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OpenTrials
Completed

NCT Number: NCT06793826

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

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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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Haemophilus Influenzae Type b Immunisation Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

2 month–6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site Number : 002, Cheonan, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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

Biological

prefilled syringe injection intramuscular

Other names: Hexaxim®

Primary outcomes

  1. Number of participants reporting immediate adverse events/adverse drug reactions (AEs/ADRs)

    Time frame: Within 30 minutes post-vaccination

    Unsolicited (spontaneously reported) systemic AEs/ADRs

  2. Number of participants reporting serious adverse events / adverse drug reactions (SAEs / SADRs)

    Time frame: Up to 43 days post-vaccination

    SAEs and SADRs

  3. Number of participants reporting solicited injection site and systemic reactions

    Time frame: Up to 7 days post-vaccination

    Solicited injection site reactions: tenderness; erythema; site swelling Solicited systemic reactions: vomiting; crying abnormal; drowsiness; appetite loss; irritability

  4. Number of participants reporting unsolicited non-serious AEs/ADRs

    Time frame: Up to 28 days post-vaccination

    Unsolicited non-serious AEs and ADRs

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

Post-marketing Surveillance Study for the Safety of Hexaxim®, a DTaP-IPV- HB-PRP~T Vaccine Administered to Infants From 2 Months of Age in Republic of Korea

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Feb 18, 2026

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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