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CompletedNCT03891758Updated Jan 6, 2026Results posted

Confirmatory Study of BK1310 in Healthy Infants

A Phase 3 interventional study of DPT-IPV-Hib and Hib vaccine in Tetanus, Diphtheria and Pertussis, sponsored by Tanabe Pharma Corporation. Completed at 1 site in Japan. Open to participants aged 2 Months to 42 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
267
Allocation
Randomized
Ages
2 Months to 42 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Tetanus
  • Diphtheria
  • Pertussis
  • Poliomyelitis
  • Bacterial Meningitis

Keywords

  • Haemophilus influenza type b
  • Adsorbed Diphtheria-purified Pertussis-Tetanus- Inactivate poliovirus combined vaccine
  • Hib
  • DPT-IPV
03

In context

Tetanus

318 studies on the registry are indexed under Tetanus; 29 are open to participants now.

This study's enrollment of 267 is below the median of 418 across 280 interventional studies indexed under Tetanus.

Browse Tetanus studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 92 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Browse Tanabe Pharma Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 42 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy infants aged ≥2 and \<43 months at the first vaccination of the study drug (recommended: ≥2 and \<7 months)
  • Written is obtained from a legal guardian (parent)

Exclusion criteria

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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
267 participants (actual)

Study arms

  • Experimental
    BK1310

    Biological: DPT-IPV-Hib

  • Active comparator
    ActHIB® and Tetrabik

    Biological: Hib vaccine · Biological: DPT-IPV

Interventions

  • BiologicalDPT-IPV-Hib

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

    Also known as: BK1310

  • BiologicalHib vaccine

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

    Also known as: ActHIB®

  • BiologicalDPT-IPV

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

    Also known as: Tetrabik

06

What researchers measure

Primary outcomes

  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

    Time frame: 4 weeks after the primary immunization (Visit 4)

Secondary outcomes

  1. 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: 4weeks after the primary immunization (Visit 4)

  2. Geometric Mean Antibody Titer of Anti-PRP Antibody

    Time frame: 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

    Time frame: 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

    Time frame: 4 weeks after the booster dose (Visit 6)

  5. Geometric Mean Antibody Titer of Anti-PRP Antibody

    Time frame: 4 weeks after the booster dose (Visit 6)

  6. Geometric Mean Antibody Titer Against Diphtheria Toxin

    Time frame: 4 weeks after the primary immunization (Visit 4)

  7. Geometric Mean Antibody Titer Against Pertussis

    Time frame: 4 weeks after the primary immunization (Visit 4)

  8. Geometric Mean Antibody Titer Against Tetanus Toxin

    Time frame: 4 weeks after the primary immunization (Visit 4)

  9. Geometric Mean Antibody Titer Against Polio Virus

    Time frame: 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

    Time frame: 4 weeks after the booster dose (Visit 6)

  11. Geometric Mean Antibody Titer Against Diphtheria Toxin

    Time frame: 4 weeks after the booster dose (Visit 6)

  12. Geometric Mean Antibody Titer Against Pertussis

    Time frame: 4 weeks after the booster dose (Visit 6)

  13. Geometric Mean Antibody Titer Against Tetanus Toxin

    Time frame: 4 weeks after the booster dose (Visit 6)

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

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

07

Results

Posted Jan 6, 2025

Participant flow

Participant flow — Overall Study
MilestoneBK1310ActHIB® and Tetrabik (Control)
Started133134
Completed131132
Not completed22
Withdrew: Adverse event20
Withdrew: Withdrawal by parent/guardian02

