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

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ClinicalTrials.gov Identifier: NCT03552445
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Joon Young Song, Korea University Guro Hospital

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.

Condition or disease Intervention/treatment Phase
Tetanus Diphtheria Pneumococcal Infections Biological: Tetanus-diphtheria (Td) and PCV13 Biological: PCV13 alone Biological: Td alone Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 1, 2013
Actual Primary Completion Date : April 30, 2016
Actual Study Completion Date : February 28, 2018


Arm Intervention/treatment
Active Comparator: Tetanus-diphtheria (Td) and PCV13 Biological: Tetanus-diphtheria (Td) and PCV13
154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0

Active Comparator: PCV13 alone Biological: PCV13 alone
154 PCV13 recipients: one vaccine injection administered on Day 0

Active Comparator: Td alone Biological: Td alone
437 Td recipients: one vaccine injection administered on Day 0




Primary Outcome Measures :
  1. Tetanus antibody titers at day 28 post-vaccination [ Time Frame: 4 weeks after 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

  2. Diphtheria antibody titers at day 28 post-vaccination [ Time Frame: 4 weeks after vaccination ]
    IgG antibody titers by enzyme linked immunosorbent assay (ELISA)

  3. Tetanus seroprotection rate at day 28 post-vaccination [ Time Frame: 4 weeks after vaccination ]
    Proportion of IgG antibody titers ≥0.1 IU/mL

  4. Diphtheria seroprotection rate at day 28 post-vaccination [ Time Frame: 4 weeks after vaccination ]
    Proportion of IgG antibody titers ≥0.1 IU/mL


Secondary Outcome Measures :
  1. Opsonophagocytic assay (OPA) titers for PCV13 [ Time Frame: 4 weeks after vaccination ]
    Four capsule serotypes: 1, 5, 18C and 19A


Other Outcome Measures:
  1. Frequency and duration of local and systemic adverse events [ Time Frame: During 4 weeks after vaccination ]
    The safety profiles of co-administration of Td and PCV13 will be compared to those of single vaccination.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Joon Young Song, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03552445     History of Changes
Other Study ID Numbers: 2013GR0005
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tetanus
Diphtheria
Pneumococcal Infections
Tetany
Clostridium Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms
Corynebacterium Infections
Actinomycetales Infections
Streptococcal Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs