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

Phase 4

Completed

• Conditions: Tetanus; Pneumococcal Infections; Diphtheria
• Interventions: Biological: Td alone; Biological: PCV13 alone; Biological: Tetanus-diphtheria (Td) and PCV13

• Registration Number: NCT03552445
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2013-11-01
• Primary Completion: 2016-04-30
• Study Completion: 2018-02-28
• Status Verified: 2018-05
• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-05-29
• Last Update Submitted: 2018-05-29
• Study First Posted: 2018-06-11
• Last Update Posted: 2018-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 462

Inclusion Criteria

• Adults aged ≥50 years who signed the informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Td alone	Td alone	-
PCV13 alone	PCV13 alone	-
Tetanus-diphtheria (Td) and PCV13	Tetanus-diphtheria (Td) and PCV13	-

Primary Outcome Measures

Name	Time	Method
Tetanus antibody titers at day 28 post-vaccination	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
Diphtheria antibody titers at day 28 post-vaccination	4 weeks after vaccination	IgG antibody titers by enzyme linked immunosorbent assay (ELISA)
Tetanus seroprotection rate at day 28 post-vaccination	4 weeks after vaccination	Proportion of IgG antibody titers ≥0.1 IU/mL
Diphtheria seroprotection rate at day 28 post-vaccination	4 weeks after vaccination	Proportion of IgG antibody titers ≥0.1 IU/mL

Secondary Outcome Measures

Name	Time	Method
Opsonophagocytic assay (OPA) titers for PCV13	4 weeks after vaccination	Four capsule serotypes: 1, 5, 18C and 19A