Haemophilus Influenza Type b Clinical Trial
Official title:
Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)
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.
| Status | Completed |
| Enrollment | 157 |
| Est. completion date | September 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 2 Months to 7 Months |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Japan | Investigational site | Fukuoka-shi | Fukuoka |
| Lead Sponsor | Collaborator |
|---|---|
| Mitsubishi Tanabe Pharma Corporation |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Anti-PRP antibody prevalence rate with 1 µg/mL or higher | 4 weeks after the primary immunization (Visit 4) | No | |
| Secondary | Anti-PRP antibody prevalence rate with 0.15 µg/mL or higher | 4 weeks after the primary immunization (Visit 4) | No | |
| Secondary | Geometric mean antibody titer (GMT) of anti-PRP antibody | 4 weeks after the primary immunization (Visit 4) | No | |
| Secondary | Anti-PRP antibody prevalence rate with 1 µg/mL or higher | 4 weeks after the booster dose (Visit 6) | No | |
| Secondary | Anti-PRP antibody prevalence rate with 0.15 µg/mL or higher | 4 weeks after the booster dose (Visit 6) | No | |
| Secondary | Geometric mean antibody titer (GMT) of anti-PRP antibody | 4 weeks after the booster dose (Visit 6) | No | |
| Secondary | Antibody prevalence rate and geometric mean antibody titer (GMT) against diphtheria toxin, pertussis, tetanus toxin, and less virulent strain of polio virus | 4 weeks after the primary immunization (Visit 4) | No | |
| Secondary | Antibody prevalence rate and geometric mean antibody titer (GMT) against diphtheria toxin, pertussis, tetanus toxin, and less virulent strain of polio virus | 4 weeks after the booster dose (Visit 6) | No | |
| Secondary | Adverse events and adverse reactions | through the first dose (Visit 1) to 4 weeks after the booster dose (Visit 6) | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT02257645 -
Post-authorization Safety Study of Euforvac-Hib Vaccine for Active Primary Immunization in Infants From 6 Weeks
|
N/A |