Safety and immunogenicity of a 7-valent pneumococcal conjugate vaccine (Prevenar): primary dosing series in healthy Chinese infants.
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.
Li
Rong Cheng
RC
Guangxi Center for Disease Control and Prevention, #18 Jin Zhou Road, Nanning 530028, Guangxi, PR China. lrch2001@163.com
Li
Feng Xiang
FX
Li
Yan Ping
YP
Guo
Su Ying
SY
Nong
Yi
Y
Ye
Qiang
Q
Fang
Kong Xiong
KX
Wei
Shao Chao
SC
Wang
Zhiqian
Z
Lockhart
Stephen
S
D000907:Antibodies, Bacterial / Q000097:blood; D044466:Asian People; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage*; D004890:Erythema; D005260:Female; D005334:Fever; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D013997:Time Factors
D000907:Antibodies, Bacterial; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D007074:Immunoglobulin G; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines