This study evaluates 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.
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 > or 38 C 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 > or = 0.15 microg/mL for all seven serotypes and more than 95% achieved antibody levels > or = 0.50 microg/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 14-36 months.