Prevention of Infections Caused by Haemophilus Influenzae Type b Clinical Trial
Official title:
A Phase III, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of Intramuscular TAK-816 in Healthy Infants
| Verified date | June 2015 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
The purpose of this study is to evaluate the safety of intramuscular TAK-816 in healthy Japanese infants.
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 2 Months to 6 Months |
| Eligibility |
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: 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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency of Adverse events | The frequencies of all adverse reactions observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. Among these, events which are considered possibly associated with a medicinal product are defined as adverse reactions. | For 64 weeks | Yes |
| Primary | Body temperature | For body temperature, summary statistics of baseline values and observed values at each time point of evaluation will be calculated. | For 64 weeks | Yes |
| Primary | Health diaries | On the basis of health diary entries which subject's caregiver records, local and systemic reactions will be summarized using frequency distributions. | For 64 weeks | Yes |
| Secondary | Proportion of subjects with anti-polyribosylribitol phosphate (PRP) antibody response | At each time point of evaluation, the proportion of subjects with an anti-PRP antibody titer = 1.0 µg/mL (i.e., antibody response rate with a threshold of 1.0 µg/mL) and the proportion of subjects with an anti-PRP antibody titer = 0.15 µg/mL (i.e., antibody response rate with a threshold of 0.15 µg/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, geometric mean titer (GMT), and two-sided 95% confidence intervals for the GMT will be calculated. | For 64 weeks | No |
| Secondary | Geometric mean titer (GMT) of anti-PRP antibody | 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. | For 64 weeks | No |