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Streptococcus pneumoniae is a major disease burden in young children and the incidence of antibiotic-resistant pneumococcal strains is increasing. Multivalent pneumococcal saccharide-protein conjugate vaccines have recently been developed.To assess the immunogenicity and reactogenicity of a 7-valent pneumococcal conjugate vaccine (7VPnC) administered as a separate injection or as a combined injection with Haemophilus influenzae type b vaccine (HbOC) at 2, 3 and 4 months of age.Randomized controlled trial of 368 healthy UK infants receiving routine vaccines only (control group), routine vaccines and 7VPnC as a separate injection (separate group), or routine vaccines and 7VPnC combined with HbOC (combined group) at 2, 3 and 4 months. The control group received 7VPnC at 5, 6 and 7 months. All groups received pneumococcal polysaccharide vaccine at 13 to 16 months. Anticapsular IgG antibodies to 7VPnC serotypes were measured at 2, 5, 13 and 14 months and safety data collected.IgG antibody concentrations at 5 months were higher in the two treatment groups compared with the controls for all 7VPnC serotypes (P < 0.001) and higher in the separate group than the combined group for five 7VPnC serotypes (P < 0.05). For both treatment groups antibody concentrations were higher at 14 months (range, 6.6 to 25.3 μg/ml) than at 5 months (range, 0.6 to 2.5 μg/ml) for all 7VPnC serotypes (P < 0.001).7VPnC was well-tolerated, safe and immunogenic when administered as a separate or as a combined 7VPnC/HbOC injection. Although antibody responses were lower in the infants who received the combination compared with those who received 7VPnC as a separate injection, marked anamnestic responses to polysaccharide challenge were observed, suggesting that both groups were immunologically primed.