Study of TAK-816 in Healthy Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01379846
First received: June 21, 2011
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to evaluate the efficacy (immunogenicity) of TAK-816 when administered to healthy Japanese infants as multiple subcutaneous doses.


Condition Intervention Phase
Immunization
Biological: TAK-816+ DPT-TAKEDA
Biological: ActHIB+ DPT-TAKEDA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Multicenter, Parallel-Group Comparative Phase III Study Evaluating the Efficacy and Safety of TAK-816 Compared With ActHIB in Healthy Infants

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥1 ϻg/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥0.15 ϻg/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-PRP geometric mean titers (GMT) [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-PRP titer ≥1 ϻg/mL [ Time Frame: 4 weeks after the single booster dose. (Visit 6) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-PRP titer ≥0.15 ϻg/mL [ Time Frame: 4 weeks after the single booster dose. (Visit 6) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-PRP GMT [ Time Frame: 4 weeks after the single booster dose. (Visit 6) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-diphtheria toxoid GMT [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL [ Time Frame: 4 weeks after the single booster dose (Visit 6) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-diphtheria toxoid GMT [ Time Frame: 4 weeks after the single booster dose (Visit 6) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-pertussis toxin (PT) titer ≥10 EU/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-PT GMT [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-PT titer ≥10 EU/mL [ Time Frame: 4 weeks after the single booster dose (Visit 6) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-PT GMT [ Time Frame: 4 weeks after the single booster dose (Visit 6) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-filamentous hemagglutinin (FHA) titer ≥10 EU/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-FHA GMT [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-FHA titer ≥10 EU/mL [ Time Frame: 4 weeks after the single booster dose (Visit 6) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-FHA GMT [ Time Frame: 4 weeks after the single booster dose (Visit 6) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-tetanus toxoid GMT [ Time Frame: 4 weeks after the third dose (Visit 4) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL [ Time Frame: 4 weeks after the single booster dose (Visit 6) ] [ Designated as safety issue: No ]
  • Proportion of participants with an anti-tetanus toxoid GMT [ Time Frame: 4 weeks after the single booster dose (Visit 6) ] [ Designated as safety issue: No ]

Enrollment: 416
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-816 Biological: TAK-816+ DPT-TAKEDA
TAK-816 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose.
Other Name: Vaxem Hib
Active Comparator: ActHIB Biological: ActHIB+ DPT-TAKEDA
ActHIB 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose.
Other Name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

Detailed Description:

Haemophilus Influenzae type b (Hib) is one of the major causes of infectious meningitis in children, and can also cause sepsis, cellulitis, arthritis, epiglottitis, pneumonia and myelitis.

TAK-816 is a conjugated Hib vaccine being tested in healthy infants aged 3-6 months at the time of the first dose.

The objective of this study is to evaluate the efficacy (immunogenicity) and safety of TAK-816 (10 ϻg/0.5 mL) in comparison with ActHIB (Haemophilus b Conjugate Vaccine) as a control.

In addition, the efficacy (immunogenicity) and safety of Absorbed Diphtheria-Purified Pertussis-Tetanus Combined (DPT-TAKEDA) vaccine when TAK-816 and DPT vaccine are administered concomitantly will also be investigated.

For the Primary Immunization Phase of this study: three doses of TAK-816 or ActHIB 10 µg/0.5 mL and DPT-TAKEDA 0.5 mL will be administered at 4-week intervals over 8 weeks (Visit 1, 2, 3). At4 weeks after the third dose, a follow-up observation and evaluation will be made (Visit 4).

For the Booster Vaccination Phase of this study: a single dose of TAK-816 or ActHIB 10 µg/0.5 mL and DPT-TAKEDA 0.5 mL will be given at 52 weeks after the third dose (Visit 5). At 4 weeks after the fourth dose, a follow-up observation and evaluation will be made (Visit 6).

  Eligibility

Ages Eligible for Study:   3 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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.
  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: NCT01379846

Locations
Japan
Isumi-shi, Chiba, Japan
Urayasu-shi, Chiba, Japan
Fukuoka-shi, Fukuoka, Japan
Itoshima-shi, Fukuoka, Japan
Kasuga-shi, Fukuoka, Japan
Hiroshima-shi, Hiroshima, Japan
Yokohama-shi, Kanagawa, Japan
Kumamoto-shi, Kumamoto, Japan
Tsu-shi, Mie, Japan
Okayama-shi, Okayama, Japan
Kumagaya-shi, Saitama, Japan
Shizuoka-shi, Shizuoka, Japan
Fuchu-shi, Tokyo, Japan
Koto-ku, Tokyo, Japan
Nishitokyo-shi, Tokyo, Japan
Oota-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Suginami-ku, Tokyo, Japan
Tachikawa-shi, Tokyo, Japan
Tama-shi, Tokyo, Japan
Koufu-shi, Yamanashi, Japan
Tsuru-shi, Yamanashi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: Senior Director Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01379846     History of Changes
Other Study ID Numbers: TAK-816/CCT-001, JapicCTI-111516, U1111-1122-0130
Study First Received: June 21, 2011
Last Updated: March 4, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Takeda:
Immunostimulation
Haemophilus b conjugate vaccine
HIB

ClinicalTrials.gov processed this record on July 22, 2014