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

NCT04294433 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2026-01-20

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

Infanrix-hexa

Vaccines administrated according to product monographs' recommendations

BIOLOGICAL

Infanrix-hexa and Twinrix Junior

Vaccines administrated according to product monographs' recommendations

Sponsors & Collaborators

  • Laval University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
19 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04294433 on ClinicalTrials.gov