Study of TAK-816 in Healthy Infants

March 4, 2013 updated by: Takeda

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
416

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Chiba
      • Isumi-shi, Chiba, Japan
      • Urayasu-shi, Chiba, Japan
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
      • Itoshima-shi, Fukuoka, Japan
      • Kasuga-shi, Fukuoka, Japan
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan
    • Kanagawa
      • Yokohama-shi, Kanagawa, Japan
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan
    • Mie
      • Tsu-shi, Mie, Japan
    • Okayama
      • Okayama-shi, Okayama, Japan
    • Saitama
      • Kumagaya-shi, Saitama, Japan
    • Shizuoka
      • Shizuoka-shi, Shizuoka, Japan
    • Tokyo
      • 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
    • Yamanashi
      • Koufu-shi, Yamanashi, Japan
      • Tsuru-shi, Yamanashi, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥1 ϻg/mL
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥0.15 ϻg/mL
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)
Proportion of participants with an anti-PRP geometric mean titers (GMT)
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)
Proportion of participants with an anti-PRP titer ≥1 ϻg/mL
Time Frame: 4 weeks after the single booster dose. (Visit 6)
4 weeks after the single booster dose. (Visit 6)
Proportion of participants with an anti-PRP titer ≥0.15 ϻg/mL
Time Frame: 4 weeks after the single booster dose. (Visit 6)
4 weeks after the single booster dose. (Visit 6)
Proportion of participants with an anti-PRP GMT
Time Frame: 4 weeks after the single booster dose. (Visit 6)
4 weeks after the single booster dose. (Visit 6)
Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)
Proportion of participants with an anti-diphtheria toxoid GMT
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)
Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL
Time Frame: 4 weeks after the single booster dose (Visit 6)
4 weeks after the single booster dose (Visit 6)
Proportion of participants with an anti-diphtheria toxoid GMT
Time Frame: 4 weeks after the single booster dose (Visit 6)
4 weeks after the single booster dose (Visit 6)
Proportion of participants with an anti-pertussis toxin (PT) titer ≥10 EU/mL
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)
Proportion of participants with an anti-PT GMT
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)
Proportion of participants with an anti-PT titer ≥10 EU/mL
Time Frame: 4 weeks after the single booster dose (Visit 6)
4 weeks after the single booster dose (Visit 6)
Proportion of participants with an anti-PT GMT
Time Frame: 4 weeks after the single booster dose (Visit 6)
4 weeks after the single booster dose (Visit 6)
Proportion of participants with an anti-filamentous hemagglutinin (FHA) titer ≥10 EU/mL
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)
Proportion of participants with an anti-FHA GMT
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)
Proportion of participants with an anti-FHA titer ≥10 EU/mL
Time Frame: 4 weeks after the single booster dose (Visit 6)
4 weeks after the single booster dose (Visit 6)
Proportion of participants with an anti-FHA GMT
Time Frame: 4 weeks after the single booster dose (Visit 6)
4 weeks after the single booster dose (Visit 6)
Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)
Proportion of participants with an anti-tetanus toxoid GMT
Time Frame: 4 weeks after the third dose (Visit 4)
4 weeks after the third dose (Visit 4)
Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL
Time Frame: 4 weeks after the single booster dose (Visit 6)
4 weeks after the single booster dose (Visit 6)
Proportion of participants with an anti-tetanus toxoid GMT
Time Frame: 4 weeks after the single booster dose (Visit 6)
4 weeks after the single booster dose (Visit 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-816/CCT-001
  • JapicCTI-111516 (Registry Identifier: JapicCTI)
  • U1111-1122-0130 (Registry Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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