Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination
Condition: Neisseria Meningitidis; Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Series Primary objectives

        -  To demonstrate that the concomitant administration of the hexavalent vaccine with a
           meningococcal serogroup C conjugate vaccine is non inferior to the administration of the
           hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate
           for hepatitis B one month after the third dose of the hexavalent vaccine

        -  To demonstrate that the concomitant administration of a MenC vaccine with the hexavalent
           vaccine induces an acceptable response for MenC in term of seroprotection rate (SPR) one
           month after the second dose of MenC

      Booster Primary objectives

      - To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a
      meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months of
      age or given separately.
    

Detailed description: 
      Primary Series Secondary objectives

        -  To describe the antibody response to all the hexavalent vaccine antigens one month after
           the third dose of the hexavalent vaccine when given concomitantly or not to MenC

        -  To describe the antibody response to MenC vaccine when a MenC vaccine is given
           concomitantly with the hexavalent vaccine, one month after the first and the second dose
           of MenC vaccine

        -  To describe the safety profile of the hexavalent vaccine after each and any injection
           when given concomitantly or not with a MenC vaccine

      Booster Secondary objectives

        -  To describe the antibody (Ab) persistence at 12 months of age for the hexavalent
           valences following a 3-dose primary vaccination at 2, 3 and 4 months of age (prior to
           administration of a booster dose)

        -  To describe the safety of a booster dose of the hexavalent vaccine and of a
           meningococcal group ACWY conjugate (MenACWY) vaccine either co-administered at 12 months
           of age or given separately.
    

Intervention name(s): Hexavalent vaccine; NeisVac-C; Prevenar 13; RotaTeq; Nimenrix; M-M-RVAXPRO
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster); 0.5 mL intramuscular injection at 2 and 4 months of age; 0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster); 2 mL oral administration at 2, 3 and 4 months; 0.5 mL intramuscular injection at 12 months; 0.5 mL intramuscular or subcutaneous injection at 13 months of age
Other intervention name(s): Diphtheria, tetanus, pertussis, hepatitis B,; poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed).; Meningococcal group C polysaccharide conjugate vaccine adsorbed; Pneumococcal conjugate vaccine (13-valent, adsorbed); Human-bovine rotavirus reassortants (live) vaccine; Meningococcal group A, C, W-135 and Y conjugate vaccine; Measles, mumps and rubella vaccine (live)
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention