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

Research paper by Rong Cheng RC Li, Feng Xiang FX Li, Yan Ping YP Li, Su Ying SY Guo, Yi Y Nong, Qiang Q Ye, Kong Xiong KX Fang, Shao Chao SC Wei, Zhiqian Z Wang, Stephen S Lockhart

Indexed on: 01 Apr '08Published on: 01 Apr '08Published in: Vaccine



Abstract

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 > or =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 degrees C was observed in <13% of subjects at any individual dose. For each vaccine serotype, at least 90% of subjects (Groups 1 and 2) had IgG concentrations > or = 0.35 microg/mL after dose 3, except type 6B (Group 2) with 83.3%. PCV7 had an acceptable safety profile and was immunogenic in Chinese infants.

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