Healthy Volunteers, Meningococcal Immunization
Conditions
Brief summary
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.
Interventions
BIOLOGICALMeningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.
Sponsors
Sanofi
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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) |
Countries
South Korea
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed