Dataset Information

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.

SUBMITTER: Li G

PROVIDER: S-EPMC4514320 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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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.

Li Guifan G Liang Qi Q Shi Jichun J Hu Yuemei Y Li Hong H Wei Wenjin W Zhu Fengcai F Ye Qiang Q

Human vaccines & immunotherapeutics 20150101 3

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 significantl ...[more]

PMID: 25714798

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Project description: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).

Dataset Information

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.

Publications

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.

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