InfluenzaNCT05406180
Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) in Subjects Aged 3 Years Old and Above
An observational study of Influenza, run by Sanofi at 10 sites in South Korea.
Trial summary
The objective is to describe the safety profile after 1 dose of VaxigripTetra inj. administered in subjects aged 3 years old and above under routine clinical practice. The planned duration of each subject's participation in the study will be 21 to 28 days. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VaxigripTetra inj.
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 675 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 10 Oct 2018to 27 Dec 2019
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects aged 3 years old and above will be enrolled after receipt of one dose of VaxigripTetra inj. during a routine health care visit. Subjects will be enrolled on the day of vaccination and will be followed-up for one vaccination whatever their age at enrolment. Therefore, in case of the subjects under 9 years old (between 3 to 8 years of age), who may receive two doses depending on their previous influenza vaccination history, only one dose (either first or second vaccination) for each subject will be accounted for the study. The planned duration of each subject's participation in the study will be 21 to 28 days. Planned number of subjects: 670 subjects aged 3 years old and above Planned number of country: 1 (Republic of Korea) Planned number of sites: 10
Who may be able to join
- Aged 3 years and above on the day of enrollment
- For subjects aged 3 to 18 years: Informed consent form has been signed and dated by the parent or other legally acceptable representative.
- For subjects 19 years and above: Informed consent form has been signed and dated by the subject.
- Receipt of one dose of VaxigripTetra inj. (on the day of inclusion) as part of routine clinical practice according to the approved local product insert
Who cannot join
- Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Site 011
Changwon
Site 009
Donghae-si, Gangwon-do
Site 012
Gwangju
Site 003
Gyeonggi-do
Site 005
Gyeonggi-do
Site 010
Gyeonggi-do
Site 004
Incheon
Site 007
Incheon
Site 008
Incheon
Site 002
Seoul
About this study
Official title: Postmarketing Surveillance Study for Use of Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) Administered Via the Intramuscular Route in Subjects Aged 3 Years Old and Above in the Republic of Korea
The objective is to describe the safety profile after 1 dose of VaxigripTetra inj. administered in subjects aged 3 years old and above under routine clinical practice.
The planned duration of each subject's participation in the study will be 21 to 28 days.
- Conditions
- Influenza
- Being tested
- VaxigripTetra inj.
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VaxigripTetra inj.Biological
Also called Quadrivalent influenza vaccine (split-virion, inactivated) - QIV
Suspension for injection in a pre-filled syringe Injection intramuscular
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with solicited injection site or systemic reactions
Percentage of participants reporting
- injection site reactions: pain, erythema, swelling, induration, ecchymosis
- systemic reactions: fever, headache, malaise, myalgia, shivering
Measured: Up to 7 days after vaccination
Number of participants with unsolicited adverse events
Percentage of participants with unsolicited (spontaneously reported) injection site reactions occurring within 28 days after each injection and unsolicited systemic AEs between each injection and up to 28 days after the last injection
Measured: Up to Day 28
Number of participants with serious adverse events (SAEs)
Percentage of participants with SAEs, including AESIs, throughout the study
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start10 Oct 2018
- Primary completion27 Dec 2019
- Study completion27 Dec 2019
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 InfluenzaStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- 675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406180
- Sponsor's protocol ID
- GQM13
- Status last verified
- May 2022
- First submitted
- 19 May 2022
- Last updated
- 6 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.vivli.org
Publications
Lim S, Li X, Syrkina O, Fournier M. Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea. Infect Dis Ther. 2022 Oct;11(5):2035-2043. doi: 10.1007/s40121-022-00685-x. Epub 2022 Sep 7.
PubMed 36070176
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Surveillance Study for Use of Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) Administered Via the Intramuscular Route in Subjects Aged 3 Years Old and Above in the Republic of Korea
- ClinicalTrials.gov ID
- NCT05406180
- Acronym / sponsor ID
- GQM13
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 675 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 27 Dec 2019 (actual)
- First posted
- 6 Jun 2022 (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 objective is to describe the safety profile after 1 dose of VaxigripTetra inj. administered in subjects aged 3 years old and above under routine clinical practice.
The planned duration of each subject's participation in the study will be 21 to 28 days.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects aged 3 years old and above will be enrolled after receipt of one dose of VaxigripTetra inj. during a routine health care visit. Subjects will be enrolled on the day of vaccination and will be followed-up for one vaccination whatever their age at enrolment. Therefore, in case of the subjects under 9 years old (between 3 to 8 years of age), who may receive two doses depending on their previous influenza vaccination history, only one dose (either first or second vaccination) for each subject will be accounted for the study. The planned duration of each subject's participation in the study will be 21 to 28 days. Planned number of subjects: 670 subjects aged 3 years old and above Planned number of country: 1 (Republic of Korea) Planned number of sites: 10
Key inclusion criteria (4 listed)
- Aged 3 years and above on the day of enrollment
- For subjects aged 3 to 18 years: Informed consent form has been signed and dated by the parent or other legally acceptable representative.
- For subjects 19 years and above: Informed consent form has been signed and dated by the subject.
- Receipt of one dose of VaxigripTetra inj. (on the day of inclusion) as part of routine clinical practice according to the approved local product insert
Key exclusion criteria (1 listed)
- Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) or planned participation during the present study period in a clinical study investigating a vaccine, drug, medical device, or medical procedure
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 |
|---|---|---|
| VaxigripTetra inj.Also: Quadrivalent influenza vaccine (split-virion, inactivated) - QIVSuspension for injection in a pre-filled syringe Injection intramuscular | Biological | – |
Primary outcome
Number of participants with solicited injection site or systemic reactions
Time frame: Up to 7 days after vaccination
Percentage of participants reporting * injection site reactions: pain, erythema, swelling, induration, ecchymosis * systemic reactions: fever, headache, malaise, myalgia, shivering
Number of participants with unsolicited adverse events
Time frame: Up to Day 28
Percentage of participants with unsolicited (spontaneously reported) injection site reactions occurring within 28 days after each injection and unsolicited systemic AEs between each injection and up to 28 days after the last injection
Number of participants with serious adverse events (SAEs)
Time frame: Up to Day 28
Percentage of participants with SAEs, including AESIs, throughout the study
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 6 Jun 2022.
- Derived from this study: PubMed 36070176Lim S, Li X, Syrkina O, Fournier M. Post-marketing Surveillance of a Quadrivalent Influenza Vaccine (Vaxigrip Tetra) in South Korea. Infect Dis Ther. 2022 Oct;11(5):2035-2043. doi: 10.1007/s40121-022-00685-x. Epub 2022 Sep 7.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.vivli.org
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Sanofi at 10 sites 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 4 inclusion and 1 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 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 with solicited injection site or systemic reactions (time frame: Up to 7 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?
On the ClinicalTrials.gov record for NCT05406180, 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 6 Jun 2022.