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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-01

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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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

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Tetanus Diphtheria Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tetanus-diphtheria (Td) and PCV13

Group Type ACTIVE_COMPARATOR

Tetanus-diphtheria (Td) and PCV13

Intervention Type BIOLOGICAL

154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0

PCV13 alone

Group Type ACTIVE_COMPARATOR

PCV13 alone

Intervention Type BIOLOGICAL

154 PCV13 recipients: one vaccine injection administered on Day 0

Td alone

Group Type ACTIVE_COMPARATOR

Td alone

Intervention Type BIOLOGICAL

437 Td recipients: one vaccine injection administered on Day 0

Interventions

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Tetanus-diphtheria (Td) and PCV13

154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0

Intervention Type BIOLOGICAL

PCV13 alone

154 PCV13 recipients: one vaccine injection administered on Day 0

Intervention Type BIOLOGICAL

Td alone

437 Td recipients: one vaccine injection administered on Day 0

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes