Yellow FeverNCT03541694
Passive Enhanced Safety Surveillance of Stamaril® Vaccine in Korea
An observational study of Yellow Fever, run by Sanofi Pasteur, a Sanofi Company at 1 site in South Korea.
Trial summary
This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Yellow Fever
- What is being tested?
- Stamaril®
- Type of treatment
- Vaccines
- How many people
- 622 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Apr 2018to 30 May 2018
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants who have been vaccinated against yellow fever with Stamaril® vaccine in Korean yellow fever vaccination centers during the enhanced surveillance period.
Vaccination with Stamaril® vaccine in routine practice in Korea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Passive Enhanced Safety Surveillance of the Live Attenuated Yellow Fever Virus Vaccine Stamaril® in Korea
This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.
Read the detailed description
This ESS replaces the routing post-marketing surveillance required after product approval in Korea.
- Conditions
- Yellow Fever
- Being tested
- Stamaril®
- Keywords
- Yellow fever, Stamaril®
- Medical subject headings
- Yellow Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stamaril®Biological
Routine vaccination with Stamaril yellow fever vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting suspected related adverse events
Spontaneous reporting of suspected related adverse events
Measured: Within 30 days after vaccination
Secondary outcomes (1)
Number of participants reporting suspected serious related adverse events
Spontaneous reporting of serious suspected related adverse events
Measured: Within 30 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 posted30 May 2018
- Study start11 Apr 2018
- Primary completion30 May 2018
- Study completion30 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Yellow FeverStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541694
- Sponsor's protocol ID
- STA10
- Status last verified
- Jul 2018
- First submitted
- 23 Apr 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Enhanced Safety Surveillance of the Live Attenuated Yellow Fever Virus Vaccine Stamaril® in Korea
- ClinicalTrials.gov ID
- NCT03541694
- Acronym / sponsor ID
- STA10
- Conditions
- Yellow Fever
- Keywords
- Yellow fever, Stamaril®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 30 May 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.
This is a passive enhance safety surveillance (ESS) of Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.
Detailed description
This ESS replaces the routing post-marketing surveillance required after product approval in Korea.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants who have been vaccinated against yellow fever with Stamaril® vaccine in Korean yellow fever vaccination centers during the enhanced surveillance period.
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 |
|---|---|---|
| Stamaril®Routine vaccination with Stamaril yellow fever vaccine | Biological | – |
Primary outcome
Number of participants reporting suspected related adverse events
Time frame: Within 30 days after vaccination
Spontaneous reporting of suspected related adverse events
1 secondary outcome
Number of participants reporting suspected serious related adverse events
Time frame: Within 30 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 26 Mar 2019.
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Study on an Investigational Yellow Fever Vaccine Compared With YF-VAX in Adults in the USA
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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.
Medical Director study director
Sanofi Pasteur, a Sanofi Company
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Yellow Fever, run by Sanofi Pasteur, a Sanofi Company at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2019. 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.
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?
Number of participants reporting suspected related adverse events (time frame: Within 30 days after vaccination). 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 26 Mar 2019.