RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

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.