Safety and immunogenicity of a 7-valent pneumococcal conjugate vaccine (Prevenar™): Primary dosing series in healthy Chinese infants

Summary This was a randomized safety/immunogenicity evaluation of PCV7 primary series at 3, 4, 5 months in healthy Chinese infants. Eight hundred subjects were randomized to Group 1 (PCV7 ≥7 days before DTaP), or Group 2 (PCV7 with DTaP), or Group 3 (DTaP only). Erythema and induration/swelling were recorded at the PCV7 injection site at any individual dose in no more than 12% and 8% of subjects, respectively, and neither exceeded 2.5 cm in >1% of subjects. Fever >38.0 °C was observed in > 0.35 μg/mL after dose 3, except type 6B (Group 2) with 83.3%. PCV7 had an acceptable safety profile and was immunogenic in Chinese infants.