NCT04294433CompletedPhase 4
Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children
Clinical Trial to Assess Immunogenicity of 2 Versus 3 Doses of Hepatitis B Vaccines When Administered to Children Aged 2 to 18 Months
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 431 (actual)
- First submitted
- 29 Jan 2020
- Start date
- 11 Jun 2018
- Primary completion date
- 30 Dec 2023
- Lead sponsor
- Laval University
- Diseases
- Hepatitis B
- NCT number
- NCT04294433
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 431
- From 11 Jun 2018 to the primary completion date, 30 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received other doses of hepatitis B vaccine;
Other illness
- 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.
Other
- Considered immunosuppressed;
Who the study is looking for
- 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.
Age in the registry: 2 months to 19 months · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Laval University Research Hospital Center Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Équipe de recherche en vaccination Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.