Active immunisation against invasive disease caused by Haemophilus influenzae type b
Conditions
Interventions
investigational material(s)
Generic name etc : TAK-816, DPT-TAKEDA
INN of investigational material :
Therapeutic category code : 631 Vaccines
Dosage and Administration for Investigational material :
Sponsors
Takeda Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female infants aged =>3 and <7 months (excluding hospitalized infants). 2. Infants whose legal acceptable representatives have given informed consent to the study prior to enrollment. 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. History of possible pertussis, diphtheria or tetanus infection. 5. Previously diagnosed immunodeficiency. 6. A documented history of anaphylaxis to any ingredient of the investigational products (TAK-816, ActHIB or DPT-TAKEDA). 7. A history of convulsions. 8. Previous administration of another Hib vaccine. 9. Previous administration of any other vaccine containing any of the components of polio, diphtheria, pertussis, or tetanus. 10. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer =>1 mcg/mL at 4 weeks after the third dose. For each treatment group in the full analysis set (FAS), the proportion of subjects with an anti-PRP titer =>1 mcg/mL at 4 weeks after the last of the three priming doses (primary endpoint) will be determined and the point estimate and its two-sided 95% confidence interval will be calculated. To compare the two groups, the point estimate and its two-sided 95% confidence interval will be calculated for the treatment difference with regard to this endpoint (TAK-816 group [PV] - ActHIB group [PA]). The noninferiority of TAK-816 against ActHIB will be tested by the Chi-square test with a noninferiority margin of 10%. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Proportion of participants with an anti-PRP titer =>0.15 mcg/mL and anti-PRP geometric mean titer (GMT) at 4 weeks after third dose. Proportions of participants with an anti-PRP titer =>1 and =>0.15 mcg/mL and anti-PRP GMT at 4 weeks after the single booster dose. Proportions of participants with a protective level of anti-DPT (antibodies against diphtheria toxin, Bordetella pertussis [PH and FHA] and tetanus toxin) titer as well as anti-DPT GMTs at 4 weeks after the third dose and at 4 weeks after the single booster dose. Seroprotection will be summarized for each treatment group, and point estimates and 95% confidence intervals (two-sided) will be calculated. In addition, point estimates and 95% confidence intervals (two-sided) for intergroup differences (TAK-816 group vs. ActHIB group) will be calculated. Furthermore, summary statistics of GMT antibody titers GMT and 95% confidence intervals (two-sided) for each treatment group will be calculated. Finally, point estimates and 95% confidence intervals (two-sided) for intergroup difference (TAK-816 group vs. ActHIB group) will be calculated. Anti-diphtheria toxoid antibody titer: 0.1 IU / mL Anti-PT and anti-FHA antibody titer: 10 EU / mL Anti-tetanus toxoid antibody titer: 0.01 IU / mL | — |
Outcome results
None listed