Phase 3
N=267
Confirmatory Study of BK1310 in Healthy Infants
Tetanus · Diphtheria · Pertussis · Poliomyelitis · Bacterial Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT03891758 ↗Enrolled (actual)
267
Serious AEs
7.5%
Results posted
Jan 2025
Primary outcome: Primary: 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 — 100.0; 88.7; 99.2; 98.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- DPT-IPV-Hib (Biological); Hib vaccine (Biological); DPT-IPV (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
100.0; 88.7; 99.2; 98.5; 100.0; 100.0 | — |
| SECONDARY Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody |
100.0; 100.0 | — |
| SECONDARY Geometric Mean Antibody Titer of Anti-PRP Antibody |
56.545; 34.246 | — |
| SECONDARY Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody |
100.0; 98.5 | — |
| SECONDARY Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody |
100.0; 100.0 | — |
| SECONDARY Geometric Mean Antibody Titer of Anti-PRP Antibody |
56.545; 34.246 | — |
| SECONDARY Geometric Mean Antibody Titer Against Diphtheria Toxin |
9.766; 8.961 | — |
| SECONDARY Geometric Mean Antibody Titer Against Pertussis |
209.05; 279.62; 144.73; 221.34 | — |
| SECONDARY Geometric Mean Antibody Titer Against Tetanus Toxin |
1.904; 0.598 | — |
| SECONDARY Geometric Mean Antibody Titer Against Polio Virus |
684.95; 663.98; 2026.44; 1767.97; 1729.00; 2075.06 | — |
| SECONDARY 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 |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Geometric Mean Antibody Titer Against Diphtheria Toxin |
9.766; 8.961 | — |
| SECONDARY Geometric Mean Antibody Titer Against Pertussis |
209.05; 279.62; 144.73; 221.34 | — |
| SECONDARY Geometric Mean Antibody Titer Against Tetanus Toxin |
1.904; 0.598 | — |
| SECONDARY Fold Change in Geometric Mean Antibody Titer Against Polio Virus |
2524.05; 2662.91; 8821.88; 7512.10; 6439.23; 7355.96 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
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.
Data sourced from ClinicalTrials.gov (NCT03891758). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.