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TetanusPhase 3NCT03891758

Confirmatory Study of BK1310 in Healthy Infants

A Phase 3 study testing DPT-IPV-Hib, Hib vaccine and DPT-IPV in people with Tetanus and Diphtheria, run by Tanabe Pharma Corporation at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants. Read more about this study

Who is it for?
Ages 2 to 42 monthsHealthy volunteers can take part
Conditions the study is for
Tetanus, Diphtheria, Pertussis
What is being tested?
DPT-IPV-Hib, Hib vaccine and DPT-IPV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
267 participants
Where
1 siteJapan
Study dates
1 Apr 2019to 10 Aug 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 42 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Investigational Site

    Fukuoka, Fukuoka

Other trials in Japan

About this study

Official title: Phase 3 Study of BK1310 Compared With ActHIB® and Tetrabik in Healthy Infants: A Randomized, Assessor-blind, Active-controlled

The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with co-administration of ActHIB® and Tetrabik, as well as efficacy and safety, in healthy infants.

Being tested
DPT-IPV-Hib, Hib vaccine, DPT-IPV
Keywords
Haemophilus influenza type b, Adsorbed Diphtheria-purified Pertussis-Tetanus- Inactivate poliovirus combined vaccine, Hib, DPT-IPV
Medical subject headings
Tetanus, Diphtheria, Whooping Cough, Poliomyelitis, Meningitis, Bacterial, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DPT-IPV-HibBiological

    Also called BK1310

    0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

  • Hib vaccineBiological

    Also called ActHIB®

    0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

  • DPT-IPVBiological

    Also called Tetrabik

    0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.

Study groups in NCT03891758
Study groupRoleWhat they receive
BK1310ExperimentalNot described
Receives: Biological: DPT-IPV-Hib
ActHIB® and TetrabikActive comparatorNot described
Receives: Biological: Hib vaccine; Biological: DPT-IPV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP

    Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: >=0.1 IU/mL, Anti-PT antibody concentrations: >=10.0 EU/mL, Anti-FHA antibody concentrations: >=10.0 EU/mL, Anti-tetanus antibody concentrations: >=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) >=8

    Measured: 4 weeks after the primary immunization (Visit 4)

Secondary outcomes (14)

  1. Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody

    Measured: 4weeks after the primary immunization (Visit 4)

  2. Geometric Mean Antibody Titer of Anti-PRP Antibody

    Measured: 4weeks after the primary immunization (Visit 4)

  3. Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody

    Measured: 4 weeks after the booster dose (Visit 6)

  4. Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody

    Measured: 4 weeks after the booster dose (Visit 6)

  5. Geometric Mean Antibody Titer of Anti-PRP Antibody

    Measured: 4 weeks after the booster dose (Visit 6)

  6. Geometric Mean Antibody Titer Against Diphtheria Toxin

    Measured: 4 weeks after the primary immunization (Visit 4)

  7. Geometric Mean Antibody Titer Against Pertussis

    Measured: 4 weeks after the primary immunization (Visit 4)

  8. Geometric Mean Antibody Titer Against Tetanus Toxin

    Measured: 4 weeks after the primary immunization (Visit 4)

  9. Geometric Mean Antibody Titer Against Polio Virus

    Measured: 4 weeks after the primary immunization (Visit 4)

  10. Antibody Prevalence Rate Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus

    Antibody prevalence rate is defined as the percentage of participants whose criteria of each antibody titer: Anti-diphtheria antibody concentrations: >=0.1 IU/mL, Anti-PT antibody concentrations: >=10.0 EU/mL, Anti-FHA antibody concentrations: >=10.0 EU/mL, Anti-tetanus antibody concentrations: >=0.01 IU/mL, Anti-poliovirus serotype 1,2 and 3 antibody titers (fold) >=8

    Measured: 4 weeks after the booster dose (Visit 6)

  11. Geometric Mean Antibody Titer Against Diphtheria Toxin

    Measured: 4 weeks after the booster dose (Visit 6)

  12. Geometric Mean Antibody Titer Against Pertussis

    Measured: 4 weeks after the booster dose (Visit 6)

  13. Geometric Mean Antibody Titer Against Tetanus Toxin

    Measured: 4 weeks after the booster dose (Visit 6)

  14. Fold Change in Geometric Mean Antibody Titer Against Polio Virus

    Measured: Baseline and 4 weeks after the primary immunization (Visit 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2019
  2. Study start1 Apr 2019
  3. Primary completion18 Sep 2019
  4. Study completion10 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
267 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03891758
Sponsor's protocol ID
BK1310-J03
Other IDs
jRCT2080224611
Status last verified
Dec 2025
First submitted
24 Mar 2019
Last updated
6 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Nakano T, Hasegawa M, Endo M, Matsuda K, Tamai H. Immunogenicity and safety of adsorbed diphtheria-purified pertussis-tetanus-inactivated polio (Sabin strain)-Haemophilus type b conjugate combined vaccine (DPT-IPV-Hib) in healthy Japanese Infants >/= 2 and < 43 months of Age: A phase III, multicenter, active controlled, assessor-blinded, randomized, parallel-group study. Vaccine. 2024 Apr 30;42(12):3134-3143. doi: 10.1016/j.vaccine.2023.03.077. Epub 2024 Apr 6.

    PubMed 38582691

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DPT-IPV-Hib, Hib vaccine and DPT-IPV in people with Tetanus and Diphtheria, run by Tanabe Pharma Corporation at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants With the Antibody Against Anti-PRP (time frame: 4 weeks after the primary immunization (Visit 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03891758, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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