Evaluation of the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine (Prevenar®) administered in previously unvaccinated Spanish children aged 24 to 36 months

This study evaluate the safety and immunogenicity of pneumococcal seven-valent conjugate vaccine (Prevenar®) in 115 children, aged 2–3 years (24–36 months), who have not been previously vaccinated with Prevenar®.Results:Safety: As for local reactions, 40% of children reported erythema, 32.2% induration and 39.1% tenderness at the injection site. Regarding systemic reactions, fever ≥38C was recorded in 7% of patients. Other commonly reported events were decreased appetite (24.3%), restlessness (20%), and fussiness (18.3%).Immunogenicity:After vaccination, more than 98% of the subjects achieved antibody levels of ≥0.15 μg/mL for all seven serotypes and more than 95% achieved antibody levels ≥0.50 μg/mL for all serotypes.Conclusions:Pneumococcal seven-valent conjugate vaccine (Prevenar®) was safe, well tolerated and highly immunogenic when administered in previously unvaccinated children aged 24–36 months.