When two or more vaccines are administered concurrently, there is a concern on vaccine interaction, which can either enhance or suppress immune response to vaccine antigens. This study is designed to evaluate the immunogenicity and safety of tetanus-diphtheria (Td) and pneumococcal vaccines after concomitant administration in adults aged 50 years and older.
Vaccination would be the most effective strategy to prevent diverse infectious diseases. Actually, The World Health Organization (WHO) estimate that vaccination averts 2-3 million deaths per year. In adults, several vaccines are recommended based on age and medical conditions if they have not receive vaccination before, and lack evidence of past infection: influenza, measles-mumps-rubella (MMR), varicella, human papilloma virus (HPV), tetanus-diphtheria (Td), pneumococcl vaccines and etc. In particular, when the patient visits a vaccination clinic, Td and the pneumococcal vaccines are commonly administered at the same time. In this study, we aimed to evaluate the immunogenicity and safety of Td vaccine and PCV13 after concomitant administration in adults aged 50 years. This single-center, open label randomized trial was conducted (Clinical Trial Number - NCT02215863) at Korea University Guro Hospital from November 2013 to April 2016. Adults ≥50 years of age were randomized in a 1:1:1 ratio to receive Td + PCV13 (Group 1), PCV13 alone (Group 2) or Td alone (Group 3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
462
154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0
154 PCV13 recipients: one vaccine injection administered on Day 0
437 Td recipients: one vaccine injection administered on Day 0
Tetanus antibody titers at day 28 post-vaccination
IgG antibody titers by enzyme linked immunosorbent assay (ELISA) Seroprotection rate: percentage of subjects with a post-vaccination antibody levels ≥0.1 IU/mL
Time frame: 4 weeks after vaccination
Diphtheria antibody titers at day 28 post-vaccination
IgG antibody titers by enzyme linked immunosorbent assay (ELISA)
Time frame: 4 weeks after vaccination
Tetanus seroprotection rate at day 28 post-vaccination
Proportion of IgG antibody titers ≥0.1 IU/mL
Time frame: 4 weeks after vaccination
Diphtheria seroprotection rate at day 28 post-vaccination
Proportion of IgG antibody titers ≥0.1 IU/mL
Time frame: 4 weeks after vaccination
Opsonophagocytic assay (OPA) titers for PCV13
Four capsule serotypes: 1, 5, 18C and 19A
Time frame: 4 weeks after vaccination
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