We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of TAK-816 in Healthy Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01379846
Recruitment Status : Completed
First Posted : June 23, 2011
Last Update Posted : March 5, 2013
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Immunization Biological: TAK-816+ DPT-TAKEDA Biological: ActHIB+ DPT-TAKEDA Phase 3

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).

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥1 ϻg/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ]

Secondary Outcome Measures :
  1. Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥0.15 ϻg/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ]
  2. Proportion of participants with an anti-PRP geometric mean titers (GMT) [ Time Frame: 4 weeks after the third dose (Visit 4) ]
  3. Proportion of participants with an anti-PRP titer ≥1 ϻg/mL [ Time Frame: 4 weeks after the single booster dose. (Visit 6) ]
  4. Proportion of participants with an anti-PRP titer ≥0.15 ϻg/mL [ Time Frame: 4 weeks after the single booster dose. (Visit 6) ]
  5. Proportion of participants with an anti-PRP GMT [ Time Frame: 4 weeks after the single booster dose. (Visit 6) ]
  6. Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ]
  7. Proportion of participants with an anti-diphtheria toxoid GMT [ Time Frame: 4 weeks after the third dose (Visit 4) ]
  8. Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL [ Time Frame: 4 weeks after the single booster dose (Visit 6) ]
  9. Proportion of participants with an anti-diphtheria toxoid GMT [ Time Frame: 4 weeks after the single booster dose (Visit 6) ]
  10. Proportion of participants with an anti-pertussis toxin (PT) titer ≥10 EU/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ]
  11. Proportion of participants with an anti-PT GMT [ Time Frame: 4 weeks after the third dose (Visit 4) ]
  12. Proportion of participants with an anti-PT titer ≥10 EU/mL [ Time Frame: 4 weeks after the single booster dose (Visit 6) ]
  13. Proportion of participants with an anti-PT GMT [ Time Frame: 4 weeks after the single booster dose (Visit 6) ]
  14. Proportion of participants with an anti-filamentous hemagglutinin (FHA) titer ≥10 EU/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ]
  15. Proportion of participants with an anti-FHA GMT [ Time Frame: 4 weeks after the third dose (Visit 4) ]
  16. Proportion of participants with an anti-FHA titer ≥10 EU/mL [ Time Frame: 4 weeks after the single booster dose (Visit 6) ]
  17. Proportion of participants with an anti-FHA GMT [ Time Frame: 4 weeks after the single booster dose (Visit 6) ]
  18. Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL [ Time Frame: 4 weeks after the third dose (Visit 4) ]
  19. Proportion of participants with an anti-tetanus toxoid GMT [ Time Frame: 4 weeks after the third dose (Visit 4) ]
  20. Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL [ Time Frame: 4 weeks after the single booster dose (Visit 6) ]
  21. Proportion of participants with an anti-tetanus toxoid GMT [ Time Frame: 4 weeks after the single booster dose (Visit 6) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   3 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379846


Locations
Layout table for location information
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
Layout table for investigator information
Study Director: Senior Director Takeda
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01379846    
Other Study ID Numbers: TAK-816/CCT-001
JapicCTI-111516 ( Registry Identifier: JapicCTI )
U1111-1122-0130 ( Registry Identifier: WHO )
First Posted: June 23, 2011    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: March 2013
Keywords provided by Takeda:
Immunostimulation
Haemophilus b conjugate vaccine
HIB
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaccines
Immunologic Factors
Physiological Effects of Drugs