Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
416 participants
INTERVENTIONAL
2011-06-30
2013-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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TAK-816
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.
ActHIB
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
3 Months
6 Months
ALL
Yes
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Senior Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Isumi, Chiba, Japan
Urayasu-shi, Chiba, Japan
Fukuoka, Fukuoka, Japan
Itoshima-shi, Fukuoka, Japan
Kasuga-shi, Fukuoka, Japan
Hiroshima, Hiroshima, Japan
Yokohama, Kanagawa, Japan
Kumamoto, Kumamoto, Japan
Tsu, Mie-ken, Japan
Okayama, Okayama-ken, Japan
Kumagaya-shi, Saitama, Japan
Shizuoka, Shizuoka, Japan
Fuchu-shi, Tokyo, Japan
Koto-ku, Tokyo, Japan
Nishi-Tokyo-shi, Tokyo, Japan
Oota-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Suginami-ku, Tokyo, Japan
Tachikawa-shi, Tokyo, Japan
Tama-shi, Tokyo, Japan
Kofu, Yamanashi, Japan
Tsuru-shi, Yamanashi, Japan
Countries
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References
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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.
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.
Other Identifiers
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JapicCTI-111516
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1122-0130
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-816/CCT-001
Identifier Type: -
Identifier Source: org_study_id
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