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

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

682 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-05

Study Completion Date

2022-02-07

Brief Summary

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

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Detailed Description

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

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®

Suspension for injection 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 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

Minimum Eligible Age

6 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes