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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

675 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-10

Study Completion Date

2019-12-27

Brief Summary

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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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Detailed Description

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Conditions

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Influenza

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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VaxigripTetra inj.

Suspension for injection in a pre-filled syringe Injection intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Quadrivalent influenza vaccine (split-virion, inactivated) - QIV

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes