NCT01379846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
416

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 5, 2013

Status Verified

March 1, 2013

Enrollment Period

1.7 years

First QC Date

June 21, 2011

Last Update Submit

March 4, 2013

Conditions

Immunization

Keywords

ImmunostimulationHaemophilus b conjugate vaccineHIB

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥1 Ï»g/mL

    4 weeks after the third dose (Visit 4)

Secondary Outcomes (21)

  • Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥0.15 Ï»g/mL

    4 weeks after the third dose (Visit 4)

  • Proportion of participants with an anti-PRP geometric mean titers (GMT)

    4 weeks after the third dose (Visit 4)

  • Proportion of participants with an anti-PRP titer ≥1 Ï»g/mL

    4 weeks after the single booster dose. (Visit 6)

  • Proportion of participants with an anti-PRP titer ≥0.15 Ï»g/mL

    4 weeks after the single booster dose. (Visit 6)

  • Proportion of participants with an anti-PRP GMT

    4 weeks after the single booster dose. (Visit 6)

  • +16 more secondary outcomes

Study Arms (2)

TAK-816

EXPERIMENTAL
Biological: TAK-816+ DPT-TAKEDA

ActHIB

ACTIVE COMPARATOR
Biological: ActHIB+ DPT-TAKEDA

Interventions

TAK-816+ DPT-TAKEDABIOLOGICAL

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.

Also known as: Vaxem Hib
TAK-816
ActHIB+ DPT-TAKEDABIOLOGICAL

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.

Also known as: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
ActHIB

Eligibility Criteria

Age3 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male or female infants aged ≥3 and \<7 months (excluding hospitalized infants).
  • Infants whose legal acceptable representatives have given informed consent to the study prior to enrollment.
  • Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.

You may not qualify if:

  • Any serious acute illness.
  • Any underlying cardiovascular, renal, hepatic, or hematologic disease, and/or developmental disorder.
  • History of possible Haemophilus influenzae type b (Hib) infection.
  • History of possible pertussis, diphtheria or tetanus infection.
  • Previously diagnosed immunodeficiency.
  • A documented history of anaphylaxis to any ingredient of the investigational products (TAK-816, ActHIB or DPT-TAKEDA).
  • A history of convulsions.
  • Previous administration of another Hib vaccine.
  • Previous administration of any other vaccine containing any of the components of polio, diphtheria, pertussis, or tetanus.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Unknown Facility

Isumi, Chiba, Japan

Location

Unknown Facility

Urayasu-shi, Chiba, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Itoshima-shi, Fukuoka, Japan

Location

Unknown Facility

Kasuga-shi, Fukuoka, Japan

Location

Unknown Facility

Hiroshima, Hiroshima, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Tsu, Mie-ken, Japan

Location

Unknown Facility

Okayama, Okayama-ken, Japan

Location

Unknown Facility

Kumagaya-shi, Saitama, Japan

Location

Unknown Facility

Shizuoka, Shizuoka, Japan

Location

Unknown Facility

Fuchu-shi, Tokyo, Japan

Location

Unknown Facility

Koto-ku, Tokyo, Japan

Location

Unknown Facility

Nishi-Tokyo-shi, Tokyo, Japan

Location

Unknown Facility

Oota-ku, Tokyo, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, Japan

Location

Unknown Facility

Suginami-ku, Tokyo, Japan

Location

Unknown Facility

Tachikawa-shi, Tokyo, Japan

Location

Unknown Facility

Tama-shi, Tokyo, Japan

Location

Unknown Facility

Kofu, Yamanashi, Japan

Location

Unknown Facility

Tsuru-shi, Yamanashi, Japan

Location

Related Publications (2)

  • Akeda Y, Koizumi Y, Takanami Y, Sumino S, Hattori Y, Sugizaki K, Mitsuya N, Oishi K. Comparison of serum bactericidal and antibody titers induced by two Haemophilus influenzae type b conjugate vaccines: A phase III randomized double-blind study. Vaccine. 2018 Mar 14;36(12):1528-1532. doi: 10.1016/j.vaccine.2018.02.011. Epub 2018 Feb 17.

    PMID: 29459064DERIVED

  • Togashi T, Mitsuya N, Kogawara O, Sumino S, Takanami Y, Sugizaki K. Immunogenicity and safety of a fully liquid aluminum phosphate adjuvanted Haemophilus influenzae type b PRP-CRM197-conjugate vaccine in healthy Japanese children: A phase III, randomized, observer-blind, multicenter, parallel-group study. Vaccine. 2016 Aug 31;34(38):4635-4641. doi: 10.1016/j.vaccine.2016.05.050. Epub 2016 Jul 26.

    PMID: 27265451DERIVED

MeSH Terms

Interventions

HibTITER protein, Haemophilus influenzae

Study Officials

  • Senior Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 23, 2011

Study Start

June 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 5, 2013

Record last verified: 2013-03

Locations

JP(22)