NCT05832333Completed

Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra®) in Subjects Aged 6 to 35 Months

Name: Clinical Trial NCT05832333
Creator: Sanofi
Keywords: Influenza, VaxigripTetra®, biological, clinical trial, South Korea

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

SanofiClinicalTrials.govbiological

Verified

Study focus

Disease/Condition: Influenza
Drug/Device/Intervention: VaxigripTetra®
Study type: Observational
Intervention type: biological

Sponsor & location

Primary sponsor: Sanofi
Location: Gangwon-do,Gwangju,Gyeonggi-do,Gyeonggi-do,Gyeonggi-do,Gyeonggi-do,Gyeonggi-do,Gyeongsangnam-do,Gyeongsangnam-do,Seoul,Seoul,Seoul, South Korea

Timeline & enrollment

Phase: N/A
Start date: Oct 05, 2019
End date: Feb 07, 2022
Enrollment: 682 participants

Primary outcome

Occurence of solicited injection site or systemic reactions,Occurence of unsolicited adverse events (AEs),Occurrence of serious adverse events (SAEs) throughout the study participation

Summary

Multi-center, observational, active safety surveillance study in participants aged 6 to 35 months in Korea under routine clinical practices.

ICD-10 classifications

Influenza and pneumoniaInfluenza due to identified seasonal influenza virusInfluenza with other manifestations, seasonal influenza virus identifiedInfluenza with pneumonia, seasonal influenza virus identifiedInfluenza due to identified zoonotic or pandemic influenza virus

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT05832333
Type: Non-Device Trial

About this record

Access comprehensive clinical trial information for NCT05832333 through Pure Global AI's free database. This phase not specified trial is sponsored by Sanofi and is currently Completed. The study focuses on Influenza. Target enrollment is 682 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.