Clinical trial NCT02074345: Phase III Study of Intramuscular TAK-816 in Healthy Infants
Official title: A Phase III, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of Intramuscular TAK-816 in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Volunteers
Haemophilus Influenzae Type b, Prevention
Keywords: Drug therapy
Safety and immunogenicity of Hib vaccine
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-02-28
Enrollment: 31
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of intramuscular TAK-816 in healthy Japanese infants.

Detailed description: The vaccine being tested in this study is called TAK-816. TAK-816 was being tested to evaluate its safety and immune response after intramuscular (IM) injection with TAK-816. This study evaluated adverse events and the seroprotection rate and geometric mean titer (GMT) of anti-polyribosylribitol phosphate (PRP)-antibodies in participants who were administered TAK-816 IM.

The study enrolled 31 participants. All participants received 3 doses of TAK-816 IM at 4-week intervals as part of the primary vaccination and 1 booster vaccination 52 weeks after the third dose of the primary vaccination.

This multi-center trial was conducted in Japan. The overall time to participate in this study was 64 weeks. Participants made multiple visits to the clinic including a final visit 4 weeks after last dose of study drug for a follow-up assessment.

Eligibility criteria: Inclusion Criteria:

1. Healthy Japanese infants.
2. Male or female infants aged 2-6 months (≥2 and \<7 months) at the time of the first dose of investigational product (excluding hospitalized infants).
3. Infants whose parents or legal guardians have agreed to cooperate with the investigator during the study period.
4. The legal guardian signed and dated a written, informed consent form prior to the initiation of any study procedures.

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. Previously diagnosed immunodeficiency.
5. Documented history of anaphylaxis to any ingredients of the investigational product (e.g., diphtheria toxoid).
6. A history of convulsions.
7. Previous administration of another Hib vaccine.
8. 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.
9. Prior participation in any clinical study or post-marketing clinical study.
10. Previously receipt of blood transfusions, gamma globulin preparations (except monoclonal antibody products not containing any components of Hib as antigens), systemic immunosuppressive therapy, or systemic corticosteroids, or a plan to receive any of these products during the study period.
11. Presence of thrombocytopenia or coagulopathy.
12. Children considered ineligible for the study for other reasons by the investigator or subinvestigator.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: For 64 Weeks
measure: Number of Participants With Adverse Reactions Related to Body Temperature (Pyrexia)
timeFrame: For 64 Weeks
measure: Number of Participants With Adverse Reactions Related to Local Reactions
timeFrame: For 64 Weeks
measure: Number of Participants With Adverse Reactions Related to Systemic Reactions
timeFrame: For 64 Weeks
Secondary outcomes:
measure: Percentage of Participant With Anti-PRP Antibody Titer ≥ 1.0 μg/mL
timeFrame: For 64 weeks
measure: Percentage of Participant With Anti-PRP Antibody Titer ≥ 0.15 μg/mL
timeFrame: For 64 weeks
measure: Geometric Mean Titer (GMT) of Anti-PRP Antibody
timeFrame: For 64 weeks
Other outcomes:
Locations:
city: Kumagaya-shi
country: Japan
state: Saitama
city: Fuchu-shi
country: Japan
state: Tokyo
city: Suginami-ku
country: Japan
state: Tokyo
city: Koufu-shi
country: Japan
state: Yamanashi
Study officials:
affiliation: Takeda
name: Senior Manager
role: STUDY_DIRECTOR
References:
citation: Togashi T, Mitsuya N, Sumino S, Takanami Y. Safety, tolerability and immunogenicity of intramuscular administration of PRP-CRM197 Hib vaccine to healthy Japanese children: An open-label trial. Vaccine. 2018 May 17;36(21):2968-2972. doi: 10.1016/j.vaccine.2018.04.040. Epub 2018 Apr 20.