Phase III Study of Intramuscular TAK-816 in Healthy Infants
Prevention of Infections Caused by Haemophilus Influenzae Type b
Biological: TAK-816 0.5 mL
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of Intramuscular TAK-816 in Healthy Infants|
- Frequency of Adverse events [ Time Frame: For 64 weeks ] [ Designated as safety issue: Yes ]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.
- Body temperature [ Time Frame: For 64 weeks ] [ Designated as safety issue: Yes ]For body temperature, summary statistics of baseline values and observed values at each time point of evaluation will be calculated.
- Health diaries [ Time Frame: For 64 weeks ] [ Designated as safety issue: Yes ]On the basis of health diary entries which subject's caregiver records, local and systemic reactions will be summarized using frequency distributions.
- Proportion of subjects with anti-polyribosylribitol phosphate (PRP) antibody response [ Time Frame: For 64 weeks ] [ Designated as safety issue: No ]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.
- Geometric mean titer (GMT) of anti-PRP antibody [ Time Frame: For 64 weeks ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2014|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: TAK-816 0.5 mL
Three 0.5-mL doses of the vaccine will be intramuscularly injected at intervals of 28 days. In principle, the vaccine will be injected into the anterolateral aspect of the thigh, alternating between left and right.
One 0.5-mL booster dose of the vaccine will be intramuscularly injected into the anterolateral aspect of the thigh at 52 weeks after the third dose.
Biological: TAK-816 0.5 mL
Please refer to this study by its ClinicalTrials.gov identifier: NCT02074345
|Kumagaya-shi, Saitama, Japan|
|Fuchu-shi, Tokyo, Japan|
|Suginami-ku, Tokyo, Japan|
|Koufu-shi, Yamanashi, Japan|
|Study Director:||Senior Manager||Takeda|