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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1317-8004 | Registry Identifier | ICTRP |
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This surveillance is to investigate the safety profile of MenQuadfi®, when administered to participants aged 6 weeks to 55 years under the real-world clinical practice settings as per approved indications, including the Adverse Drug Reactions (ADRs)*.
*It includes ADRs that were not fully recognized in clinical practice, or unexpected ADRs which refer to those not listed in the approved drug labeling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants aged 6 weeks to 55 years old | Participants vaccinated with MenQuadfi® for the first time as per ordinary healthcare setting at the day of inclusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine | Biological | This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with solicited injection site and systemic reactions | Up to 7 days after vaccination | |
| Number of participants with unsolicited non-serious Adverse Events (AEs) and Adverse Drug Reactions (ADRs), including unexpected AEs and ADRs | Up to 30 days after vaccination | |
| Number of participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), and Serious Adverse Drug Reactions (SADRs) | From Day 01 up to the end of the study (approximately 44 days after inclusion in individuals aged 2-55 years; approximately 4 months in infants aged 6 months to <24 months; approximately 13 months in infants aged 6 weeks to <6 months) |
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Inclusion Criteria:
Exclusion Criteria:
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
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This is a multi-center, observational cohort active safety surveillance study, designed to be conducted under standard healthcare setting of the Republic of Korea, in accordance with "Standard for Re-examination of New Drugs".
This is a single country study which will be conducted only in Korea with a target number of 706 participants.
Investigators will recruit participants until the targeted number of participants (as contracted with the sponsor) has been obtained; each participant will be assigned an identification number in the order of enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency email recommended (Toll free for US & Canada) | Contact | 800-633-1610 | option 6 | Contact-US@sanofi.com |
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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://vivli.org
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