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®.

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.

All randomized participants

Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.

The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.