Pneumococcal DiseasePhase 1NCT04830358
Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
A Phase 1 study testing EuPCV15 and Prevenar13 in people with Pneumococcal Disease, run by EuBiologics Co.,Ltd at 1 site in South Korea.
Trial summary
The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Disease
- What is being tested?
- EuPCV15 and Prevenar13
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 May 2020to 1 Feb 2021
- Phase
- Phase 1
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 19 to 50 years old
- Participants willing to give written informed consent to participate in the trial
Who cannot join
- History of invasive pneumococcal infection within 5 years at screening
- Known hypersensitivity to any component of the study vaccine
- Immune deficiency or immunosuppressive disorder
- Immunized with any licensed vaccine within 4 weeks prior to screening
- Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
- Participants who in the opinion of the investigator will not be able to comply with any of the protocol required procedure
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Seoul St.Mary's Hospital
Seoul
About this study
Official title: A Single Center, Randomized, Single-blind, Active Comparator Phase 1 Clinical Trial to Assess the Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.
- Conditions
- Pneumococcal Disease
- Being tested
- EuPCV15, Prevenar13
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuPCV15Biological
15-valent Pneumococcal conjugate vaccine
Prevenar13Biological
13-valent Pneumococcal conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| EuPCV15 | Experimental | Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0. Receives: Biological: EuPCV15 |
| Prevenar13 | Active comparator | Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0. Receives: Biological: Prevenar13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Solicited AEs (Local and Systemic)
Measured: within 14 days after vaccination
Incidence of Unsolicited AEs
Measured: within 28 days after vaccination
Incidence of SAEs
Measured: within 180 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start28 May 2020
- Primary completion14 Aug 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal DiseaseStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuBiologics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830358
- Sponsor's protocol ID
- EuVCT_PCV101
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Single-blind, Active Comparator Phase 1 Clinical Trial to Assess the Safety and Immunogenicity of the 'EuPCV15' in Healthy Korean Adults
- ClinicalTrials.gov ID
- NCT04830358
- Acronym / sponsor ID
- EuVCT_PCV101
- Conditions
- Pneumococcal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 28 May 2020 (actual)
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 5 Apr 2021 (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.
The safety and immunogenicity of EuPCV15 compared to Prevenar13 are assessed in healthy adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EuPCV15 | Experimental | Biological: EuPCV15Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0. |
| Prevenar13 | Active comparator | Biological: Prevenar13Single dose of Pneumococcal Conjugate Vaccine will be administered intramuscularly at Day 0. |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy adults aged 19 to 50 years old
- Participants willing to give written informed consent to participate in the trial
Key exclusion criteria (6 listed)
- History of invasive pneumococcal infection within 5 years at screening
- Known hypersensitivity to any component of the study vaccine
- Immune deficiency or immunosuppressive disorder
- Immunized with any licensed vaccine within 4 weeks prior to screening
- Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
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 |
|---|---|---|
| EuPCV1515-valent Pneumococcal conjugate vaccine | Biological | EuPCV15 |
| Prevenar1313-valent Pneumococcal conjugate vaccine | Biological | Prevenar13 |
Primary outcome
Incidence of Solicited AEs (Local and Systemic)
Time frame: within 14 days after vaccination
Incidence of Unsolicited AEs
Time frame: within 28 days after vaccination
Incidence of SAEs
Time frame: within 180 days 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 7 Oct 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EuPCV15 and Prevenar13 in people with Pneumococcal Disease, run by EuBiologics Co.,Ltd at 1 site in South Korea.
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 2 inclusion and 6 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 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of Solicited AEs (Local and Systemic) (time frame: within 14 days after vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2021.