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Multi-center, observational, active safety surveillance study in participants aged 6 to 35 months in Korea under routine clinical practices.
The planned duration of each participant's participation in the study will be 21 to 28 days.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VaxigripTetra® | Biological | Suspension for injection Injection intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of solicited injection site or systemic reactions | Percentage of participants reporting
| 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 | 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 | Up to 21(+7) days after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
- 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
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 003 | Gangwon-do | South Korea | ||||
| Site 002 |
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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| Gwangju |
| South Korea |
| Site 004 | Gyeonggi-do | South Korea |
| Site 005 | Gyeonggi-do | South Korea |
| Site 008 | Gyeonggi-do | South Korea |
| Site 011 | Gyeonggi-do | South Korea |
| Site 015 | Gyeonggi-do | South Korea |
| Site 006 | Gyeongsangnam-do | South Korea |
| Site 010 | Gyeongsangnam-do | South Korea |
| Site 009 | Seoul | South Korea |
| Site 012 | Seoul | South Korea |
| Site 014 | Seoul | South Korea |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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