Trials Sponsors Conditions Drugs Pricing

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.

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.

Interventions

TAK-850 0.5 mL injectionDrug

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 injectionDrug

TAK-850 intramuscular injection

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

Eligibility Criteria

Age6 Months - 19 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (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.

Sponsors & Collaborators

Takeda
Industrylead

Study Sites (2)

Chuou-ku, Tokyo, Japan

Setagaya-ku, Tokyo, Japan

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Results Point of Contact

Title: Medical Director
Organization: Takeda

Study Officials

General Manager
Takeda
STUDY DIRECTOR

Publication Agreements

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

Enrollment

99 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
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 2015

Date type not reported

This date has not been verified as actual or estimated.

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).
+8 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (9)

Secondary Outcomes (16)

Study Arms (3)

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 (6-35 months of age)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (9)

Secondary Outcomes (16)

Study Arms (3)

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 (6-35 months of age)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations