Phase III Study of Intramuscular TAK-816 in Healthy Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02074345
First received: February 26, 2014
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the safety of intramuscular TAK-816 in healthy Japanese infants.


Condition Intervention Phase
Prevention of Infections Caused by Haemophilus Influenzae Type b
Biological: TAK-816 0.5 mL
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-816 0.5 mL

Primary immunization:

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.

Booster immunization:

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
TAK-816 injection

Detailed Description:

The purpose of this study is to evaluate the safety of intramuscular TAK-816 in healthy Japanese infants. The secondary purpose of this study is to evaluate the immunogenicity of intramuscular TAK-816 in healthy Japanese infants.

  Eligibility

Ages Eligible for Study:   2 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074345

Contacts
Contact: Takeda Study Registration Call Center +1-800-778-2860 (USA & EU) medicalinformation@tpna.com

Locations
Japan
Recruiting
Kumagaya-shi, Saitama, Japan
Recruiting
Fuchu-shi, Tokyo, Japan
Recruiting
Suginami-ku, Tokyo, Japan
Active, not recruiting
Koufu-shi, Yamanashi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02074345     History of Changes
Other Study ID Numbers: TAK-816/OCT-002, U1111-1153-4027
Study First Received: February 26, 2014
Last Updated: July 18, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014