Phase III study of intramuscular TAK-816 in healthy infants
- Conditions
- Prevention of infections caused by Haemophilus influenzae type b
- Registration Number
- JPRN-jRCT2080222404
- Lead Sponsor
- TAKEDA PHARMACEUTICAL COMPANY LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 30
1.Healthy Japanese infants
2.Male or female infants aged 2-6 months (>=2 and <7 months) at the time of the first dose of investigational product (excluding hospitalized infants)
3.Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.
1. Any serious acute illness.
2. Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder.
3. History of possible Haemophilus influenzae type b (Hib) infection.
4. Previously diagnosed immunodeficiency.
5. Documented history of anaphylaxis to any ingredients of the investigational product (e.g., diphtheria toxoid)
6. A history of convulsions.
7. Previous administration of another Hib vaccine.
8. Treatment with any live vaccine during the 27 days before the first dose of TAK-816 or with any inactivated vaccine during the 6 days before dosing.
9. Prior participation in any clinical study or post-marketing clinical study
10. Previously receipt of blood transfusions, gamma globulin preparations (except monoclonal vaccines as antigens), systemic immunosuppressive therapy, or systemic corticosteroids, or a plan to receive any of these products during the study period
11. Presence of thrombocytopenia or coagulopathy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety: Adverse events, body temperature and health diaries<br>Primary timeframeFor 64 weeks<br>Treatment emergent adverse events (TEAEs), defined as events that first occur or worsen in intensity after the start of administration of the investigational product, will be summarized by System Organ Class (SOC) and Preferred Term (PT) using frequency distributions for each of the following: <br>- All TEAEs<br>- TEAEs by severity <br>- TEAEs by onset<br>- TEAEs that are possibly related to the investigational product<br>- TEAEs that are possibly related to the investigational product by severity<br>- TEAEs that led to the discontinuation of study vaccination <br>- Serious TEAEs<br>For body temperature, summary statistics of baseline values and observed values at each time point of evaluation will be calculated. <br>On the basis of health diary entries, local and systemic reactions will be summarized using frequency distributions.
- Secondary Outcome Measures
Name Time Method