Phase III Study of Intramuscular TAK-816 in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT02074345
First received: February 26, 2014
Last updated: March 24, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.

Condition Intervention Phase
Healthy Volunteers
Haemophilus Influenzae Type b, Prevention
Biological: TAK-816
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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:
  • Number of Participants With Adverse Events [ Time Frame: For 64 Weeks ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia) [ Time Frame: For 64 Weeks ] [ Designated as safety issue: Yes ]
    Body temperature was assessed for 14 days after each vaccination and was recorded by the caregiver in a diary. Adverse reactions related body temperature was reported as pyrexia.

  • Number of Participants With Adverse Reactions Related to Local Reactions [ Time Frame: For 64 Weeks ] [ Designated as safety issue: Yes ]
    Local Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Local reactions (injection site) were erythema, swelling, induration and pain (tenderness).

  • Number of Participants With Adverse Reactions Related to Systemic Reactions [ Time Frame: For 64 Weeks ] [ Designated as safety issue: Yes ]
    Systemic Reactions were assessed 14 days after each vaccination and were recorded by the caregiver in a diary. Systemic reactions were rash, irritability, crying, decreased appetite, vomiting, diarrhoea, somnolence (sleepiness) and insomnia (sleeplessness).


Secondary Outcome Measures:
  • Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL [ Time Frame: For 64 weeks ] [ Designated as safety issue: No ]
    Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Haemophilus influenzae type b (Hib) as an assessment of immunogenicity.

  • Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL [ Time Frame: For 64 weeks ] [ Designated as safety issue: No ]
    Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.

  • Geometric Mean Titer (GMT) of Anti-PRP Antibody [ Time Frame: For 64 weeks ] [ Designated as safety issue: No ]
    Blood was collected and was sent to a central laboratory for the evaluation of anti-PRP antibody titer against Hib as an assessment of immunogenicity.


Enrollment: 31
Study Start Date: March 2014
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-816 0.5 mL
Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
Biological: TAK-816
TAK-816 intramuscular injection

Detailed Description:

The vaccine being tested in this study is called TAK-816. TAK-816 was being tested to evaluate its safety and immune response after intramuscular (IM) injection with TAK-816. This study evaluated adverse events and the seroprotection rate and geometric mean titer (GMT) of anti-polyribosylribitol phosphate (PRP)-antibodies in participants who were administered TAK-816 IM.

The study enrolled 31 participants. All participants received 3 doses of TAK-816 IM at 4-week intervals as part of the primary vaccination and 1 booster vaccination 52 weeks after the third dose of the primary vaccination.

This multi-center trial was conducted in Japan. The overall time to participate in this study was 64 weeks. Participants made multiple visits to the clinic including a final visit 4 weeks after last dose of study drug for a follow-up assessment.

  Eligibility

Ages Eligible for Study:   2 Months to 6 Months   (Child)
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.
  4. The legal guardian signed and dated a written, informed consent form prior to the initiation of any study procedures.

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 antibody products not containing any components of Hib 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.
  12. Children considered ineligible for the study for other reasons by the investigator or subinvestigator.
  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

Locations
Japan
Kumagaya-shi, Saitama, Japan
Fuchu-shi, Tokyo, Japan
Suginami-ku, Tokyo, Japan
Koufu-shi, Yamanashi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02074345     History of Changes
Other Study ID Numbers: TAK-816/OCT-002  U1111-1153-4027  JapicCTI-142454 
Study First Received: February 26, 2014
Results First Received: March 24, 2016
Last Updated: March 24, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Drug therapy
Safety and immunogenicity of Hib vaccine

ClinicalTrials.gov processed this record on August 25, 2016