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Completed

NCT Number: NCT03552445

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

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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Key information

Conditions

Tetanus Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Corynebacterium Infections Diphtheria Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tetanus-diphtheria (Td) and PCV13

Biological

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

PCV13 alone

Biological

154 PCV13 recipients: one vaccine injection administered on Day 0

Td alone

Biological

437 Td recipients: one vaccine injection administered on Day 0

Primary outcomes

  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 outcomes

  1. Opsonophagocytic assay (OPA) titers for PCV13

    Time frame: 4 weeks after vaccination

    Four capsule serotypes: 1, 5, 18C and 19A

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Korea University Guro Hospital

Other

Registry information

Official study title

Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine After Concomitant Vaccination in ≥50-year-old Adults

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Jun 11, 2018
Registry last updated
Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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