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

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552445
• Other study ID #: 2013GR0005
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2013
• Est. completion date: February 28, 2018

Study information

• Verified date: May 2018
• Source: Korea University Guro Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: February 28, 2018
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Pneumococcal Infections
• Tetanus

Intervention

Biological:
• Tetanus-diphtheria (Td) and PCV13
154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0
• PCV13 alone
154 PCV13 recipients: one vaccine injection administered on Day 0
• Td alone
437 Td recipients: one vaccine injection administered on Day 0

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency and duration of local and systemic adverse events	The safety profiles of co-administration of Td and PCV13 will be compared to those of single vaccination.	During 4 weeks after vaccination
Primary	Tetanus antibody titers at day 28 post-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	4 weeks after vaccination
Primary	Diphtheria antibody titers at day 28 post-vaccination	IgG antibody titers by enzyme linked immunosorbent assay (ELISA)	4 weeks after vaccination
Primary	Tetanus seroprotection rate at day 28 post-vaccination	Proportion of IgG antibody titers =0.1 IU/mL	4 weeks after vaccination
Primary	Diphtheria seroprotection rate at day 28 post-vaccination	Proportion of IgG antibody titers =0.1 IU/mL	4 weeks after vaccination
Secondary	Opsonophagocytic assay (OPA) titers for PCV13	Four capsule serotypes: 1, 5, 18C and 19A	4 weeks after vaccination