Outcome measures

PrimaryAntibody 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

Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Number · percentage of participants
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
percentage of participantsBK1310ActHIB® and Tetrabik (Control)
Antibody prevalence rate against anti-PRP with 1 μg/mL or higher100.0 (97.3 to 100.0)88.7 (82.1 to 93.5)
Antibody prevalence rate against diphtheria toxin99.2 (95.9 to 100.0)98.5 (94.7 to 99.8)
Antibody prevalence rate against pertussis （PT）100.0 (97.3 to 100.0)100.0 (97.3 to 100.0)
Antibody prevalence rate against pertussis (FHA)100.0 (97.3 to 100.0)100.0 (97.3 to 100.0)
Antibody prevalence rate against tetanus toxin100.0 (97.3 to 100.0)99.2 (95.9 to 100.0)
Antibody prevalence rate against polio virus serotype 1100.0 (97.2 to 100.0)100.0 (97.2 to 100.0)
Antibody prevalence rate against polio virus serotype 2100.0 (97.2 to 100.0)100.0 (97.2 to 100.0)
Antibody prevalence rate against polio virus serotype 3100.0 (97.2 to 100.0)100.0 (97.2 to 100.0)
SecondaryAnti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
Time frame:
4weeks after the primary immunization (Visit 4)
Reported as:
Number · percentage of participants
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
percentage of participantsBK1310ActHIB® and Tetrabik (Control)
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody100.0 (97.3 to 100.0)100.0 (97.3 to 100.0)
SecondaryGeometric Mean Antibody Titer of Anti-PRP Antibody
Time frame:
4weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · µg/mL
Geometric Mean Antibody Titer of Anti-PRP Antibody
µg/mLBK1310ActHIB® and Tetrabik (Control)
Geometric Mean Antibody Titer of Anti-PRP Antibody23.688 (20.208 to 27.768)6.698 (5.357 to 8.374)
SecondaryAnti-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)
Reported as:
Number · percentage of participants
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
percentage of participantsBK1310ActHIB® and Tetrabik (Control)
Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody100.0 (97.2 to 100.0)98.5 (94.6 to 99.8)
SecondaryAnti-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)
Reported as:
Number · percentage of participants
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
percentage of participantsBK1310ActHIB® and Tetrabik (Control)
Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody100.0 (97.2 to 100.0)100.0 (97.2 to 100.0)
SecondaryGeometric Mean Antibody Titer of Anti-PRP Antibody
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Geometric mean · µg/mL
Geometric Mean Antibody Titer of Anti-PRP Antibody
µg/mLBK1310ActHIB® and Tetrabik (Control)
Geometric Mean Antibody Titer of Anti-PRP Antibody56.545 (47.963 to 66.661)34.246 (28.835 to 40.672)
SecondaryGeometric Mean Antibody Titer Against Diphtheria Toxin
Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · IU/mL
Geometric Mean Antibody Titer Against Diphtheria Toxin
IU/mLBK1310ActHIB® and Tetrabik (Control)
Geometric Mean Antibody Titer Against Diphtheria Toxin1.841 (1.533 to 2.211)1.283 (1.050 to 1.567)
SecondaryGeometric Mean Antibody Titer Against Pertussis
Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · EU/mL
Geometric Mean Antibody Titer Against Pertussis
EU/mLBK1310ActHIB® and Tetrabik (Control)
pertussis （PT）155.30 (141.53 to 170.41)200.24 (183.42 to 218.61)
pertussis （FHA）56.48 (51.07 to 62.46)85.24 (76.96 to 94.40)
SecondaryGeometric Mean Antibody Titer Against Tetanus Toxin
Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · IU/mL
Geometric Mean Antibody Titer Against Tetanus Toxin
IU/mLBK1310ActHIB® and Tetrabik (Control)
Geometric Mean Antibody Titer Against Tetanus Toxin0.473 (0.408 to 0.548)0.158 (0.124 to 0.203)
SecondaryGeometric Mean Antibody Titer Against Polio Virus
Time frame:
4 weeks after the primary immunization (Visit 4)
Reported as:
Geometric mean · IU/mL
Geometric Mean Antibody Titer Against Polio Virus
IU/mLBK1310ActHIB® and Tetrabik (Control)
polio virus serotype 1684.95 (539.57 to 869.49)663.98 (512.66 to 859.96)
polio virus serotype 22026.44 (1733.39 to 2369.04)1767.97 (1498.47 to 2085.94)
polio virus serotype 31729.00 (1487.12 to 2010.23)2075.06 (1777.90 to 2421.90)
SecondaryAntibody 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

Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Number · percentage of participants
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
percentage of participantsBK1310ActHIB® and Tetrabik (Control)
Antibody prevalence rate against diphtheria toxin100.0 (97.2 to 100.0)100.0 (97.2 to 100.0)
Antibody prevalence rate against pertussis （PT）100.0 (97.2 to 100.0)100.0 (97.2 to 100.0)
Antibody prevalence rate against pertussis （FHA）100.0 (97.2 to 100.0)100.0 (97.2 to 100.0)
Antibody prevalence rate against tetanus toxin100.0 (97.2 to 100.0)99.2 (95.9 to 100.0)
Antibody prevalence rate against polio virus serotype 1100.0 (97.2 to 100.0)100.0 (97.2 to 100.0)
Antibody prevalence rate against polio virus serotype 2100.0 (97.2 to 100.0)100.0 (97.2 to 100.0)
Antibody prevalence rate against polio virus serotype 3100.0 (97.2 to 100.0)100.0 (97.2 to 100.0)
SecondaryGeometric Mean Antibody Titer Against Diphtheria Toxin
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Geometric mean · IU/mL
Geometric Mean Antibody Titer Against Diphtheria Toxin
IU/mLBK1310ActHIB® and Tetrabik (Control)
Geometric Mean Antibody Titer Against Diphtheria Toxin9.766 (8.758 to 10.890)8.961 (8.035 to 9.994)
SecondaryGeometric Mean Antibody Titer Against Pertussis
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Geometric mean · EU/mL
Geometric Mean Antibody Titer Against Pertussis
EU/mLBK1310ActHIB® and Tetrabik (Control)
Geometric mean antibody titer against pertussis （PT）209.05 (189.40 to 230.74)279.62 (254.28 to 307.49)
Geometric mean antibody titer against pertussis （FHA）144.73 (128.04 to 163.59)221.34 (194.79 to 251.51)
SecondaryGeometric Mean Antibody Titer Against Tetanus Toxin
Time frame:
4 weeks after the booster dose (Visit 6)
Reported as:
Geometric mean · IU/mL
Geometric Mean Antibody Titer Against Tetanus Toxin
IU/mLBK1310ActHIB® and Tetrabik (Control)
Geometric Mean Antibody Titer Against Tetanus Toxin1.904 (1.595 to 2.272)0.598 (0.457 to 0.783)
SecondaryFold Change in Geometric Mean Antibody Titer Against Polio Virus
Time frame:
Baseline and 4 weeks after the primary immunization (Visit 6)
Reported as:
Geometric mean · fold change
Fold Change in Geometric Mean Antibody Titer Against Polio Virus
fold changeBK1310ActHIB® and Tetrabik (Control)
Geometric mean antibody titer against polio virus serotype 12524.05 (2110.26 to 3018.98)2662.91 (2254.04 to 3145.95)
Geometric mean antibody titer against polio virus serotype 28821.88 (7678.48 to 10135.54)7512.10 (6425.09 to 8783.01)
Geometric mean antibody titer against polio virus serotype 36439.23 (5472.88 to 7576.21)7355.96 (6324.16 to 8556.09)

Adverse events

Collected over Through study completion, an average of 1 year. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BK13100/133 (0%)9/133 (6.8%)131/133 (98.5%)
ActHIB® and Tetrabik (Control)0/134 (0%)11/134 (8.2%)132/134 (98.5%)
Most frequent serious events
Showing 10 of 15
Most frequent serious events
EventBK1310ActHIB® and Tetrabik (Control)
Kawasaki's diseaseVascular disorders3/1330/134
Respiratory syncytial virus infectionInfections and infestations0/1333/134
Febrile convulsionNervous system disorders1/1332/134
Adenovirus infectionInfections and infestations1/1331/134
Enterocolitis bacterialInfections and infestations1/1330/134
Respiratory syncytial virus bronchiolitisInfections and infestations1/1330/134
Urinary tract infectionInfections and infestations1/1330/134
Fractured skull depressedInjury, poisoning and procedural complications1/1330/134
AsthmaRespiratory, thoracic and mediastinal disorders1/1331/134
Cholangiectasis congenitalCongenital, familial and genetic disorders0/1331/134
Most frequent other events
Showing 10 of 21
Most frequent other events
EventBK1310ActHIB® and Tetrabik (Control)
Injection site erythemaGeneral disorders105/133107/134
PyrexiaGeneral disorders91/13388/134
Injection site indurationGeneral disorders63/13372/134
Injection site swellingGeneral disorders41/13347/134
Irritability postvaccinalGeneral disorders40/13346/134
NasopharyngitisInfections and infestations39/13338/134
CryingGeneral disorders37/13338/134
HypersomniaNervous system disorders36/13331/134
InsomniaPsychiatric disorders24/13328/134
Injection site painGeneral disorders18/13326/134

Baseline characteristics

Excluding 1 subject(control: 1 subject) whose all antibody titers could not be measured at Visit 4

Age, Customized
Age, Customized(Participants)BK1310ActHIB® and Tetrabik (Control)Total
>=2 and <3 months124125249
>=3 months9817
Sex: Female, Male
Sex: Female, Male(Participants)BK1310ActHIB® and Tetrabik (Control)Total
Female7362135
Male6071131
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)BK1310ActHIB® and Tetrabik (Control)Total
Asian (Japanese)133133266
08

Study locations

1 site
  • Investigational Site
    Fukuoka, Fukuoka, Japan
09

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03891758
Lead sponsor
Tanabe Pharma Corporation
Collaborators
The Research Foundation for Microbial Diseases of Osaka University
Responsible party
Sponsor
First posted
Mar 27, 2019
Start date
Apr 1, 2019
Primary completion
Sep 18, 2019
Completion
Aug 10, 2020
Results posted
Jan 6, 2025
Last update
Jan 6, 2026

Study contacts

General Manager
study director · Tanabe Pharma Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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