Clinical trial NCT02140047: Exploratory Clinical Study of MT-2301
Official title: Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Haemophilus Influenza Type b
Keywords: Haemophilus influenza type b
Hib
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-16
Enrollment: 154
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


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

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer of Anti-PRP Antibody
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Anti-PRP Antibody Prevalence Rate With 1 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Anti-PRP Antibody Prevalence Rate With 0.15 μg/mL or Higher, Defined as the Percentage of Participants With the Anti-PRP Antibody
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer of Anti-PRP Antibody
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Diphtheria Toxin
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer Against Pertussis
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer Against Tetanus Toxin
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Fold Change in Geometric Mean Antibody Titer Against Polio Virus
timeFrame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric Mean Antibody Titer Against Diphtheria Toxin
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Pertussis
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Geometric Mean Antibody Titer Against Tetanus Toxin
timeFrame: 4 weeks after the booster dose (Visit 6)
measure: Fold Change in Geometric Mean Antibody Titer Against Polio Virus
timeFrame: 4 weeks after the booster dose (Visit 6)
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Investigational site
state: Fukuoka
Study officials:
affiliation: Department of pediatrics, Kawasaki Hospital, Kawasaki Medical School
name: Takashi Nakano, M.D., Ph.D.
role: STUDY_DIRECTOR
References: