Clinical Trial: Exploratory Clinical Study of MT-2301
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Exploratory Clinical Study of MT-2301 in Healthy Infants (Phase 2)
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.
Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation
Current Primary Outcome: Anti-PRP antibody prevalence rate with 1 μg/mL or higher [ Time Frame: 4 weeks after the primary immunization (Visit 4) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher [ Time Frame: 4 weeks after the primary immunization (Visit 4) ]
- Geometric mean antibody titer (GMT) of anti-PRP antibody [ Time Frame: 4 weeks after the primary immunization (Visit 4) ]
- Anti-PRP antibody prevalence rate with 1 μg/mL or higher [ Time Frame: 4 weeks after the booster dose (Visit 6) ]
- Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher [ Time Frame: 4 weeks after the booster dose (Visit 6) ]
- Geometric mean antibody titer (GMT) of anti-PRP antibody [ Time Frame: 4 weeks after the booster dose (Visit 6) ]
- Antibody prevalence rate and geometric mean antibody titer (GMT) against diphtheria toxin, pertussis, tetanus toxin, and less virulent strain of polio virus [ Time Frame: 4 weeks after the primary immunization (Visit 4) ]
- Antibody prevalence rate and geometric mean antibody titer (GMT) against diphtheria toxin, pertussis, tetanus toxin, and less virulent strain of polio virus [ Time Frame: 4 weeks after the booster dose (Visit 6) ]
- Adverse events and adverse reactions [ Time Frame: through the first dose (Visit 1) to 4 weeks after the booster dose (Visit 6) ]
Original Secondary Outcome: Same as current
Information By: Mitsubishi Tanabe Pharma Corporation
Dates:
Date Received: May 14, 2014
Date Started: April 2014
Date Completion:
Last Updated: October 15, 2015
Last Verified: October 2015