Hepatitis BPhase 4NCT04294433
Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children
A Phase 4 study testing Infanrix-hexa and Infanrix-hexa and Twinrix Junior in people with Hepatitis B, run by Laval University at 2 sites in Canada.
Trial summary
The main objective of this study is to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III)… Read more about this study
- Who is it for?
- Ages 2 to 19 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Infanrix-hexa and Infanrix-hexa and Twinrix Junior
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 431 participants
- Where
- 2 sitesCanada
- Study dates
- 11 Jun 2018to 30 Dec 2023
- Phase
- Phase 4
- 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 19 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Comparator group :
- Have received 3 doses of Infanrix-hexa as part of the regular vaccination program at the age of 2, 4 and 18 months.
- Study groups:
- Have received 1 dose of Infanrix-hexa as part of the regular vaccination program at the age of 2 months.
Who cannot join
- Have received other doses of hepatitis B vaccine;
- Considered immunosuppressed;
- Have an autoimmune disease;
- Have contraindications to HBV vaccination, as defined in the Quebec Immunization Protocol;
- Have a bleeding disorder;
- Have a significant developmental delay;
- Have or plan to participate in other clinical studies with vaccines or products not licensed in Canada;
- Have presented a serious clinical condition to the vaccines administered as part of the study.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Laval University Research Hospital Center
Québec, Quebec, G1E7G9
Équipe de recherche en vaccination
Québec, Quebec, G1E7G9
About this study
Official title: Clinical Trial to Assess Immunogenicity of 2 Versus 3 Doses of Hepatitis B Vaccines When Administered to Children Aged 2 to 18 Months
The main objective of this study is to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).
Read the detailed description
In the province of Quebec, Canada, hepatitis B vaccination of infants involves three doses of vaccine, 2, 4 and 18 months of age. However, in the current epidemiological context (virtual absence of new cases in young Quebecers) and taking into account scientific data which consistently show a high immunogenicity and efficacy of two doses of hepatitis B vaccine, the relevance of the second dose given at the age of 4 months is questionable.
this study is designed to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).
- Conditions
- Hepatitis B
- Being tested
- Infanrix-hexa, Infanrix-hexa and Twinrix Junior
- Keywords
- Vaccination, Two doses, Infants, Clinical trial, Hepatitis B, Heterologous schedule, Immunogenicity, Randomization, Reduced-dose schedule
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infanrix-hexaBiological
Vaccines administrated according to product monographs' recommendations
Infanrix-hexa and Twinrix JuniorBiological
Vaccines administrated according to product monographs' recommendations
| Study group | Role | What they receive |
|---|---|---|
| Infanrix-hexa+Infanrix-hexa+Infanrix-hexa | Active comparator | Children vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa Receives: Biological: Infanrix-hexa |
| Infanrix-hexa+Infanrix-hexa | Experimental | Children vaccinated at the age of 2 and 12 months with a standard dose of Infanrix-hexa Receives: Biological: Infanrix-hexa |
| Infanrix-hexa+Twinrix Junior | Experimental | Children vaccinated at the age of 2 and 12 months with a standard dose of Infanrix-hexa and a standard dose of Infanrix-Junior, respectively Receives: Biological: Infanrix-hexa and Twinrix Junior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity - Seroprotection
The proportion of children with an anti-HBs titer ≥10mIU/ml
Measured: 1 month after the primary series
Immune memory - Anamnestic response
Immune response to a challenge dose: anti-HBs titers at least 10 mIU/mL and a fourfold increase in titers
Measured: 1 month after a challenge dose administered 36 months after the end of the primary series
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start11 Jun 2018
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
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 Laval UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised 1:1 for 2 study groups. Non-randomised for comparator group.
