Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)
Condition: Neisseria Meningitidis; Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Intervention: PR5I; Pediacel®; NeisVac-C®; RotaTeq®; Prevenar 13®
Intervention description: Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Hepatitis B [HB; Recombinant DNA], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age.; Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age.; Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.; Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying.; Pneumococcal polysaccharide conjugate vaccine [PCV; 13-valent, adsorbed]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 385.0
Sex: All
Minimum age: 46 Days
Maximum age: 76 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the immune response and the safety of a primary series schedule that includes
      V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age

      Primary objectives

        -  To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (HB)
           one month after completion of the mixed schedule

        -  To demonstrate that the mixed schedule induces acceptable responses for Haemophilus
           influenzae type b (Hib) one month after completion of the mixed schedule

      Secondary objectives

        -  To describe the antibody response to all PR5I antigens one month after completion of the
           mixed schedule

        -  To describe the antibody response to meningococcal serogroup C (MCC) conjugate vaccine
           one month after the second dose of MenC vaccine

        -  To describe the safety profile after each dose of study vaccines administered
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infant 46 to 74 days (both inclusive)

          -  Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3
             days after birth

          -  Parent(s)/legal representative able to comply with the study procedures

        Exclusion Criteria:

          -  Participation in any study with an investigational compound or device since birth

          -  History of congenital or acquired immunodeficiency

          -  Chronic illness that could interfere with study conduct or completion

          -  Hypersensitivity to any of the study vaccines components or history of a
             life-threatening reaction to a vaccine containing the same substances as the study
             vaccines

          -  Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®

          -  History or maternal history of HBsAg seropositivity

          -  Coagulation disorder that contraindicate intramuscular injection

          -  History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria,
             tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C
             conjugate, pneumococcal conjugate containing vaccine(s)

          -  History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis,
             poliomyelitis, or serogroup C meningococcal infection

          -  Receipt of immune globulin, blood or blood-derived products since birth

          -  Receipt of systemic corticosteroids for more than 14 consecutive days within one month
             of the study start

          -  Identified as a natural or adopted child of the Investigator or employee with direct
             involvement in the proposed study