Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea
28 juli 2026 bijgewerkt door: Sanofi
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.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Studietype
Observationeel
Inschrijving (Geschat)
706
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Trial Transparency email recommended (Toll free for US & Canada)
- Telefoonnummer: option 6 800-633-1610
- E-mail: contact-us@sanofi.com
Studie Locaties
-
-
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Busan, Zuid -Korea, 49408
- Werving
- Investigational Site Number: 410009
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Daegu, Zuid -Korea, 41794
- Werving
- Investigational Site Number: 410011
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Goyang, Zuid -Korea, 10234
- Werving
- Investigational Site Number: 410003
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Gwangju, Zuid -Korea, 61665
- Werving
- Investigational Site Number: 410008
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Hanam, Zuid -Korea, 12919
- Werving
- Investigational Site Number: 410010
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Iksan, Zuid -Korea, 54639
- Werving
- Investigational Site Number: 410006
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Seongnam, Zuid -Korea, 13558
- Werving
- Investigational Site Number: 410005
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Seoul, Zuid -Korea, 06132
- Werving
- Investigational Site Number: 410004
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Seoul, Zuid -Korea, 06614
- Werving
- Investigational Site Number: 410007
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
Inclusion Criteria:
- Aged 6 weeks to 55 years on the day of MenQuadfi® vaccination
- Evidence of a personally signed and dated informed consent document indicating that the participant or their parent(s)/other legally acceptable representative(s), if applicable, have been informed of all pertinent aspects of the study
- Participants who have been vaccinated with MenQuadfi® for the first time as per ordinary healthcare setting at the day of inclusion in the study according to the approved local product label
Exclusion Criteria:
- Participating or planning participation in any other clinical studies investigating a vaccine, drug, medical device, or medical procedure at the time of the study enrolment (or in 4 weeks preceding the enrolment)
- Having a previous history of enrollment in this study (participants who have already been enrolled once in this study are not eligible for re-enrollment)
- Being applicable to contraindications in the approved local product label of MenQuadfi®; anyone with a known systemic hypersensitivity reaction to any component of this vaccine or after previous administration of the vaccine or a vaccine containing the same components
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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
|
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Number of participants with solicited injection site and systemic reactions
Tijdsspanne: Up to 7 days after vaccination
|
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
Tijdsspanne: Up to 30 days after vaccination
|
Up to 30 days after vaccination
|
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Number of participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), and Serious Adverse Drug Reactions (SADRs)
Tijdsspanne: 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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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)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juli 2026
Primaire voltooiing (Geschat)
23 november 2027
Studie voltooiing (Geschat)
23 november 2027
Studieregistratiedata
Eerst ingediend
26 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
26 mei 2026
Eerst geplaatst (Werkelijk)
2 juni 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
29 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
28 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- MEQ00085
- U1111-1317-8004 (Register-ID: ICTRP)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .