Cure My Disease

Don't miss your cure!

 Log in / Sign up

One shot, six protections: can a new vaccine match current standards?

NCT ID NCT07793513

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This phase 3 trial tests a new combination vaccine called BK1803 in healthy infants aged 2 to 7 months. The vaccine aims to protect against six diseases: whooping cough, diphtheria, tetanus, polio, hepatitis B, and Haemophilus influenzae type b. Researchers compare BK1803 to a standard vaccine regimen to see if it triggers similar antibody responses and is equally safe. If successful, BK1803 could simplify infant vaccination schedules.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BK1803, a combination vaccine that protects against pertussis, diphtheria, tetanus, polio, hepatitis B, and Haemophilus influenzae type b
What this could lead to
If it works, BK1803 could offer infants protection against six serious diseases in fewer shots, simplifying vaccination schedules.
What could go wrong
This is a phase 3 trial, so earlier stages have passed, but success is not guaranteed. The vaccine may not trigger strong enough immune responses or may cause side effects like fever or injection-site reactions.

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

About 344 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Apr 2029

An estimate. End dates often move.

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 6 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: Subjects meeting all of the following inclusion criteria at the time of the first vaccination with the study drug will be eligible for study participation. 1. Japanese healthy infants aged \>= 2 months and \< 7 months at the time of the first vaccination with the study drug. However, although subjects meeting the following definition of "subjects who should receive a vaccination with care" may participate in the study, whether or not to enroll them in the study should be decided carefully by the (sub)investigator. 2. Subjects from whose legal guardians (persons with parental rights) written consent to study participation has been obtained. Subjects Who Should Receive A Vaccination With Care 4) applies only to the Main Cohort. 1. Subjects who clearly have underlying diseases, such as cardiovascular disease, kidney disease, liver disease, blood disease, respiratory disease, or a developmental disorder 2. Subjects who have developed a pyrexia within 2 days after receiving a vaccination in the past 3. Subjects with a past history of convulsions 4. (Main Cohort only) Subjects with the gestational age \<37 weeks, or who weighed less than 2500 g at birth Exclusion Criteria: Subjects meeting any of the following exclusion criteria at the time of the first vaccination with the study drug will be excluded from study participation. However, (15) applies only to the Safety Lead-in Cohort. 1. Subjects who have received diagnoses of immunodeficiencies in the past, or who are currently receiving treatments that cause immunosuppression 2. Subjects with close relatives (up to third degree of kinship) who have a congenital immunodeficiency 3. Subjects who might experience a serious allergy in response to a food, drug product (especially any component of the study drug), etc. 4. Subjects who have had Haemophilus Influenzae type b (Hib) infections, pertussis, diphtheria, tetanus, acute poliomyelitis, or hepatitis B in the past 5. Subjects who have received a vaccination against Hib, pertussis, diphtheria, tetanus, polio, or hepatitis B in the past 6. Subjects who have received hepatitis B immunoglobulin (HBIG) for the prevention of vertical infection in the past 7. Subjects who were born to a mother who had received a vaccination against Hib, pertussis, diphtheria, tetanus, polio, or hepatitis B (including a combination vaccine such as diphtheria-pertussis-tetanus vaccine) during pregnancy 8. Subjects who are receiving anticoagulant therapy or who have thrombocytopenia or coagulation disorder 9. Subjects with fibrodysplasia ossificans progressiva 10. Subjects who have received live vaccines within 27 days before the first vaccination with the study drug 11. Subjects who have received inactivated vaccines/toxoids or mRNA vaccines within 6 days before the first vaccination with the study drug 12. Subjects who have received blood transfusions, immunosuppressants (except for topical drugs), or immunoglobulin preparations in the past 13. Subjects who have received corticosteroids (except for topical drugs) at a prednisolone dose level equivalent of 2 mg/kg/day or higher in the past 14. Subjects who have participated in another clinical study and received another study drug within 12 weeks before obtaining informed consent 15. (Safety Lead-in Cohort only) Subjects with the gestational age \<37 weeks, or who weighed less than 2500 g at birth 16. Subjects otherwise judged to be unsuitable for participation in this study by the (sub)investigator

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Diphtheria are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

haemophilus infectious disease diphtheria prevention target hepatitis B virus infection 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.

