Trials / Completed
CompletedNCT04294433
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 431 (actual)
- Sponsor
- Laval University · Academic / Other
- Sex
- All
- Age
- 2 Months – 19 Months
- Healthy volunteers
- Accepted
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) 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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Infanrix-hexa | Vaccines administrated according to product monographs' recommendations |
| BIOLOGICAL | Infanrix-hexa and Twinrix Junior | Vaccines administrated according to product monographs' recommendations |
Timeline
- Start date
- 2018-06-11
- Primary completion
- 2023-12-30
- Completion
- 2023-12-30
- First posted
- 2020-03-04
- Last updated
- 2026-01-20
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT04294433. Inclusion in this directory is not an endorsement.