search
Back to results

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

Primary Purpose

Tetanus, Diphtheria, Pneumococcal Infections

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tetanus-diphtheria (Td) and PCV13
PCV13 alone
Td alone
Sponsored by
Korea University Guro Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tetanus

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Tetanus-diphtheria (Td) and PCV13

    PCV13 alone

    Td alone

    Arm Description

    Outcomes

    Primary Outcome Measures

    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
    Diphtheria antibody titers at day 28 post-vaccination
    IgG antibody titers by enzyme linked immunosorbent assay (ELISA)
    Tetanus seroprotection rate at day 28 post-vaccination
    Proportion of IgG antibody titers ≥0.1 IU/mL
    Diphtheria seroprotection rate at day 28 post-vaccination
    Proportion of IgG antibody titers ≥0.1 IU/mL

    Secondary Outcome Measures

    Opsonophagocytic assay (OPA) titers for PCV13
    Four capsule serotypes: 1, 5, 18C and 19A

    Full Information

    First Posted
    May 17, 2018
    Last Updated
    May 29, 2018
    Sponsor
    Korea University Guro Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03552445
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2013 (Actual)
    Primary Completion Date
    April 30, 2016 (Actual)
    Study Completion Date
    February 28, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Korea University Guro Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tetanus, Diphtheria, Pneumococcal Infections

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    462 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tetanus-diphtheria (Td) and PCV13
    Arm Type
    Active Comparator
    Arm Title
    PCV13 alone
    Arm Type
    Active Comparator
    Arm Title
    Td alone
    Arm Type
    Active Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    Tetanus-diphtheria (Td) and PCV13
    Intervention Description
    154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    PCV13 alone
    Intervention Description
    154 PCV13 recipients: one vaccine injection administered on Day 0
    Intervention Type
    Biological
    Intervention Name(s)
    Td alone
    Intervention Description
    437 Td recipients: one vaccine injection administered on Day 0
    Primary Outcome Measure Information:
    Title
    Tetanus antibody titers at day 28 post-vaccination
    Description
    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
    Title
    Diphtheria antibody titers at day 28 post-vaccination
    Description
    IgG antibody titers by enzyme linked immunosorbent assay (ELISA)
    Time Frame
    4 weeks after vaccination
    Title
    Tetanus seroprotection rate at day 28 post-vaccination
    Description
    Proportion of IgG antibody titers ≥0.1 IU/mL
    Time Frame
    4 weeks after vaccination
    Title
    Diphtheria seroprotection rate at day 28 post-vaccination
    Description
    Proportion of IgG antibody titers ≥0.1 IU/mL
    Time Frame
    4 weeks after vaccination
    Secondary Outcome Measure Information:
    Title
    Opsonophagocytic assay (OPA) titers for PCV13
    Description
    Four capsule serotypes: 1, 5, 18C and 19A
    Time Frame
    4 weeks after vaccination
    Other Pre-specified Outcome Measures:
    Title
    Frequency and duration of local and systemic adverse events
    Description
    The safety profiles of co-administration of Td and PCV13 will be compared to those of single vaccination.
    Time Frame
    During 4 weeks after vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30518331
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs