Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea

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

RECRUITING

Total Enrollment

690 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-17

Study Completion Date

2026-04-13

Brief Summary

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Primary objectives:

To investigate the incidence of adverse events occurred following administration of Hexaxim in infants from 2 months of age under routine clinical practice, as per approved indications

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Detailed Description

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The duration of each enrolled participant's participation in the study will be up to 36 or 43 days.

Conditions

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Hepatitis B Haemophilus Influenzae Type b Immunisation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

Infants from 2 months of age vaccinated with 1 dose of Hexaxim on the day of enrollment

DTaP-IPV-Hep B-PRP-T combined vaccine

Intervention Type BIOLOGICAL

prefilled syringe injection intramuscular

Interventions

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DTaP-IPV-Hep B-PRP-T combined vaccine

prefilled syringe injection intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Hexaxim®

Eligibility Criteria

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Inclusion Criteria

* An infant aged 2 months or more on the day of enrollment
* Infant whose parent or legal representative has signed and dated the ICF
* Receipt of 1 dose of Hexaxim on the day of enrollment according to the approved local product label (regardless of vaccinated dose)

Exclusion Criteria

* Deviational use (off-label vaccination) from the approval local product label of Hexaxim
* Previous history of enrollment in this study
* 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

2 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes