Clinical trial NCT03552445: Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine
Official title: Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine After Concomitant Vaccination in ≥50-year-old Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tetanus
Diphtheria
Pneumococcal Infections
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 462
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* Adults aged ≥50 years who signed the informed consent

Exclusion Criteria:

* history of S. pneumoniae infection within the previous 5 years
* previous pneumococcal vaccination
* previous tetanus-diphtheria (Td) vaccination within the last 10 years
* known immunodeficiency or immunosuppressant use or coagulation disorders

Primary outcomes:
measure: Tetanus antibody titers at day 28 post-vaccination
timeFrame: 4 weeks after vaccination
measure: Diphtheria antibody titers at day 28 post-vaccination
timeFrame: 4 weeks after vaccination
measure: Tetanus seroprotection rate at day 28 post-vaccination
timeFrame: 4 weeks after vaccination
measure: Diphtheria seroprotection rate at day 28 post-vaccination
timeFrame: 4 weeks after vaccination
Secondary outcomes:
measure: Opsonophagocytic assay (OPA) titers for PCV13
timeFrame: 4 weeks after vaccination
Other outcomes:
measure: Frequency and duration of local and systemic adverse events
timeFrame: During 4 weeks after vaccination
Locations:
Study officials:
References:
citation: Song JY, Cheong HJ, Noh JY, Choi MJ, Yoon JG, Lee SN, Kang SH, Jeong EJ, Jo YM, Kim WJ. Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in >/= 50-year-old adults. BMC Infect Dis. 2018 Dec 5;18(1):628. doi: 10.1186/s12879-018-3479-9.