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.

摘要: Introduction The invasive pneumococcal diseases (IPDs) caused by Streptococcus pneumoniae pose an enormous threat to children under 5 years of age. However, routine use conjugate vaccines could aid in reducing the incidence IPDs. purpose this clinical trial is assess non-inferiority investigational 13-valent vaccine (PCV13) currently licensed 7-valent (PCV7). Methods and analysis 1040 infants will receive a three-dose series either PCV13 or PCV7 at ages 3, 4 5 months, respectively, booster dose 12–15 months. Primary end points are percentage participants reaching serotype-specific IgG concentration ≥0.35 µg/mL antibody geometric mean concentrations (GMCs) measured 30 days after primary immunisation. Secondary include recipients threshold 1.0 µg/mL, opsonophagocytic assay (OPA) titre 1:8, titres (GMTs) OPA doses. number standard responders GMCs immunisation also be determined. To evaluate differences between two groups, sequential testing for seven common serotypes its effectiveness treating six additional performed. Ethics dissemination approvals have been granted Committees three provinces involved study: Shanxi, Henan Hebei. reported accordance with CONSORT guidance. Trial registration NCT02736240.