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ImmunizationPhase 3NCT01379846

Study of TAK-816 in Healthy Infants

A Phase 3 study testing TAK-816+ DPT-TAKEDA and ActHIB+ DPT-TAKEDA in people with Immunization, run by Takeda at 22 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 6 monthsHealthy volunteers can take part
Conditions the study is for
Immunization
What is being tested?
TAK-816+ DPT-TAKEDA and ActHIB+ DPT-TAKEDA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
416 participants
Where
22 sitesJapan
Study dates
Jun 2011to Feb 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 6 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 10Show fewer
  • 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.

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Japan22 sites

  • Study site

    Fuchu-shi, Tokyo

  • Study site

    Fukuoka, Fukuoka

  • Study site

    Hiroshima, Hiroshima

  • Study site

    Isumi, Chiba

  • Study site

    Itoshima-shi, Fukuoka

  • Study site

    Kasuga-shi, Fukuoka

  • Study site

    Kofu, Yamanashi

  • Study site

    Koto-ku, Tokyo

  • Study site

    Kumagaya-shi, Saitama

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Nishi-Tokyo-shi, Tokyo

  • Study site

    Okayama, Okayama-ken

  • Study site

    Oota-ku, Tokyo

  • Study site

    Setagaya-ku, Tokyo

  • Study site

    Shizuoka, Shizuoka

  • Study site

    Suginami-ku, Tokyo

  • Study site

    Tachikawa-shi, Tokyo

  • Study site

    Tama-shi, Tokyo

  • Study site

    Tsu, Mie-ken

  • Study site

    Tsuru-shi, Yamanashi

  • Study site

    Urayasu-shi, Chiba

  • Study site

    Yokohama, Kanagawa

Other trials in Japan

About this study

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

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

Read the 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).

Conditions
Immunization
Being tested
TAK-816+ DPT-TAKEDA, ActHIB+ DPT-TAKEDA
Keywords
Immunostimulation, Haemophilus b conjugate vaccine, HIB

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-816+ DPT-TAKEDABiological

    Also called Vaxem Hib

    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.

  • ActHIB+ DPT-TAKEDABiological

    Also called Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)

    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.

Study groups in NCT01379846
Study groupRoleWhat they receive
TAK-816ExperimentalNot described
Receives: Biological: TAK-816+ DPT-TAKEDA
ActHIBActive comparatorNot described
Receives: Biological: ActHIB+ DPT-TAKEDA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥1 ϻg/mL

    Measured: 4 weeks after the third dose (Visit 4)

Secondary outcomes (21)

  1. Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥0.15 ϻg/mL

    Measured: 4 weeks after the third dose (Visit 4)

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

    Measured: 4 weeks after the third dose (Visit 4)

  3. Proportion of participants with an anti-PRP titer ≥1 ϻg/mL

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

  4. Proportion of participants with an anti-PRP titer ≥0.15 ϻg/mL

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

  5. Proportion of participants with an anti-PRP GMT

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

  6. Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL

    Measured: 4 weeks after the third dose (Visit 4)

  7. Proportion of participants with an anti-diphtheria toxoid GMT

    Measured: 4 weeks after the third dose (Visit 4)

  8. Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL

    Measured: 4 weeks after the single booster dose (Visit 6)

  9. Proportion of participants with an anti-diphtheria toxoid GMT

    Measured: 4 weeks after the single booster dose (Visit 6)

  10. Proportion of participants with an anti-pertussis toxin (PT) titer ≥10 EU/mL

    Measured: 4 weeks after the third dose (Visit 4)

  11. Proportion of participants with an anti-PT GMT

    Measured: 4 weeks after the third dose (Visit 4)

  12. Proportion of participants with an anti-PT titer ≥10 EU/mL

    Measured: 4 weeks after the single booster dose (Visit 6)

  13. Proportion of participants with an anti-PT GMT

    Measured: 4 weeks after the single booster dose (Visit 6)

  14. Proportion of participants with an anti-filamentous hemagglutinin (FHA) titer ≥10 EU/mL

    Measured: 4 weeks after the third dose (Visit 4)

  15. Proportion of participants with an anti-FHA GMT

    Measured: 4 weeks after the third dose (Visit 4)

  16. Proportion of participants with an anti-FHA titer ≥10 EU/mL

    Measured: 4 weeks after the single booster dose (Visit 6)

  17. Proportion of participants with an anti-FHA GMT

    Measured: 4 weeks after the single booster dose (Visit 6)

  18. Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL

    Measured: 4 weeks after the third dose (Visit 4)

  19. Proportion of participants with an anti-tetanus toxoid GMT

    Measured: 4 weeks after the third dose (Visit 4)

  20. Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL

    Measured: 4 weeks after the single booster dose (Visit 6)

  21. Proportion of participants with an anti-tetanus toxoid GMT

    Measured: 4 weeks after the single booster dose (Visit 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2011 (estimated)
  2. Study startJun 2011
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
416 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01379846
Sponsor's protocol ID
TAK-816/CCT-001
Other IDs
JapicCTI-111516, U1111-1122-0130
Status last verified
Mar 2013
First submitted
21 Jun 2011
Last updated
5 Mar 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29459064

  • 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.

    PubMed 27265451

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TAK-816+ DPT-TAKEDA and ActHIB+ DPT-TAKEDA in people with Immunization, run by Takeda at 22 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥1 ϻg/mL (time frame: 4 weeks after the third dose (Visit 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01379846, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2013.

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