title: Immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in Chinese healthy population aged >2 years: A randomized, double-blinded, active control, phase III trial.
abstract: Streptococcus pneumoniae is an important pathogen causing invasive diseases such as sepsis, meningitis, and pneumonia. Vaccines have become the most effective way to prevent pneumococcal infections. This phase III trial was designed to evaluate the immunogenicity and safety of a 23-valent pneumococcal polysaccharide vaccine in Chinese healthy population aged >2 years. We conducted a randomized, double-blinded, active-controlled, multicenter trial in which 1660 healthy population (>2 years of age) were randomly assigned in a 1 : 1 ratio to receive 2 intramuscular doses of either the treatment vaccine or the active control vaccine, PNEUMOVAX 23. The surveillance period was 30 days. The primary end point was the 2-fold increase rate of anti-pneumococcal antibody for all 23 included serotypes in each group. In the intention-to-treat cohort, the 2-fold increase rate of anti-pneumococcal antibody for 23 included serotypes varied from 62.47% to 97.01% in the treatment group, and from 51.49% to 95.77% in the control group. According to -10% non-inferiority margin and 95% confidence intervals of rate difference, almost all included serotypes of the treatment group reached non-inferiority to control group except for serotype 6B, the lower limit of rate difference of which was -10.00%, equal to the non-inferiority margin. The 2-fold increase rates of anti-pneumococcal antibody were significantly higher in the treatment group for serotype 2, 3, 4, 10A, 11A and 20. Furthermore, for all 23 serotypes, IgG geometric mean concentrations (GMCs) at day 30 were significantly higher in treatment group for serotype 2, 3, 4, 9 V, 10A, 11A, 15 B, 18C, 19 A, 22 F and 33 F. Higher geometric mean fold increase (GMFI) were also observed in the treatment group correspondingly. Serious adverse events occurred in 3 of 830 participants in the treatment group (0.36%) and 2 of 830 participants in the control group (0.24%). No death occurred during the trial. The frequencies of both solicited and unsolicited adverse events (AEs) were small lower in the treatment group (34.34% vs 35.66% for solicited AEs, 4.34% vs 5.42% for unsolicited AEs). Both vaccines were well tolerated and most AEs were mild or moderate in intensity. The newly vaccine was well tolerated and immunologically non-inferior to the active control vaccine PNEUMOVAX 23 for all 23 vaccine serotypes in the Chinese population (>2 years of age).
authors.affiliation: a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China.
authors.forename: Yujia
authors.initials: Y
authors.lastname: Kong
authors.affiliation: a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.affiliation: a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China.
authors.forename: Zhiwei
authors.initials: Z
authors.lastname: Jiang
authors.affiliation: a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China.
authors.forename: Ling
authors.initials: L
authors.lastname: Wang
authors.affiliation: a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China.
authors.forename: Chanjuan
authors.initials: C
authors.lastname: Li
authors.affiliation: b Center for Disease Control and Prevention of the Guangxi Zhuang Autonomous Region ; Nanning , China.
authors.forename: Yanping
authors.initials: Y
authors.lastname: Li
authors.affiliation: a Department of Health Statistics ; School of Preventive Medicine; Fourth Military Medical University ; Xi'an , Shaanxi , China.
authors.forename: Jielai
authors.initials: J
authors.lastname: Xia
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000907:Antibodies, Bacterial / Q000097:blood*; D044466:Asian People; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D013290:Streptococcal Infections / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C414006:23-valent pneumococcal capsular polysaccharide vaccine; D000907:Antibodies, Bacterial; D022242:Pneumococcal Vaccines
keywords: immunogenicity; pneumococcal polysaccharide vaccine; safety