InfluenzaNCT05832333
Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra®) in Subjects Aged 6 to 35 Months
An observational study of Influenza, run by Sanofi at 12 sites in South Korea.
Trial summary
Multi-center, observational, active safety surveillance study in participants aged 6 to 35 months in Korea under routine clinical practices. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- VaxigripTetra®
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 682 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 5 Oct 2019to 7 Feb 2022
- 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 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants aged 6 to 35 months will be enrolled after receipt of one dose of VaxigripTetra® during a routine health care visit. Participants will be enrolled on the day of vaccination (first or second vaccination) and will be followed-up for only one vaccination. Planned number of subjects: 670 subjects aged 6 to 35 months Planned number of country: 1 (Republic of Korea) Planned number of sites: 12
Who may be able to join
- Aged 6 to 35 months on the day of enrolment
- Informed consent form has been signed and dated by the parent or other legally acceptable representative
- Receipt of one dose of VaxigripTetra® on the day of inclusion in routine practice according to the approved local product insert
Who cannot join
- Participation at the time of study enrolment (or in the 4 weeks preceding the enrolment) 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
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Site 003
Gangwon-do
Site 002
Gwangju
Site 004
Gyeonggi-do
Site 005
Gyeonggi-do
Site 008
Gyeonggi-do
Site 011
Gyeonggi-do
Site 015
Gyeonggi-do
Site 006
Gyeongsangnam-do
Site 010
Gyeongsangnam-do
Site 009
Seoul
Site 012
Seoul
Site 014
Seoul
About this study
Official title: Post-marketing Surveillance Study for the Use of VaxigripTetra®, a Quadrivalent Influenza Vaccine Administered Via Intramuscular Route in Subjects Aged 6 to 35 Months in Republic of Korea
Multi-center, observational, active safety surveillance study in participants aged 6 to 35 months in Korea under routine clinical practices.
Read the detailed description
The planned duration of each participant's participation in the study will be 21 to 28 days.
- Conditions
- Influenza
- Being tested
- VaxigripTetra®
- 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®Biological
Also called Quadrivalent influenza vaccine (split-virion, inactivated) - QIV
Suspension for injection Injection intramuscular
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of solicited injection site or systemic reactions
Percentage of participants reporting
- injection site reactions: pain, erythema, swelling, induration, ecchymosis
- systemic reactions for infants and toddlers ≤ 23 months: fever, vomiting ,crying abnormal, drowsiness, appetite lost, irritability
- systemic reactions for children aged 2 to 3 years: fever, headache, malaise, myalgia, shivering
Measured: Up to 7 days after vaccination
Occurence of unsolicited adverse events (AEs)
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 21(+7) days after vaccination
Occurrence of serious adverse events (SAEs) throughout the study participation
Percentage of participants with SAEs, including AESIs, throughout the study
Measured: Up to 21(+7) 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 posted27 Apr 2023
- Study start5 Oct 2019
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832333
- Sponsor's protocol ID
- GQM00015
- Status last verified
- Apr 2023
- First submitted
- 11 Apr 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance Study for the Use of VaxigripTetra®, a Quadrivalent Influenza Vaccine Administered Via Intramuscular Route in Subjects Aged 6 to 35 Months in Republic of Korea
- ClinicalTrials.gov ID
- NCT05832333
- Acronym / sponsor ID
- GQM00015
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 27 Apr 2023 (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.
Multi-center, observational, active safety surveillance study in participants aged 6 to 35 months in Korea under routine clinical practices.
Detailed description
The planned duration of each participant's participation in the study will be 21 to 28 days.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants aged 6 to 35 months will be enrolled after receipt of one dose of VaxigripTetra® during a routine health care visit. Participants will be enrolled on the day of vaccination (first or second vaccination) and will be followed-up for only one vaccination. Planned number of subjects: 670 subjects aged 6 to 35 months Planned number of country: 1 (Republic of Korea) Planned number of sites: 12
Key inclusion criteria (3 listed)
- Aged 6 to 35 months on the day of enrolment
- Informed consent form has been signed and dated by the parent or other legally acceptable representative
- Receipt of one dose of VaxigripTetra® on the day of inclusion in routine practice according to the approved local product insert
Key exclusion criteria (1 listed)
- Participation at the time of study enrolment (or in the 4 weeks preceding the enrolment) 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®Also: Quadrivalent influenza vaccine (split-virion, inactivated) - QIVSuspension for injection Injection intramuscular | Biological | – |
Primary outcome
Occurence of 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 for infants and toddlers ≤ 23 months: fever, vomiting ,crying abnormal, drowsiness, appetite lost, irritability * systemic reactions for children aged 2 to 3 years: fever, headache, malaise, myalgia, shivering
Occurence of unsolicited adverse events (AEs)
Time frame: Up to 21(+7) days after vaccination
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
Occurrence of serious adverse events (SAEs) throughout the study participation
Time frame: Up to 21(+7) days after vaccination
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 27 Apr 2023.
- 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.
12 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 12 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 3 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 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Occurence of 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?
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 27 Apr 2023.