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

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

Completed

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 month–35 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Site 003, Gangwon-do, South Korea

About this study

The planned duration of each participant's participation in the study will be 21 to 28 days.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VaxigripTetra®

Biological

Suspension for injection Injection intramuscular

Other names: Quadrivalent influenza vaccine (split-virion, inactivated) - QIV

Primary outcomes

Occurence of solicited injection site or systemic reactions

Time frame: Up to 7 days after vaccination
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
Occurence of unsolicited adverse events (AEs)

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

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
Occurrence of serious adverse events (SAEs) throughout the study participation

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

Percentage of participants with SAEs, including AESIs, throughout the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2022
Study completion: 2022
First posted: Apr 27, 2023
Registry last updated: Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed