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New combo vaccine shows promise in protecting infants from five serious diseases

NCT ID NCT03891758

Vaccine Sponsor: Tanabe Pharma Corporation 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new vaccine called BK1310 in 267 healthy infants to see if it protects against tetanus, diphtheria, pertussis, polio, and bacterial meningitis as well as existing vaccines. Infants received three doses, and researchers measured their immune responses. The goal was to confirm the new vaccine is safe and effective for routine infant immunization.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

267 people

The number who actually took part.

Started

Apr 2019

Finished

Aug 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

2 to 42 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: * Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months) * Written informed consent is obtained from a legal guardian (parent) Exclusion Criteria: * Possibility of anaphylaxis due to food or pharmaceuticals * With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis * With experience of Hib, diphteria, pertussis, tetanus or polio vaccination. * Participated in other studies within 12 weeks before obtaining consent * Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment Additional screening criteria check may apply for qualification.

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Conditions

The condition(s) this trial relates to.

bacterial meningitis haemophilus infectious disease diphtheria prevention target haemophilus meningitis prevention target pertussis prevention target poliomyelitis prevention target tetanus prevention target

As listed by the trial registrant

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

Bacterial meningitis Diphtheria Pertussis Poliomyelitis Tetanus

Contacts and locations

Locations

  • Investigational Site

    Fukuoka, Fukuoka, Japan

More trials for these conditions

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