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

NCT02367885 | Completed Phase 1 Results

• 3 other identifiers: TAK-850/CCT-101U1111-1166-6015JapicCTI-152807
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza Infection

Keywords

Prevention

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 6-35 Months Old Group

  Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site tenderness, Injection site ecchymosis, Irritability postvaccinal) and systemic events (Pyrexia, sweaty, vomiting, crying abnormal, inappetence, somnolence, sleeplessness) were reported. Participants may be represented in more than 1 category.

  Up to 21 days after any vaccination

• Number of Participants With Solicited Local and Systemic Adverse Events (AEs) for 3-12 Years Old Group and 13-19 Years Old Group

  Local reactions and systemic events were recorded using a diary. Number of participants with local reactions (Injection site pain, Injection site redness, Injection site swelling, Injection site induration, Injection site tenderness, Injection site ecchymosis) and systemic events (Pyrexia, malaise, chills, fatigue, headache, sweaty, myalgia, nausea, vomiting) were reported. Participants may be represented in more than 1 category.

  Up to 21 days after any vaccination

• Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  An 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 (example, 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 TEAE is defined as an adverse event with an onset that occurs after receiving study drug. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.

  Up to 21 days after any vaccination

• 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

  Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40.

  Day 22 (21 days after Vaccination)

• 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

  Seroprotection rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroprotection rate was defined as the percentage of participants with HI antibody titer of \>=40.

  Day 43 (21 days after Vaccination 2)

• 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

  Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with a baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).

  Day 22 (21 days after Vaccination)

• 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

  Seroconversion rate was measured by HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from baseline (with a baseline HI antibody titer of \>=10), or achieving a HI antibody titer of \>=40 (with a baseline HI antibody titer of \<10) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain).

  Day 43 (21 days after Vaccination 2)

• 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

  GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination for the age group of 13-19 years.

  Day 22 (21 days after Vaccination)

• 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

  GMFI from baseline in HI antibody titer (egg-derived antigen) for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after second vaccination for two age groups: 6-35 months and 3-12 years.

  Day 43 (21 days after Vaccination 2)

Secondary Outcomes (16)

• 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

  Day 22 (21 days after Vaccination 1)

• 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

  Day 22 (21 days after Vaccination 1)

• 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

  Day 22 (21 days after Vaccination 1)

• Geometric Mean Titer (GMT) of HI Antibody Titer (Egg-Derived Antigen)

  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)

• Percentage of Participants With Seroprotection in Single Radial Hemolysis (SRH) Antibody Titer (Egg- Derived Antigen) of >=25 Square Millimeter (mm^2)

  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)

Study Arms (3)

TAK-850 0.5 mL injection (13-19 years of age)

EXPERIMENTAL

Single intramuscular injection of TAK-850 0.5 mL in participants aged 13-19 years

Drug: TAK-850 0.5 mL injection

TAK-850 0.5 mL injection (3-12 years of age)

EXPERIMENTAL

Two intramuscular injections of TAK-850 0.5 mL in participants aged 3-12 years old.

Drug: TAK-850 0.5 mL injection

TAK-850 0.25 mL injection (6-35 months of age)

EXPERIMENTAL

Two intramuscular injections of TAK-850 0.25 mL in participants aged 6-35 months old.

Drug: TAK-850 0.25 mL injection

Interventions

TAK-850 0.5 mL injection DRUG

TAK-850 injection

TAK-850 0.5 mL injection (13-19 years of age); TAK-850 0.5 mL injection (3-12 years of age)

TAK-850 0.25 mL injection DRUG

TAK-850 intramuscular injection

TAK-850 0.25 mL injection (6-35 months of age)

Eligibility Criteria

• Age: 6 Months - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• The participant's representative can sign and date a written, informed consent form prior to the initiation of any study procedures.
• The participant is a healthy Japanese child.
• The participant is aged 6 months to 19 years, inclusive, at the time of starting to receive the study vaccine.
• 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.

You may not qualify if:

• \[Only for participants at the age of 6-35 months old\]
• 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).
• The participant has received any investigational compound within 4 months prior to the initial injection of study vaccine.
• The participant has been vaccinated with seasonal influenza vaccine within 6 months prior to the initial injection of study vaccine.
• The participant has a history of influenza infection within 6 months prior to the initial injection of study vaccine.
• 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.
• 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.
• The participant has an armpit temperature ≥ 37.5°C prior to the initial injection of study vaccine on Day 1.
• The participant has any medically diagnosed or suspected immune deficient condition.
• 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.
• The participant has received antipyretics within 4 hours prior to the initial injection of study vaccine.
• The participant has a history of Guillain-Barré Syndrome, demyelinating disorders (including acute disseminated encephalomyelitis \[ADEM\] and multiple sclerosis) or convulsions.
• The participant has a functional or surgical asplenia.
• 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.
• The participant has a history of, or is infected with the Hepatitis B Virus (HBsAgs), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

Unknown Facility

Chuou-ku, Tokyo, Japan

Location

Unknown Facility

Setagaya-ku, Tokyo, Japan

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

clinicaltrialregistry@tpna.com

+1-877-825-3327

Study Officials

• General Manager

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 20, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: April 7, 2016
• Results First Posted: April 7, 2016

Record last verified: 2016-03

Locations

JP (2)