  Has a febrile illness or body temperature ≥38.0°C in the last 24 hours