Phase 1/2 Study of TAK-850 Intramuscular Injection in Healthy Pediatric Participants

Influenza Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367885
• Other study ID #: TAK-850/CCT-101
• Secondary ID: U1111-1166-6015J
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 13, 2015
• Last updated: June 15, 2015
• Start date: February 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

The drug being tested in this study is called TAK-850, that is being developed as a pediatric vaccine for influenza infection. This study will evaluate the safty and immunogenicity of TAK-850 in healthy Japanese children when given as a intramuscular injection

The study will enroll approximately 99 participants (33 per treatment group) to receive TAK-850 in open label fashon, 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, and

• Two injections of TAK-850/0.25 mL in 6 to 35 months old healthy Japanese children..

Participants will be asked to take body temperature in the evening for seven days post vaccination and record in the diary provided.

This trial will be conducted at 2 sites in Japan. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 19 Years

Eligibility

Inclusion Criteria:

• 1. In the opinion of the investigator or the subinvestigator, the participant 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 1 month after the completion of the study.

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza Infection

Intervention

Drug:
• TAK-850 0.5 mL injection
TAK-850 intramuscular injection for 13-19 year olds
• TAK-850 0.5 mL injection (3-12 year olds)
Two intramuscular injections of TAK-850 0.5 mL in 3-12 year old participants
• TAK-850 0.25 mL injection (age 6-35 months)
Two intramuscular injections of TAK-850 0.25 mL in 6-35 month old participants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequencies of solicited local and systemic adverse events (AEs)	The frequencies of solicited local and systemic adverse events (AEs) will be tabulated by age group, severity and day of onset. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event which occurs after the initial injection of study vaccine.	Up to 22 days (13-19 year olds) or 43 days (6 months to 12 year olds)	Yes
Primary	Frequencies of all AEs	The frequencies of all adverse reactions observed during the observation period will be tabulated by age group, severity and day of onset. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event which occurs after the initial injection of study vaccine.	Up to 22 days (13-19 year olds) or 43 days (6 months to 12 year olds)	Yes
Primary	Seroprotection rate as measured by hemagglutination inhibition [HI] antibody titer (egg-derived viral antigen (hereinafter, egg-derived antigen) for each of the three strains	Seroprotection rate as measured by HI antibody titer (egg-derived antigen) (determined as the percentage of participants with HI antibody titer of = 40) for each of the three strains, 21 days after the initial vaccination (13-19 years old) or 21 days after the second vaccination (6 months to 12 years old). Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or Day 43 (6 months to 12 year olds)	No
Primary	Seroconversion rate as measured by HI antibody titer (egg-derived antigen) for each of the three strains	Seroconversion rate as measured by HI antibody titer (egg-derived antigen) (defined as the percentage of participants achieving a minimal 4-fold increase with a baseline HI antibody titer [baseline =10], or achieving a HI antibody titer of = 40 with a baseline HI antibody titer [baseline < 10]) for each of the three strains, 21 days after the initial vaccination (13-19 years old) or 21 days after the second vaccination (6 months to 12 years old). Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 years old)	No
Primary	Geometric mean fold increase from baseline in HI antibody titer (egg-derived antigen) for each of the three strains	Geometric mean fold increase from baseline in HI antibody titer (egg-derived antigen) for each of the three strains, 21 days after the initial vaccination (13-19 years old) or 21 days after the second vaccination (6 months to 12 years old). Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 years old) or 43 Days (6 months to 12 years old)	No
Secondary	Seroprotection rate as measured by hemagglutination inhibition [HI] antibody titer (egg-derived antigen) for each of the three strains	Seroprotection rate as measured by HI antibody titer (egg-derived antigen) (determined as the percentage of participants with HI antibody titer of = 40) for each of the three strains, 21 days after the initial vaccination (6 months to 12 years old). Blood samples will be taken at predose on Day-1 and 21 days after vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 years old)	No
Secondary	Seroconversion rate as measured by HI antibody titer (egg-derived antigen) for each of the three strains	Seroconversion rate as measured by HI antibody titer (egg-derived antigen) (defined as the percentage of participants achieving a minimal 4-fold increase with a baseline HI antibody titer [baseline = 10], or achieving a HI antibody titer of = 40 with a baseline HI antibody titer [baseline < 10]) for each of the three strains, 21 days after the initial vaccination (6 months to 12 years old). Blood samples will be taken at predose on Day-1 and 21 days after vaccination.	Up to 22 days (13-19 year old) or 43 Days (6 months to 12 year olds)	No
