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

Sponsor

Korea University Guro Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03552445

Collaborator

(none)

462

Enrollment

Arms

51.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tetanus Diphtheria Pneumococcal Infections	Biological: Tetanus-diphtheria (Td) and PCV13 Biological: PCV13 alone Biological: Td alone	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

462 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 1, 2013

Actual Primary Completion Date :

Apr 30, 2016

Actual Study Completion Date :

Feb 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tetanus-diphtheria (Td) and PCV13	Biological: Tetanus-diphtheria (Td) and PCV13 154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0
Active Comparator: PCV13 alone	Biological: PCV13 alone 154 PCV13 recipients: one vaccine injection administered on Day 0
Active Comparator: Td alone	Biological: Td alone 437 Td recipients: one vaccine injection administered on Day 0

Arm

Intervention/Treatment

Active Comparator: Tetanus-diphtheria (Td) and PCV13

Biological: Tetanus-diphtheria (Td) and PCV13

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

Active Comparator: PCV13 alone

Biological: PCV13 alone

154 PCV13 recipients: one vaccine injection administered on Day 0

Active Comparator: Td alone

Biological: Td alone

437 Td recipients: one vaccine injection administered on Day 0

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

Frequency and duration of local and systemic adverse events [During 4 weeks after vaccination]
The safety profiles of co-administration of Td and PCV13 will be compared to those of single vaccination.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Korea University Guro Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joon Young Song, Professor, Korea University Guro Hospital

ClinicalTrials.gov Identifier:

NCT03552445

Other Study ID Numbers:

2013GR0005

First Posted:

Jun 11, 2018

Last Update Posted:

Jun 11, 2018

Last Verified:

May 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tetanus

Diphtheria

Pneumococcal Infections

Tetany

Study Results

No Results Posted as of Jun 11, 2018