Hepatitis BNCT06793826
Post-marketing Surveillance Study for the Safety of a DTaP-IPV- HB-PRP~T Vaccine in Republic of Korea
An observational study of Hepatitis B and Haemophilus Influenzae Type b Immunisation, run by Sanofi Pasteur, a Sanofi Company at 2 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 2 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Haemophilus Influenzae Type b Immunisation
- What is being tested?
- DTaP-IPV-Hep B-PRP-T combined vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 713 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 17 Jan 2025to 15 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 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
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Investigational Site Number : 002
Cheonan
Investigational Site Number : 001
Seoul
About this study
Official 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
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
Read the detailed description
The duration of each enrolled participant's participation in the study will be up to 36 or 43 days.
- Being tested
- DTaP-IPV-Hep B-PRP-T combined vaccine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP-IPV-Hep B-PRP-T combined vaccineBiological
Also called Hexaxim®
prefilled syringe injection intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Infants from 2 months of age vaccinated with 1 dose of Hexaxim on the day of enrollment Receives: Biological: DTaP-IPV-Hep B-PRP-T combined vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting immediate adverse events/adverse drug reactions (AEs/ADRs)
Unsolicited (spontaneously reported) systemic AEs/ADRs
Measured: Within 30 minutes post-vaccination
Number of participants reporting serious adverse events / adverse drug reactions (SAEs / SADRs)
SAEs and SADRs
Measured: Up to 43 days post-vaccination
Number of participants reporting solicited injection site and systemic reactions
Solicited injection site reactions: tenderness; erythema; site swelling Solicited systemic reactions: vomiting; crying abnormal; drowsiness; appetite loss; irritability
Measured: Up to 7 days post-vaccination
Number of participants reporting unsolicited non-serious AEs/ADRs
Unsolicited non-serious AEs and ADRs
Measured: Up to 28 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start17 Jan 2025
- Primary completion15 Jan 2026
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 713 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793826
- Sponsor's protocol ID
- A3L46
- Other IDs
- U1111-1266-4935
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2025
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06793826
- Acronym / sponsor ID
- A3L46
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 713 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The duration of each enrolled participant's participation in the study will be up to 36 or 43 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Biological: DTaP-IPV-Hep B-PRP-T combined vaccineInfants from 2 months of age vaccinated with 1 dose of Hexaxim on the day of enrollment |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 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
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DTaP-IPV-Hep B-PRP-T combined vaccineAlso: Hexaxim®prefilled syringe injection intramuscular | Biological | Cohort |
Primary outcome
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
Number of participants reporting serious adverse events / adverse drug reactions (SAEs / SADRs)
Time frame: Up to 43 days post-vaccination
SAEs and SADRs
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
Number of participants reporting unsolicited non-serious AEs/ADRs
Time frame: Up to 28 days post-vaccination
Unsolicited non-serious AEs and ADRs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Haemophilus Influenzae Type b Immunisation, run by Sanofi Pasteur, a Sanofi Company at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reporting immediate adverse events/adverse drug reactions (AEs/ADRs) (time frame: Within 30 minutes post-vaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.