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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05832333

Enrollment

682

Registered

2023-04-27

Start date

2019-10-05

Completion date

2022-02-07

Last updated

2023-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Brief summary

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

Detailed description

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

Interventions

BIOLOGICALVaxigripTetra®

Suspension for injection Injection intramuscular

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Months to 35 Months

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Occurence of solicited injection site or systemic reactions	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)	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	Up to 21(+7) days after vaccination	Percentage of participants with SAEs, including AESIs, throughout the study

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026