MedTrace Logo

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

NCT03552445 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2018-06-11

No results posted yet for this study

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.

Conditions

  • Tetanus
  • Diphtheria
  • Pneumococcal Infections

Interventions

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

Sponsors & Collaborators

  • Korea University Guro Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-01
Primary Completion
2016-04-30
Completion
2018-02-28

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03552445 on ClinicalTrials.gov