Secondary	Geometric mean fold increase from baseline in HI antibody titer (egg-derived antigen) for each of the three strains	Geometric mean fold increase from baseline in HI antibody titer (egg-derived antigen) for each of the three strains, 21 days after the initial vaccination (6 months to 12 years old).	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 year old)	No
Secondary	Geometric mean (GMT) in HI antibody titer (egg-derived antigen) for each of the three strains	Geometric mean (GMT) in HI antibody titer (egg-derived antigen) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 year olds)	No
Secondary	Seroprotection rate as measured by SRH antibody titer (egg-derived antigen) for each of the three strains	Seroprotection rate as measured by SRH antibody titer (egg-derived antigen) (determined as the percentage of participants with SRH antibody titer of = 25 mm2) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 years old)	No
Secondary	Seroconversion rate as measured by SRH antibody titer (egg-derived antigen) for each of the three strains	Seroconversion rate as measured by SRH antibody titer (egg-derived antigen) (defined as the percentage of participants achieving a minimal 50% increase with a baseline SRH antibody titer [baseline > 4 mm2], or achieving a SRH antibody titer of = 25 mm2 with a baseline SRH antibody titer [baseline = 4 mm2]) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 year olds)	No
Secondary	Geometric mean fold increase from the baseline in SRH antibody titer (egg-derived antigen) for each of the three strains	Geometric mean fold increase from the baseline in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 years old) or 43 Days (6 months to 12 years old)	No
Secondary	Geometric mean (GMT) in SRH antibody titer (egg-derived antigen) for each of the three strains	Geometric mean (GMT) in SRH antibody titer (egg-derived antigen) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 years old) or 43 Days (6 months to 12 years old)	No
Secondary	Seroprotection rate as measured by HI antibody titer (Vero-cell derived antigen (hereinafter, Vero antigen)) for each of the three strains	Seroprotection rate as measured by HI antibody titer (Vero antigen) (determined as the percentage of participants with HI antibody titer of = 40) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 year olds)	No
Secondary	Seroconversion rate as measured by HI antibody titer (Vero antigen) for each of the three strains	Seroconversion rate as measured by HI antibody titer (Vero antigen) (defined as the percentage of participants achieving a minimal 4-fold increase with a baseline HI antibody titer [baseline = 10], or achieving HI antibody titer of = 40 with a baseline HI antibody titer [baseline < 10]) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 years old) or 43 Days (6 months to 12 years old)	No
Secondary	Geometric mean fold increase from baseline in HI antibody titer (Vero antigen) for each of the three strains	Geometric mean fold increase from baseline in HI antibody titer (Vero antigen) for each of the three strains, in 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 year olds)	No
Secondary	Geometric mean (GMT) in HI antibody titer (Vero antigen) for each of the three strains	Geometric mean (GMT) in HI antibody titer (Vero antigen) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 year olds)	No
Secondary	Seroprotection rate as measured by SRH antibody titer (Vero antigen) for each of the three strains	Seroprotection rate as measured by SRH antibody titer (Vero antigen) (determined as the percentage of participants with SRH antibody titer of = 25 mm2) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 year olds)	No
Secondary	Seroconversion rate as measured by SRH antibody titer (Vero antigen) for each of the three strains	Seroconversion rate as measured by SRH antibody titer (Vero antigen) (defined as the percentage of participants achieving a minimal 50% increase with a baseline SRH antibody titer [baseline > 4 mm2], or achieving a SRH antibody titer of = 25 mm2 with a baseline SRH antibody titer [baseline = 4 mm2]) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 year olds)	No
Secondary	Geometric mean fold increase from the baseline in SRH antibody titer (Vero antigen) for each of the three strains	Geometric mean fold increase from the baseline in SRH antibody titer (Vero antigen) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 year olds)	No
Secondary	Geometric mean (GMT) in SRH antibody titer (Vero antigen) for each of the three strains	Geometric mean (GMT) in SRH antibody titer (Vero antigen) for each of the three strains, 21 days after each vaccination. Blood samples will be taken at predose on Day-1 and 21 days after each vaccination.	Up to 22 days (13-19 year olds) or 43 Days (6 months to 12 year olds)	No