Exploratory Clinical Study of MT-2301 (NCT02140047) | Clinical Trial Compass
CompletedPhase 2
Exploratory Clinical Study of MT-2301
Japan154 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range2 Months – 7 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Antibody Against Anti-PRP
Timeframe: 4 weeks after the primary immunization (Visit 4)