Postmarketing Surveillance Study for Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) in Subjects Aged 3 Years Old and Above

The objective is to describe the safety profile after 1 dose of VaxigripTetra inj. administered in subjects aged 3 years old and above under routine clinical practice.

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

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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

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Site 009, Donghae-si, Gangwon-do, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Aged 3 years and above on the day of enrollment
For subjects aged 3 to 18 years: Informed consent form has been signed and dated by the parent or other legally acceptable representative.
For subjects 19 years and above: Informed consent form has been signed and dated by the subject.
Receipt of one dose of VaxigripTetra inj. (on the day of inclusion) as part of routine clinical practice according to the approved local product insert

Exclusion criteria

Participation at the time of study enrollment (or in the 4 weeks preceding the enrollment) 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 inj.

Biological

Suspension for injection in a pre-filled syringe Injection intramuscular

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

Primary outcomes

Number of participants with 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: fever, headache, malaise, myalgia, shivering
Number of participants with unsolicited adverse events

Time frame: Up to Day 28

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
Number of participants with serious adverse events (SAEs)

Time frame: Up to Day 28

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Postmarketing Surveillance Study for Use of Quadrivalent Influenza Vaccine (VaxigripTetra Inj.) Administered Via the Intramuscular Route in Subjects Aged 3 Years Old and Above in the Republic of Korea

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jun 6, 2022
Registry last updated: Jun 6, 2022

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.

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Completed