Clinical trial NCT02367885: Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric Participants
Official title: An Open-label, Multi-center, Phase 1/2 Study to Evaluate the Safety and Immunogenicity of an Intramuscular Injection of TAK-850 in Healthy Pediatric Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza Infection
Keywords: Prevention
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-02-20
Enrollment: 99
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and immunogenicity of an intramuscular injection of TAK-850 in healthy pediatric Japanese participants.

Detailed description: The drug being tested in this study is called TAK-850, that is under development as a vaccine for influenza infection. This study will evaluate the safety and immunogenicity of TAK-850 in healthy Japanese children when given as an intramuscular injection.

The study will enroll approximately 99 participants (33 per treatment group) to receive TAK-850 in open label fashion, The participants will be assigned to each treatment group as follows:

* a single intramuscular injection of TAK-850/0.5 mL in 13 to 19 years old healthy Japanese children,
* Two injections of TAK-850/0.5 mL in 3 to 12 years old healthy Japanese children,
* Two injections of TAK-850/0.25 mL in 6 to 35 months old healthy Japanese children.

The overall time to participate in this trial is 22 days (13-19 years old) or 43 days (6 months to 12 years old). Participants will make up to 2 visits (13-19 years old) or 3 visits (6 months to 12 years old) to the site.

Eligibility criteria: Inclusion Criteria:

1. In the opinion of the investigator or the subinvestigator, the participant and/or his/her representative and his/her guardian is capable of understanding and complying with protocol requirements.
2. The participant's representative can sign and date a written, informed consent form prior to the initiation of any study procedures.
3. The participant is a healthy Japanese child.
4. The participant is aged 6 months to 19 years, inclusive, at the time of starting to receive the study vaccine.
5. A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from signing of informed consent until 12 weeks after the administration.

Exclusion Criteria:

\[Only for participants at the age of 6-35 months old\]

1. The participant is a preterm newborn (gestational age was less than 37 weeks) or a low-birth-weight newborn (birth weight was less than 2500 g).
2. The participant has received any investigational compound within 4 months prior to the initial injection of study vaccine.
3. The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the initial injection of study vaccine.
4. The participant has a history of influenza infection within 6 months prior to the initial injection of study vaccine.
5. The participant is a study site employee, an immediate family member of such an employee, or in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling), or may consent under duress.
6. The participant has uncontrolled, clinically significant manifestations of neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, endocrine or other disorders, which may impact the ability of the participant to participate or potentially confound the study results.
7. The participant has an armpit temperature ≥ 37.5°C prior to the initial injection of study vaccine on Day 1.
8. The participant has any medically diagnosed or suspected immune deficient condition.
9. The participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment that can be expected to influence immune response within 30 days prior to the initial injection of study vaccine. Such treatments include, but are not limited to, systemic or high dose inhaled corticosteroids (\> 800 μg/day of beclomethasone dipropionate or equivalent; the use of inhaled and nasal steroids that do not exceed this level will be permitted), radiation treatment or other immunosuppressive or cytotoxic drugs.
10. The participant has received antipyretics within 4 hours prior to the initial injection of study vaccine.
11. The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis \[ADEM\] and multiple sclerosis) or convulsions.
12. The participant has a functional or surgical asplenia.
13. The participant has a rash, other dermatologic conditions or tattoos which may interfere with the evaluation of injection site reaction as determined by the Investigator.
14. The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
15. The participant has a known hypersensitivity to any component of TAK-850.
16. The participant has a history of severe allergic reactions or anaphylaxis.
17. The participant has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the initial injection of study vaccine or is unwilling to agree to abstain from alcohol and drugs throughout the study.
18. The participant has received any blood products (e.g. blood transfusion or immunoglobulin) within 90 days prior to the initial injection of study vaccine.
19. The participant has received a live vaccine within 4 weeks (28 days) or an inactivated vaccine within 2 weeks (14 days) prior to the initial injection of study vaccine.
20. If female, the participant is pregnant or lactating or intending to become pregnant before signing informed consent, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
21. The participant has donated whole blood ≥ 200 mL within 4 weeks (28 days), ≥ 400 mL within 12 weeks (84 days), ≥ 800 mL within 52 weeks (364 days), or blood components within 2 weeks (14 days) prior to the initial injection of study vaccine.
22. In the opinion of the investigator or subinvestigator, the participant is unlikely to comply with protocol requirements or is considered ineligible for any other reason.

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Primary outcomes:
measure: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group
timeFrame: Up to 21 days after any vaccination
measure: Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group
timeFrame: Up to 21 days after any vaccination
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 21 days after any vaccination
measure: Percentage of Participants With Seroprotection in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Vaccination for 13-19 Years Old Group
timeFrame: Day 22 (21 days after Vaccination)
measure: Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >=40: 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
timeFrame: Day 43 (21 days after Vaccination 2)
measure: Percentage of Participants With Seroconversion in Hemagglutination Inhibition (HI) Antibody Titer (Egg-Derived Antigen): 21 Days After the Vaccination for 13-19 Years Old Group
timeFrame: Day 22 (21 days after Vaccination)
measure: Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
timeFrame: Day 43 (21 days after Vaccination 2)
measure: Geometric Mean Fold Increase (GMFI) in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Vaccination for 13-19 Years Old Group
timeFrame: Day 22 (21 days after Vaccination)
measure: GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the Second Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
timeFrame: Day 43 (21 days after Vaccination 2)
Secondary outcomes:
measure: Percentage of Participants With Seroprotection in HI Antibody Titer (Egg-Derived Antigen) of >= 40: 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12- Years Old Group
timeFrame: Day 22 (21 days after Vaccination 1)
measure: Percentage of Participants With Seroconversion in HI Antibody Titer (Egg-Derived Antigen): 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
timeFrame: Day 22 (21 days after Vaccination 1)
measure: GMFI in HI Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After the First Vaccination for 6-35 Months Old Group and 3-12 Years Old Group
timeFrame: Day 22 (21 days after Vaccination 1)
measure: Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: Percentage of Participants With Seroconversion in SRH Antibody Titer (Egg-Derived Antigen)
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: GMFI in SRH Antibody Titer (Egg-Derived Antigen) From Baseline to 21 Days After Each Vaccination
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6 -35 months old group and 3-12 years old group)
measure: GMT of SRH Antibody Titer (Egg-Derived Antigen)
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: Percentage of Participants With Seroprotection in HI Antibody Titer (Vero Antigen) of >=40
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: Percentage of Participants With Seroconversion in HI Antibody Titer (Vero Antigen)
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: GMFI in HI Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: GMT of HI Antibody Titer (Vero Antigen)
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: Percentage of Participants With Seroprotection in SRH Antibody Titer (Vero Antigen) of >= 25 mm^2
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: Percentage of Participants With Seroconversion in SRH Antibody Titer (Vero Antigen)
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: GMFI in SRH Antibody Titer (Vero Antigen) From Baseline to 21 Days After Each Vaccination
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
measure: GMT of SRH Antibody Titer (Vero Antigen)
timeFrame: Day 22 (21 days after Vaccination 1 for all groups), Day 43 (21 days after Vaccination 2 for 6-35 months old group and 3-12 years old group)
Other outcomes:
Locations:
city: Chuou-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Takeda
name: General Manager
role: STUDY_DIRECTOR
References: