Prevention of infections caused by Haemophilus influenzae type b
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-816
INN of investigational material :
Therapeutic category code : 631 Vaccines
Dosage and Administration for Investigational material : Primary immu
Sponsors
TAKEDA PHARMACEUTICAL COMPANY LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Adverse events, body temperature and health diaries Primary timeframeFor 64 weeks 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: - All TEAEs - TEAEs by severity - TEAEs by onset - TEAEs that are possibly related to the investigational product - TEAEs that are possibly related to the investigational product by severity - TEAEs that led to the discontinuation of study vaccination - Serious TEAEs For body temperature, summary statistics of baseline values and observed values at each time point of evaluation will be calculated. On the basis of health diary entries, local and systemic reactions will be summarized using frequency distributions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: Proportion of subjects with anti-polyribosylribitol phosphate (PRP) antibody response and geometric mean antibody titer (GMT) Secondary timeframeFor 64 weeks At each time point of evaluation, the proportion of subjects with an anti-PRP antibody titer >=1.0 microg/mL (i.e., antibody response rate with a threshold of 1.0 microg/mL) and the proportion of subjects with an anti-PRP antibody titer >=0.15 microg/mL (i.e., antibody response rate with a threshold of 0.15 microg/mL) will be summarized using frequency distributions, and a calculation of point estimates and two-sided 95% confidence intervals will be performed. For anti-PRP antibody titers, summary statistics, GMT, and two-sided 95% confidence intervals for the GMT will be calculated. To calculate the two-sided 95% confidence interval for the GMT at each time point of evaluation, the mean of log-transformed antibody titer values will be calculated first, and then the upper and lower limits of the two-sided 95% confidence interval for the mean will be inverse log-transformed. | — |
Outcome results
None listed