Exploratory Clinical Study of MT-2301

Mitsubishi Tanabe Pharma

Status and phase

Completed

Phase 2

Conditions

Haemophilus Influenza Type b

Treatments

Biological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV

Biological: Haemophilus influenza type b conjugate vaccine + DPT-IPV

Biological: Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV

Study type

Interventional

Funder types

Industry

Identifiers

NCT02140047

MT-2301-J01

Details and patient eligibility

About

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.

Enrollment

154 patients

Sex

All

Ages

2 to 7 months old

Volunteers

Accepts Healthy Volunteers

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