- Masking
- None (open label)
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294433
- Sponsor's protocol ID
- Study 11022017
- Status last verified
- Jan 2026
- First submitted
- 29 Jan 2020
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data will be shared with any other researchers outside of this study
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess Immunogenicity of 2 Versus 3 Doses of Hepatitis B Vaccines When Administered to Children Aged 2 to 18 Months
- ClinicalTrials.gov ID
- NCT04294433
- Acronym / sponsor ID
- Study 11022017
- Conditions
- Hepatitis B
- Keywords
- Vaccination, Two doses, Infants, Clinical trial, Hepatitis B, Heterologous schedule, Immunogenicity, Randomization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 4 Mar 2020 (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.
The main objective of this study is to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).
Detailed description
In the province of Quebec, Canada, hepatitis B vaccination of infants involves three doses of vaccine, 2, 4 and 18 months of age. However, in the current epidemiological context (virtual absence of new cases in young Quebecers) and taking into account scientific data which consistently show a high immunogenicity and efficacy of two doses of hepatitis B vaccine, the relevance of the second dose given at the age of 4 months is questionable.
this study is designed to compare the immunogenicity of the hepatitis B component in children vaccinated with (I) two doses of Infanrix-hexa administered at 2 and 12 months of age versus (II) one dose of Infanrix-hexa and one dose of Twinrix administered respectively at 2 and 12 months of age versus (III) three doses of Infanrix-hexa administered at 2, 4 and 18 months of age (comparator).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomised 1:1 for 2 study groups. Non-randomised for comparator group.
| Arm | Type | Receives |
|---|---|---|
| Infanrix-hexa+Infanrix-hexa+Infanrix-hexa | Active comparator | Biological: Infanrix-hexaChildren vaccinated at the age of 2, 4 and 18 months with a standard dose of Infanrix-hexa |
| Infanrix-hexa+Infanrix-hexa | Experimental | Biological: Infanrix-hexaChildren vaccinated at the age of 2 and 12 months with a standard dose of Infanrix-hexa |
| Infanrix-hexa+Twinrix Junior | Experimental | Biological: Infanrix-hexa and Twinrix JuniorChildren vaccinated at the age of 2 and 12 months with a standard dose of Infanrix-hexa and a standard dose of Infanrix-Junior, respectively |
Who may qualify
- Ages
- 2 to 19 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Comparator group :
- Have received 3 doses of Infanrix-hexa as part of the regular vaccination program at the age of 2, 4 and 18 months.
- Study groups:
- Have received 1 dose of Infanrix-hexa as part of the regular vaccination program at the age of 2 months.
Key exclusion criteria (8 listed)
- Have received other doses of hepatitis B vaccine;
- Considered immunosuppressed;
- Have an autoimmune disease;
- Have contraindications to HBV vaccination, as defined in the Quebec Immunization Protocol;
- Have a bleeding disorder;
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 |
|---|---|---|
| Infanrix-hexaVaccines administrated according to product monographs' recommendations | Biological | Infanrix-hexa+Infanrix-hexa, Infanrix-hexa+Infanrix-hexa+Infanrix-hexa |
| Infanrix-hexa and Twinrix JuniorVaccines administrated according to product monographs' recommendations | Biological | Infanrix-hexa+Twinrix Junior |
Primary outcome
Immunogenicity - Seroprotection
Time frame: 1 month after the primary series
The proportion of children with an anti-HBs titer ≥10mIU/ml
Immune memory - Anamnestic response
Time frame: 1 month after a challenge dose administered 36 months after the end of the primary series
Immune response to a challenge dose: anti-HBs titers at least 10 mIU/mL and a fourfold increase in titers
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 20 Jan 2026.
- Individual participant dataSharing planned: No. No individual data will be shared with any other researchers outside of this study
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infanrix-hexa and Infanrix-hexa and Twinrix Junior in people with Hepatitis B, run by Laval University at 2 sites in Canada.
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 4 inclusion and 8 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 20 Jan 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Immunogenicity - Seroprotection (time frame: 1 month after the primary series). The study lists 2 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 20 Jan 2026.