NCT04294433

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2018

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5.6 years

First QC Date

January 29, 2020

Last Update Submit

January 14, 2026

Conditions

Hepatitis B

Keywords

VaccinationTwo dosesInfantsClinical trialHepatitis BHeterologous scheduleImmunogenicityRandomizationReduced-dose schedule

Outcome Measures

Primary Outcomes (2)

  • Immunogenicity - Seroprotection

    The proportion of children with an anti-HBs titer ≥10mIU/ml

    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

    1 month after a challenge dose administered 36 months after the end of the primary series

Study Arms (3)

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

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

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

Biological: Infanrix-hexa and Twinrix Junior

Interventions

Infanrix-hexaBIOLOGICAL

Vaccines administrated according to product monographs' recommendations

Infanrix-hexa+Infanrix-hexaInfanrix-hexa+Infanrix-hexa+Infanrix-hexa
Infanrix-hexa and Twinrix JuniorBIOLOGICAL

Vaccines administrated according to product monographs' recommendations

Infanrix-hexa+Twinrix Junior

Eligibility Criteria

Age2 Months - 19 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Laval University Research Hospital Center

Québec, Quebec, G1E7G9, Canada

Location

Équipe de recherche en vaccination

Québec, Quebec, G1E7G9, Canada

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomised 1:1 for 2 study groups. Non-randomised for comparator group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2020

First Posted

March 4, 2020

Study Start

June 11, 2018

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

No individual data will be shared with any other researchers outside of this study

Locations

CA(2)