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

Sanofi682 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

682

Conditions

Influenza

Interventions

VaxigripTetra®BIOLOGICAL

Suspension for injection Injection intramuscular

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 35 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 6 to 35 months on the day of enrolment * Informed consent form has been signed and dated by the parent or other legally acceptable representative * Receipt of one dose of VaxigripTetra® on the day of inclusion in routine practice according to the approved local product insert 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

Locations (12)

Site 003

Gangwon-do, South Korea

Site 002

Gwangju, South Korea

Site 004

Gyeonggi-do, South Korea

Site 005

Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Occurence of solicited injection site or systemic reactions

Percentage of participants reporting * injection site reactions: pain, erythema, swelling, induration, ecchymosis * systemic reactions for infants and toddlers ≤ 23 months: fever, vomiting ,crying abnormal, drowsiness, appetite lost, irritability * systemic reactions for children aged 2 to 3 years: fever, headache, malaise, myalgia, shivering

Time frame: 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

Time frame: 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

Time frame: Up to 21(+7) days after vaccination

Data from ClinicalTrials.gov

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