Clinical trial NCT01379846: Study of TAK-816 in Healthy Infants
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Immunization
Keywords: Immunostimulation
Haemophilus b conjugate vaccine
HIB
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-06-23
Enrollment: 416
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility 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.

Primary outcomes:
measure: Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥1 ϻg/mL
timeFrame: 4 weeks after the third dose (Visit 4)
Secondary outcomes:
measure: Proportion of participants with an anti-polyribosylribitol phosphate (PRP) titer ≥0.15 ϻg/mL
timeFrame: 4 weeks after the third dose (Visit 4)
measure: Proportion of participants with an anti-PRP geometric mean titers (GMT)
timeFrame: 4 weeks after the third dose (Visit 4)
measure: Proportion of participants with an anti-PRP titer ≥1 ϻg/mL
timeFrame: 4 weeks after the single booster dose. (Visit 6)
measure: Proportion of participants with an anti-PRP titer ≥0.15 ϻg/mL
timeFrame: 4 weeks after the single booster dose. (Visit 6)
measure: Proportion of participants with an anti-PRP GMT
timeFrame: 4 weeks after the single booster dose. (Visit 6)
measure: Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL
timeFrame: 4 weeks after the third dose (Visit 4)
measure: Proportion of participants with an anti-diphtheria toxoid GMT
timeFrame: 4 weeks after the third dose (Visit 4)
measure: Proportion of participants with an anti-diphtheria toxoid titer ≥0.1 IU/mL
timeFrame: 4 weeks after the single booster dose (Visit 6)
measure: Proportion of participants with an anti-diphtheria toxoid GMT
timeFrame: 4 weeks after the single booster dose (Visit 6)
measure: Proportion of participants with an anti-pertussis toxin (PT) titer ≥10 EU/mL
timeFrame: 4 weeks after the third dose (Visit 4)
measure: Proportion of participants with an anti-PT GMT
timeFrame: 4 weeks after the third dose (Visit 4)
measure: Proportion of participants with an anti-PT titer ≥10 EU/mL
timeFrame: 4 weeks after the single booster dose (Visit 6)
measure: Proportion of participants with an anti-PT GMT
timeFrame: 4 weeks after the single booster dose (Visit 6)
measure: Proportion of participants with an anti-filamentous hemagglutinin (FHA) titer ≥10 EU/mL
timeFrame: 4 weeks after the third dose (Visit 4)
measure: Proportion of participants with an anti-FHA GMT
timeFrame: 4 weeks after the third dose (Visit 4)
measure: Proportion of participants with an anti-FHA titer ≥10 EU/mL
timeFrame: 4 weeks after the single booster dose (Visit 6)
measure: Proportion of participants with an anti-FHA GMT
timeFrame: 4 weeks after the single booster dose (Visit 6)
measure: Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL
timeFrame: 4 weeks after the third dose (Visit 4)
measure: Proportion of participants with an anti-tetanus toxoid GMT
timeFrame: 4 weeks after the third dose (Visit 4)
measure: Proportion of participants with an anti-tetanus toxoid titer ≥0.01 IU/mL
timeFrame: 4 weeks after the single booster dose (Visit 6)
measure: Proportion of participants with an anti-tetanus toxoid GMT
timeFrame: 4 weeks after the single booster dose (Visit 6)
Other outcomes:
Locations:
city: Isumi-shi
country: Japan
state: Chiba
city: Urayasu-shi
country: Japan
state: Chiba
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Itoshima-shi
country: Japan
state: Fukuoka
city: Kasuga-shi
country: Japan
state: Fukuoka
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Yokohama-shi
country: Japan
state: Kanagawa
city: Kumamoto-shi
country: Japan
state: Kumamoto
city: Tsu-shi
country: Japan
state: Mie
city: Okayama-shi
country: Japan
state: Okayama
city: Kumagaya-shi
country: Japan
state: Saitama
city: Shizuoka-shi
country: Japan
state: Shizuoka
city: Fuchu-shi
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
city: Nishitokyo-shi
country: Japan
state: Tokyo
city: Oota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Suginami-ku
country: Japan
state: Tokyo
city: Tachikawa-shi
country: Japan
state: Tokyo
city: Tama-shi
country: Japan
state: Tokyo
city: Koufu-shi
country: Japan
state: Yamanashi
city: Tsuru-shi
country: Japan
state: Yamanashi
Study officials:
affiliation: Takeda
name: Senior Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.