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Hexaxim vaccine safety confirmed in 713 infants

NCT ID NCT06793826

Vaccine Sponsor: Sanofi Pasteur, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study checked the safety of the Hexaxim vaccine in 713 infants aged 2 months and older in South Korea. Researchers tracked side effects like injection site reactions, fever, and crying after routine vaccination. The goal was to confirm the vaccine's safety in everyday use, not to measure how well it prevents disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hexaxim (a combined vaccine against diphtheria, tetanus, pertussis, polio, hepatitis B, and Haemophilus influenzae type b)
What this could lead to
If results are good, it confirms the vaccine's safety in routine use, supporting continued protection of infants from several serious diseases.
What could go wrong
This is a completed safety study, not a test of how well the vaccine works. It only looked for side effects, not effectiveness, and results may not apply to other countries or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

713 people

The number who actually took part.

Started

Jan 2025

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Infants aged 2 months or more will be recruited after vaccination with Hexaxim as per a routine healthcare visit and according to approved local product labeling, at study centers (general hospitals or clinics located in Korea). The number of subjects to enroll per site (10 sites) will be defined with each investigator

Ages

2 to 6 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diphtheria prevention target hepatitis B virus infection prevention target pertussis prevention target poliomyelitis prevention target tetanus prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haemophilus influenzae type B immunisation Hepatitis B

Contacts and locations

Locations

  • Investigational Site Number : 001

    Seoul, South Korea

  • Investigational Site Number : 002

    Cheonan, South Korea

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Other studies related to the condition(s) this trial covers.