Phase 2
Completed N=154
Exploratory Clinical Study of MT-2301
Haemophilus Influenza Type b
Source: ClinicalTrials.gov NCT02140047 ↗
Enrolled (actual)
154
Serious AEs
5.2%
Results posted
Sep 2024
Primary outcomePrimary: Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP — 100.0; 96.2; 94.0 percentage of participants
Summary
The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered with DPT-IPV using ActHIB® as a control in healthy infants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP |
100.0; 96.2; 94.0 | — |
| 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; 100.0 | — |
| SECONDARY Geometric Mean Antibody Titer of Anti-PRP Antibody |
65.086; 48.448; 39.752 | — |
| 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; 100.0; 100.0 | — |
| SECONDARY Geometric Mean Antibody Titer Against Diphtheria Toxin |
9.831; 10.102; 9.511 | — |
| SECONDARY Geometric Mean Antibody Titer Against Pertussis |
239.48; 233.12; 262.73; 124.84; 119.41; 158.85 | — |
| SECONDARY Geometric Mean Antibody Titer Against Tetanus Toxin |
1.750; 1.726; 2.051 | — |
| SECONDARY Fold Change in Geometric Mean Antibody Titer Against Polio Virus |
3479.6; 4544.8; 4685.1; 8360.7; 9908.9; 10642.5 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy infants aged ≥2 and <7 months at the first vaccination of the study drug
- Written informed consent is obtained from a legal guardian (parent)
Exclusion Criteria
- With obvious pyrexia (axillary temperature of 37.5ºC or higher) at vaccination of the study drug
- With known serious acute disease
- With known underlying disease such as cardiovascular disease, renal disease, hepatic disease, blood dyscrasia, and respiratory disease
- With past diagnosis of immunodeficiency or currently under immunosuppressive treatment
- History of anaphylaxis due to food or pharmaceuticals
- With experience of Hib infection, diphtheria, pertussis, tetanus, and acute poliomyelitis
- With experience of Hib vaccination, or administration of vaccine including either diphtheria, pertussis, tetanus, or polio as a constituent
- History of convulsions
- 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) continuously for more than 1 week
- Participated in other studies within 12 weeks before obtaining consent
Data sourced from ClinicalTrials.gov (NCT02140047). 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. Informational only — not medical advice.