title: Safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine in 2 to 70 year old healthy people in China: A phase III double blind, randomized clinical trial.
abstract: To evaluate the safety and immunogenicity of 23-valent pneumococcal polysaccharide vaccine (PPV23), a randomized, double-blind and parallel controlled clinical trial was conducted in Yancheng, Jiangsu Province of China. There were 1200 subjects randomized into 2 groups with a 1:1 allocation. Subjects received 0.5 mL of tested PPV23 or control PPV23 by intramuscular injection in the deltoid, respectively. Results showed that seroconversion rates of all 23 types except type 3 were not significantly different between the 2 groups. The seroconversion rate of the Group T for type 3 (P = 0.0009) was significantly higher than the Group C. The post-vaccination GMCs of the Group T for types 1 (P = 0.0340), 3 (P = 0.0003), 9V (P = 0.0016), 11A (P = 0.0222) and 33F (P = 0.0344) were significantly higher than the Group C. The frequencies of local and general reactions were not significantly different and acceptable in both groups. In conclusion, The PPV23 showed a good immunogenicity and tolerability in 2 to 70 y old healthy people.
authors.affiliation: a Beijing Minhai Biotechnology Co. Ltd. ; Beijing, China.
authors.forename: Guifan
authors.initials: G
authors.lastname: Li
authors.forename: Qi
authors.initials: Q
authors.lastname: Liang
authors.forename: Jichun
authors.initials: J
authors.lastname: Shi
authors.forename: Yuemei
authors.initials: Y
authors.lastname: Hu
authors.forename: Hong
authors.initials: H
authors.lastname: Li
authors.forename: Wenjin
authors.initials: W
authors.lastname: Wei
authors.forename: Fengcai
authors.initials: F
authors.lastname: Zhu
authors.forename: Qiang
authors.initials: Q
authors.lastname: Ye
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000907:Antibodies, Bacterial / Q000097:blood; D002648:Child; D002675:Child, Preschool; D002681:China / Q000453:epidemiology; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D011008:Pneumococcal Infections / Q000453:epidemiology* / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D055815:Young Adult
chemical_list: C414006:23-valent pneumococcal capsular polysaccharide vaccine; D000907:Antibodies, Bacterial; D022242:Pneumococcal Vaccines
keywords: 23-valent pneumococcal polysaccharide vaccine; PPV23; clinical trial; immunogenicity; safety