title: Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China.
abstract: The invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae pose an enormous threat to children under 5 years of age. However, routine use of pneumococcal conjugate vaccines could aid in reducing the incidence of IPDs. The purpose of this clinical trial is to assess the non-inferiority of the investigational 13-valent pneumococcal conjugate vaccine (PCV13) to the currently licensed 7-valent pneumococcal conjugate vaccine (PCV7).
  
  
  
  1040 infants will receive a three-dose series of either PCV13 or PCV7 at ages 3, 4 and 5 months, respectively, and a booster dose at 12-15 months. Primary end points are the percentage of participants reaching a serotype-specific IgG concentration of ≥0.35 µg/mL and the IgG antibody geometric mean concentrations (GMCs) measured 30 days after the primary immunisation. Secondary end points include the percentage of vaccine recipients reaching a serotype-specific IgG concentration threshold of 1.0 µg/mL, the percentage of participants reaching the pneumococcal opsonophagocytic assay (OPA) titre threshold of 1:8, and the geometric mean titres (GMTs) of OPA measured 30 days after primary and booster doses. The number of standard IgG responders and IgG GMCs measured 30 days after the booster immunisation will also be determined. To evaluate differences between two groups, the sequential testing of the non-inferiority of PCV13 for the seven common serotypes and its effectiveness in treating the six additional serotypes will be performed.
  
  
  
  Ethics approvals have been granted by the Ethics Committees at the three provinces involved in this study: Shanxi, Henan and Hebei. The trial will be reported in accordance with the CONSORT guidance.
  
  
  
  NCT02736240.
authors: Department of Health Statistics of Fourth Military Medical University, Xi'an, China.|Walvax, Walvax Biotechnology Co., Ltd., Kunming, China.
authors: Jing Jing
authors: JJ
authors: Chen
authors: Walvax, Walvax Biotechnology Co., Ltd., Kunming, China.
authors: Lin
authors: L
authors: Yuan
authors: Walvax, Walvax Biotechnology Co., Ltd., Kunming, China.
authors: Zhen
authors: Z
authors: Huang
authors: Beijing Chaoyang District Centre for Disease Control and Prevention, Beijing, China.
authors: Nian Min
authors: NM
authors: Shi
authors: Heibei Province Centre for Disease Control and Prevention, Shijiazhuang, China.
authors: Yu Liang
authors: YL
authors: Zhao
authors: Henan Province Centre for Disease Control and Prevention, Zhengzhou, China.
authors: Sheng Li
authors: SL
authors: Xia
authors: Shanxi Province Centre for Disease Control and Prevention, Taiyuan, China.
authors: Guo Hua
authors: GH
authors: Li
authors: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, China.
authors: Rong Cheng
authors: RC
authors: Li
authors: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning, China.
authors: Yan Ping
authors: YP
authors: Li
authors: Walvax, Walvax Biotechnology Co., Ltd., Kunming, China.
authors: Shu Yuan
authors: SY
authors: Yang
authors: Department of Health Statistics of Fourth Military Medical University, Xi'an, China.
authors: Jie Lai
authors: JL
authors: Xia
mesh_terms: D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D002681:China / Q000453:epidemiology; D000069443:Heptavalent Pneumococcal Conjugate Vaccine / Q000008:administration & dosage; D007115:Immunization Schedule; D000071497:Immunogenicity, Vaccine / Q000276:immunology; D011008:Pneumococcal Infections / Q000276:immunology / Q000517:prevention & control; D022242:Pneumococcal Vaccines / Q000008:administration & dosage; D012449:Safety; D013296:Streptococcus pneumoniae / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage; D018074:Vaccines, Conjugate / Q000008:administration & dosage; D000074099:Equivalence Trials as Topic
chemical_list: C538862:13-valent pneumococcal vaccine; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; D022242:Pneumococcal Vaccines; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate
keywords: Non-inferiority; Pneumococcal conjugate vaccine; Sequential test