TetanusPhase 4NCT03552445
Immunogenicity and Safety of a Tetanus-diphtheria Vaccine and a 13-valent Pneumococcal Conjugate Vaccine
A Phase 4 study testing Tetanus-diphtheria (Td) and PCV13, PCV13 alone and Td alone in people with Tetanus and Diphtheria, run by Korea University Guro Hospital.
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tetanus, Diphtheria, Pneumococcal Infections
- What is being tested?
- Tetanus-diphtheria (Td) and PCV13, PCV13 alone and Td alone
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 462 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2013to 28 Feb 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged ≥50 years who signed the informed consent
Who cannot join
- 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
About this study
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
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.
Read the 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).
- Conditions
- Tetanus, Diphtheria, Pneumococcal Infections
- Being tested
- Tetanus-diphtheria (Td) and PCV13, PCV13 alone, Td alone
- Medical subject headings
- Tetanus, Diphtheria, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus-diphtheria (Td) and PCV13Biological
154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0
PCV13 aloneBiological
154 PCV13 recipients: one vaccine injection administered on Day 0
Td aloneBiological
437 Td recipients: one vaccine injection administered on Day 0
| Study group | Role | What they receive |
|---|---|---|
| Tetanus-diphtheria (Td) and PCV13 | Active comparator | Not described Receives: Biological: Tetanus-diphtheria (Td) and PCV13 |
| PCV13 alone | Active comparator | Not described Receives: Biological: PCV13 alone |
| Td alone | Active comparator | Not described Receives: Biological: Td alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks after vaccination
Diphtheria antibody titers at day 28 post-vaccination
IgG antibody titers by enzyme linked immunosorbent assay (ELISA)
Measured: 4 weeks after vaccination
Tetanus seroprotection rate at day 28 post-vaccination
Proportion of IgG antibody titers ≥0.1 IU/mL
Measured: 4 weeks after vaccination
Diphtheria seroprotection rate at day 28 post-vaccination
Proportion of IgG antibody titers ≥0.1 IU/mL
Measured: 4 weeks after vaccination
Secondary outcomes (1)
Opsonophagocytic assay (OPA) titers for PCV13
Four capsule serotypes: 1, 5, 18C and 19A
Measured: 4 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start1 Nov 2013
- Primary completion30 Apr 2016
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TetanusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joon Young Song, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03552445
- Sponsor's protocol ID
- 2013GR0005
- Status last verified
- May 2018
- First submitted
- 17 May 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30518331
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03552445
- Acronym / sponsor ID
- 2013GR0005
- Conditions
- Tetanus, Diphtheria, Pneumococcal Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 1 Nov 2013 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tetanus-diphtheria (Td) and PCV13 | Active comparator | Biological: Tetanus-diphtheria (Td) and PCV13 |
| PCV13 alone | Active comparator | Biological: PCV13 alone |
| Td alone | Active comparator | Biological: Td alone |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged ≥50 years who signed the informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetanus-diphtheria (Td) and PCV13154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0 | Biological | Tetanus-diphtheria (Td) and PCV13 |
| PCV13 alone154 PCV13 recipients: one vaccine injection administered on Day 0 | Biological | PCV13 alone |
| Td alone437 Td recipients: one vaccine injection administered on Day 0 | Biological | Td alone |
Primary outcome
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
Diphtheria antibody titers at day 28 post-vaccination
Time frame: 4 weeks after vaccination
IgG antibody titers by enzyme linked immunosorbent assay (ELISA)
Tetanus seroprotection rate at day 28 post-vaccination
Time frame: 4 weeks after vaccination
Proportion of IgG antibody titers ≥0.1 IU/mL
Diphtheria seroprotection rate at day 28 post-vaccination
Time frame: 4 weeks after vaccination
Proportion of IgG antibody titers ≥0.1 IU/mL
1 secondary outcome
Opsonophagocytic assay (OPA) titers for PCV13
Time frame: 4 weeks after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Derived from this study: PubMed 30518331Song 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetanus-diphtheria (Td) and PCV13, PCV13 alone and Td alone in people with Tetanus and Diphtheria, run by Korea University Guro Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tetanus antibody titers at day 28 post-vaccination (time frame: 4 weeks after vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03552445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.