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

Brief Title

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

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).
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Tetanus antibody titers at day 28 post-vaccination

Secondary Outcome

 Opsonophagocytic assay (OPA) titers for PCV13

Condition

Tetanus

Intervention

Tetanus-diphtheria (Td) and PCV13

Study Arms / Comparison Groups

 Tetanus-diphtheria (Td) and PCV13
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

462

Start Date

November 1, 2013

Completion Date

February 28, 2018

Primary Completion Date

April 30, 2016

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
      

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Administrative Informations


NCT ID

NCT03552445

Organization ID

2013GR0005


Responsible Party

Principal Investigator

Study Sponsor

Korea University Guro Hospital


Study Sponsor

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Verification Date

May 2018