This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate vaccine (Synflorix vaccine, or GSK1024850A) to prevent cases of pneumonia (lung infection) likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of otitis media (ear infection) in children under 3 years old.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The following vaccines will be offered by the sponsor: * Two doses of hepatitis A vaccine will be offered to all subjects to comply with national recommendations. * NeisVac-C vaccine against Neisseria meningitis group C will be offered to all subjects in Argentina at 12 months of age. * Varicella vaccine will be offered to all subjects in Colombia and Panama at 12 months of age. * Two doses of Rotarix vaccine will be offered to all subjects in Colombia within the first six months of life. In addition, all subjects will receive a dose of Hepatitis B vaccine at birth according to national recommendations and a dose of measles, mumps and rubella (MMR) vaccine at 12 to 15 months of age according to local Extended Program of Immunization (EPI) . These vaccines will not be provided by the sponsor. The protocol posting has been updated according to the amendment of the protocol dated 25 Nov 2008. The protocol posting has been updated according to the amendment of the protocol dated 14 December 2009. The protocol posting has been updated according to the amendment of the protocol dated 09 September 2010.
Intramuscular injection, 4 doses
Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group
Intramuscular injection, 3 doses
Intramuscular injection,3 doses
Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group
Godoy Cruz, Mendoza Province, Argentina
Las Heras, Mendoza Province, Argentina
Luján de Cuyo, Mendoza Province, Argentina
Villa Nueva, Mendoza Province, Argentina
Villanueva, Mendoza Province, Argentina
Albardón, San Juan Province, Argentina
Caucete, San Juan Province, Argentina
Fernández, Santiago del Estero Province, Argentina
La Banda, Santiago del Estero Province, Argentina
Córdoba, Argentina
La Banda, Argentina
Maipú, Argentina
Mendoza, Argentina
San Juan, Argentina
San Juan, Argentina
San Juan, Argentina
San Martín, Argentina
Santiago del Estero, Argentina
Santiago del Estero, Argentina
Santiago del Estero, Argentina