Diphtheria Haemophilus influenzae type B Hepatitis B Pertussis Poliomyelitis Tetanus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aiwa Hospital

    Kawagoe-shi, Saitama, 350-0001, Japan

  • Aizenbashi Hospital

    Osaka, Osaka, 556-0005, Japan

  • Aquakids Clinic

    Edogawa-Ku, Tokyo, 133-0056, Japan

  • Arakawa Family Clinic

    Nagano, Nagano, 381-0025, Japan

  • Araki Children Clinic

    Sapporo, Hokkaido, 006-0814, Japan

  • Asama General Hospital

    Saku, Nagano, 385-8558, Japan

  • Fukui Aiiku Hospital

    Fukui-shi, Fukui, 910-0833, Japan

  • Hamami Kodomo Clinic

    Chigasaki, Kanagawa, 253-0062, Japan

  • Hara Children's Clinic

    Tokorozawa, Saitama, 359-1141, Japan

  • Hibarigaoka Kodomo Clinic

    Sapporo, Hokkaido, 004-0052, Japan

  • Ina Central Hospital

    Ina-shi, Nagano, 396-8555, Japan

  • Isesaki Municipal Hospital

    Isesaki, Gunma, 372-0817, Japan

  • Ishikari Kids Clinic

    Ishikari-shi, Hokkaido, 061-3202, Japan

  • JISENKAI Healthcare Incorporated Foundation, Aizawa Hospital

    Matsumoto, Nagano, 390-8510, Japan

  • Japan Community Healthcare Organization Hokkaido Hospital

    Sapporo, Hokkaido, 062-8618, Japan

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka, Fukuoka, 815-8555, Japan

  • Japanese Red Cross Maebashi Hospital

    Maebashi, Gunma, 371-0811, Japan

  • Karugamo Clinic

    Setagaya-Ku, Tokyo, 156-0054, Japan

  • Kawasaki Municipal Hospital

    Kawasaki-shi, Kanagawa, 210-0013, Japan

  • Kochi Health Sciences Center

    Kochi, Kochi, 781-8555, Japan

  • Kumagai Children's Clinic

    Amagasaki, Hyōgo, 661-0953, Japan

  • Kurokawa Michiko Pediatric Clinic

    Fukuoka, Fukuoka, 815-0033, Japan

  • Medical Corporation Asbo Tokyo Asbo Clinic

    Chuo-ku, Tokyo, 104-0031, Japan

  • Morooka Chirdren's Chikushi-dori Clinic

    Fukuoka, Fukuoka, 812-0894, Japan

  • Nara Prefecture General Medical Center

    Nara, Nara, 630-8581, Japan

  • Oda Children's Allergy Clinic

    Fukuoka, Fukuoka, 810-0022, Japan

  • Okawa Children & Family Clinic

    Ōta-ku, Tokyo, 146-0095, Japan

  • Sagamihara Kyodo Hospital

    Sagamihara, Kanagawa, 252-5188, Japan

  • Sakuranbo Kodomo Clinic

    Kumamoto, Kumamoto, 862-0924, Japan

  • Shindo children's clinic

    Fukuoka, Fukuoka, 814-0121, Japan

  • Taniguchi Children Clinic

    Hiroshima, Hiroshima, 732-0023, Japan

  • Yaizu City Hospital

    Yaizu, Shizuoka, 425-8505, Japan

  • Yoshimitsu Pediatric Clinic

    Hiroshima, Hiroshima, 731-0124, Japan

More trials for these conditions

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