Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine
1 other identifier
interventional
462
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2013
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedFirst Submitted
Initial submission to the registry
May 17, 2018
CompletedFirst Posted
Study publicly available on registry
June 11, 2018
CompletedJune 11, 2018
May 1, 2018
2.5 years
May 17, 2018
May 29, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
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
Diphtheria antibody titers at day 28 post-vaccination
IgG antibody titers by enzyme linked immunosorbent assay (ELISA)
4 weeks after vaccination
Tetanus seroprotection rate at day 28 post-vaccination
Proportion of IgG antibody titers ≥0.1 IU/mL
4 weeks after vaccination
Diphtheria seroprotection rate at day 28 post-vaccination
Proportion of IgG antibody titers ≥0.1 IU/mL
4 weeks after vaccination
Secondary Outcomes (1)
Opsonophagocytic assay (OPA) titers for PCV13
4 weeks after vaccination
Other Outcomes (1)
Frequency and duration of local and systemic adverse events
During 4 weeks after vaccination
Study Arms (3)
Tetanus-diphtheria (Td) and PCV13
ACTIVE COMPARATORPCV13 alone
ACTIVE COMPARATORTd alone
ACTIVE COMPARATORInterventions
154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0
Eligibility Criteria
You may qualify if:
- Adults aged ≥50 years who signed the informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Song JY, Cheong HJ, Noh JY, Choi MJ, Yoon JG, Lee SN, Kang SH, Jeong EJ, Jo YM, Kim WJ. Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in >/= 50-year-old adults. BMC Infect Dis. 2018 Dec 5;18(1):628. doi: 10.1186/s12879-018-3479-9.
PMID: 30518331DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 17, 2018
First Posted
June 11, 2018
Study Start
November 1, 2013
Primary Completion
April 30, 2016
Study Completion
February 28, 2018
Last Updated
June 11, 2018
Record last verified: 2018-05