Infection, MeningococcalPhase 1NCT04714229
Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
A Phase 1 study testing Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine and Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine in people with Infection, Meningococcal, run by EuBiologics Co.,Ltd at 1 site in South Korea.
Trial summary
Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection, Meningococcal
- What is being tested?
- Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine and Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
- 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
- 1 Sep 2020to 1 Sep 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects 19 to 55 years of age
- Written informed consent
- Available for all visits and telephone calls scheduled for the study
Who cannot join
- Previous or suspected disease caused by N. meningitidis
- Household and/or intimate exposure to an individual with culture-proven N. meinigitidis infection within 60 days prior to screening
- Serious acute, chronic or progressive disease as determined by investigator
- History of alcohol or substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Observer-blinded, Active Comparator Phase I Study to Assess the Safety and Immunogenicity of Meningococcal (Groups A, C, W-135 and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine
- Conditions
- Infection, Meningococcal
- Being tested
- Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine, Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal(Groups A, C, W-135, and Y) Conjugate VaccineBiological
Also called EuMCV4
0.5mL single intramuscular dose on Day 0
Meningococcal(Groups A, C, Y, and W-135) Conjugate VaccineBiological
Also called Menveo
0.5mL single intramuscular dose on Day 0
| Study group | Role | What they receive |
|---|---|---|
| EuMCV4 | Experimental | Healthy adults received 0.5mL single intramuscular dose on Day 0. Receives: Biological: Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine |
| Menveo | Active comparator | Healthy adults received 0.5mL single intramuscular dose on Day 0. Receives: Biological: Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of solicited adverse events
local and systemic AEs
Measured: within 7 days post vaccination
Occurrence of unsolicited adverse events
Measured: within 28 days post vaccination
Occurrence of serious adverse events
Measured: within 180 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start1 Sep 2020
- Primary completion1 Nov 2020
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, MeningococcalStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuBiologics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- YJ Lee, Study director, EuBiologics Co.,Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714229
- Sponsor's protocol ID
- EuVCT_MCV101
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 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, Observer-blinded, Active Comparator Phase I Study to Assess the Safety and Immunogenicity of Meningococcal (Groups A, C, W-135 and Y) Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
- ClinicalTrials.gov ID
- NCT04714229
- Acronym / sponsor ID
- EuVCT_MCV101
- Conditions
- Infection, Meningococcal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 19 Jan 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.
Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate vaccine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EuMCV4 | Experimental | Biological: Meningococcal(Groups A, C, W-135, and Y) Conjugate VaccineHealthy adults received 0.5mL single intramuscular dose on Day 0. |
| Menveo | Active comparator | Biological: Meningococcal(Groups A, C, Y, and W-135) Conjugate VaccineHealthy adults received 0.5mL single intramuscular dose on Day 0. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects 19 to 55 years of age
- Written informed consent
- Available for all visits and telephone calls scheduled for the study
Key exclusion criteria (4 listed)
- Previous or suspected disease caused by N. meningitidis
- Household and/or intimate exposure to an individual with culture-proven N. meinigitidis infection within 60 days prior to screening
- Serious acute, chronic or progressive disease as determined by investigator
- History of alcohol or substance abuse
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 |
|---|---|---|
| Meningococcal(Groups A, C, W-135, and Y) Conjugate VaccineAlso: EuMCV40.5mL single intramuscular dose on Day 0 | Biological | EuMCV4 |
| Meningococcal(Groups A, C, Y, and W-135) Conjugate VaccineAlso: Menveo0.5mL single intramuscular dose on Day 0 | Biological | Menveo |
Primary outcome
Occurrence of solicited adverse events
Time frame: within 7 days post vaccination
local and systemic AEs
Occurrence of unsolicited adverse events
Time frame: within 28 days post vaccination
Occurrence of serious adverse events
Time frame: within 180 days post 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.
YJ Lee study director
EuBiologics Co.,Ltd
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 Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine and Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine in people with Infection, Meningococcal, 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 3 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 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?
Occurrence of solicited adverse events (time frame: within 7 days post 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.