drugset / Trial / NCT04294433

Immunogenicity of 2 Versus 3 Doses of Combined Hepatitis B Vaccines in 2-18 Months Old Children

NCT04294433

Phase 4 Completed 431 enrolled Laval University
RandomizedParallel-groupOpen-labelPrevention

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).

Timeline

Start
2018-06-11
Primary completion
2023-12-30
Completion
2023-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Infanrix hexa Vaccine
Subject Twinrix™ Junior Vaccine