ImmunizationPhase 3NCT03188692
Safety and Efficacy of BK1310 Intramuscular Injection in Healthy Infants
A Phase 3 study testing DPT-IPV-Hib (Combined Vaccine) in people with Immunization, run by Tanabe Pharma Corporation at 3 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants. Read more about this study
- Who is it for?
- Ages 2 to 43 monthsHealthy volunteers can take part
- Conditions the study is for
- Immunization
- What is being tested?
- DPT-IPV-Hib (Combined Vaccine)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesJapan
- Study dates
- 23 Jun 2017to 9 Aug 2018
- 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 43 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). 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)
Who cannot join
- 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 diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents.
- With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
- With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.
Show all 12Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Investigational site 1
Chiba
Investigational site 2
Tokyo
Investigational site 3
Tokyo
About this study
Official title: Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants
The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.
- Conditions
- Immunization
- Being tested
- DPT-IPV-Hib (Combined Vaccine)
- Keywords
- Haemophilus influenza type b, Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivate, poliovirus combined vaccine, Hib, DPT-IPV, Intramuscular
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPT-IPV-Hib (Combined Vaccine)Biological
Also called BK1310
0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
| Study group | Role | What they receive |
|---|---|---|
| BK1310 | Experimental | Not described Receives: Biological: DPT-IPV-Hib (Combined Vaccine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (16)
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 primary immunization (Visit 4)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Measured: 4 weeks after the primary immunization (Visit 4)
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)
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)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Pertussis （PT）
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Pertussis （FHA）
Measured: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Tetanus Toxin
Measured: 4 weeks after the primary immunization (Visit 4)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Measured: Baseline and 4 weeks after the primary immunization (Visit 4)
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)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis （PT）
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis （FHA）
Measured: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Tetanus Toxin
Measured: 4 weeks after the booster dose (Visit 6)
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.
- First posted15 Jun 2017
- Study start23 Jun 2017
- Primary completion2 Nov 2017
- Study completion9 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ImmunizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Research Foundation for Microbial Diseases of Osaka University
- Responsible party
- Sponsor
- Investigators
- General Manager, Study director, Tanabe Pharma Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188692
- Sponsor's protocol ID
- BK1310-J02
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2017
- Last updated
- 6 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of BK1310 Intramuscular Injection in Healthy Infants
- ClinicalTrials.gov ID
- NCT03188692
- Acronym / sponsor ID
- BK1310-J02
- Conditions
- Immunization
- Keywords
- Haemophilus influenza type b, Adsorbed Diphtheria-Purified Pertussis-Tetanus-Inactivate, poliovirus combined vaccine, Hib, DPT-IPV, Intramuscular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Collaborators
- The Research Foundation for Microbial Diseases of Osaka University
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 9 Aug 2018 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Posted 3 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of an intramuscular injection of BK1310 in healthy infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BK1310 | Experimental | Biological: DPT-IPV-Hib (Combined Vaccine) |
Who may qualify
- Ages
- 2 to 43 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (12 listed)
- 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 diagnosis of thrombocytopenia and/or coagulopathy or currently under treatment of the antiplatelet agents and/or anticoagulant agents.
- With experience of Hib infection, diphtheria, pertussis, tetanus or acute poliomyelitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPT-IPV-Hib (Combined Vaccine)Also: BK13100.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months. | Biological | BK1310 |
Primary outcome
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)
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
16 secondary outcomes
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the primary immunization (Visit 4)
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer of Anti-PRP Antibody
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Pertussis （PT）
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Pertussis （FHA）
Time frame: 4 weeks after the primary immunization (Visit 4)
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the primary immunization (Visit 4)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: Baseline and 4 weeks after the primary immunization (Visit 4)
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
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Diphtheria Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis （PT）
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Pertussis （FHA）
Time frame: 4 weeks after the booster dose (Visit 6)
Geometric Mean Antibody Titer Against Tetanus Toxin
Time frame: 4 weeks after the booster dose (Visit 6)
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame: Baseline and 4 weeks after the primary immunization (Visit 6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
General Manager study director
Tanabe Pharma Corporation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DPT-IPV-Hib (Combined Vaccine) in people with Immunization, run by Tanabe Pharma Corporation at 3 sites 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 12 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 3 sites 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 3 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?
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.