CompletedNot Applicable

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

South Korea713 participantsStarted 2025-01-17

Plain-language summary

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

Who can participate

Age range

2 Months – 6 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Within 30 minutes post-vaccination

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

Timeframe: Up to 43 days post-vaccination

Number of participants reporting solicited injection site and systemic reactions

Timeframe: Up to 7 days post-vaccination

Number of participants reporting unsolicited non-serious AEs/ADRs

Timeframe: Up to 28 days post-vaccination

Trial details

NCT IDNCT06793826

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-01-15

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