RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Condition: Meningitis, Meningococcal; Rotavirus Infections
MeSH terms: Rotavirus Infections; Meningitis, Meningococcal; Meningitis
Intervention: RotaTeq®; NeisVac-C®
Intervention description: Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.; Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 247.0
Sex: All
Minimum age: 42 Days
Maximum age: 55 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prevention of Gastroenteritis due to rotavirus infection. And prevention of Invasive disease caused by Neisseria meningitidis serogroup C.

Summary:

      Primary objective:

      To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine
      without impairing the efficacy of MCC vaccine. The hypothesis tested is that the
      seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant
      administration of RotaTeq® is non-inferior to that without non-concomitant (sequential)
      administration of RotaTeq®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infants, aged from 6 weeks through full 7 weeks,

          -  Consent form signed by at least one parent or by the legal representative properly
             informed about the study,

          -  Parent(s) / legal representative able to understand the protocol requirements and to
             fill in the Diary Card.

        Exclusion Criteria:

          -  History of congenital abdominal disorders, congenital malformation of the
             gastrointestinal tract that could predispose to intussusception, or abdominal surgery,

          -  Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase
             insufficiency,

          -  Known or suspected impairment of immunological function,

          -  Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C®
             (including tetanus toxoid),

          -  Prior administration of any rotavirus vaccine,

          -  Prior administration of any vaccine within the 28 days prior to randomisation,

          -  Fever (rectal temperature ≥38.1°C) and/or acute diarrhoea and/or vomiting at
             randomisation,

          -  History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to
             thrive,

          -  Any severe thrombocytopenia or any other coagulation disorder that would
             contraindicate intramuscular injection,

          -  Clinical evidence of active gastrointestinal illness,

          -  Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14
             days prior to randomisation. Note: Infants on inhaled and/or topical steroids may
             participate in the study,

          -  Infants residing in a household with an immunocompromised person,

          -  Prior receipt of a blood transfusion or blood products, including immunoglobulins.