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New combo vaccine for babies shows promise in large trial

NCT ID NCT02992925

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 370 healthy infants to see if it safely protects against several serious diseases: Hib, diphtheria, pertussis, tetanus, and polio. The vaccine was compared to existing vaccines. The goal was to check how well the infants' immune systems responded and if there were any side effects.

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

370 people

The number who actually took part.

Start date

Nov 2016

Finished

Nov 2018

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 43 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). Those who are applicable of the following conditions must be carefully observed before the enrollment: infants with known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, respiratory disease or developmental disorder. Infants who developed fever within 2 days after any previous vaccination. Infants with history of convulsions. * Written informed consent is obtained from a legal guardian (parent) Exclusion Criteria: * With past diagnosis of immunodeficiency or currently under immunosuppressive treatment * Have close relatives (the third degree of kinship) diagnosed with congenital immunodeficiency * 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. * Administered a live vaccine within 27 days before the first vaccination of the study drug, or inactivated vaccine or toxoid within 6 days before vaccination * Administered transfusion, immunosuppressant (excluding drugs for external use), or immunoglobulin formulation * Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs for external use) * Participated in other studies within 12 weeks before obtaining consent * With the gestational age \<37 weeks or weighed less than 2500 grams at birth. * Considered to be not eligible by the principal investigators (sub-investigators) of the enrollment.

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Conditions

The condition(s) this trial relates to.

Infections infectious disease diphtheria prevention target haemophilus infectious disease 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.

Immunization; infection

Contacts and locations

Locations

  • Study site

    Fukuoka, Fukuoka, Japan

  • Study site

    Kasuga-shi, Fukuoka, Japan

  • Study site

    Sendai, Miyagi, Japan

More trials for these conditions

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