NCT03552445

Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine

Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine After Concomitant Vaccination in ≥50-year-old Adults

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 462 (actual)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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).

Conditions

• Tetanus
• Diphtheria
• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Tetanus-diphtheria (Td) and PCV13	154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0
BIOLOGICAL	PCV13 alone	154 PCV13 recipients: one vaccine injection administered on Day 0
BIOLOGICAL	Td alone	437 Td recipients: one vaccine injection administered on Day 0

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-04-30
• Completion: 2018-02-28
• First posted: 2018-06-11
• Last updated: 2018-06-11