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Could fewer shots protect just as well? new study tests hepatitis b vaccine schedules for babies

NCT ID NCT04294433

Vaccine Sponsor: Laval University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether giving young children 2 doses of the hepatitis B vaccine works as well as the usual 3 doses. Over 400 children aged 2 to 18 months took part. Researchers measured blood antibody levels to see if fewer shots still provide strong protection against the virus.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

431 people

The number who actually took part.

Started

Jun 2018

Finished

Dec 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 19 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B

Contacts and locations

Locations

  • Laval University Research Hospital Center

    Québec, Quebec, G1E7G9, Canada

  • Équipe de recherche en vaccination

    Québec, Quebec, G1E7G9, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.