Healthy Japanese Children Age 2 Years Through 6 YearsPhase 3NCT02269488

A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years

A Phase 3 study testing MEDI3250 in people with Healthy Japanese Children Age 2 Years Through 6 Years, run by AstraZeneca at 3 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This open-label, single arm, multicenter study will enroll approximately 100 subjects. The study is designed to gather the safety and tolerability data in Japanese children 2 to 6 years of age that would support approval of MEDI3250 in Japan. Read more about this study

Who is it for?: Ages 2 to 6 years
Conditions the study is for: Healthy Japanese Children Age 2 Years Through 6 Years
What is being tested?: MEDI3250
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 3 sitesJapan
Study dates: Nov 2014to Feb 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year.
Age 2 through 6 years of age at the time of administration.
A written informed consent should be obtained from the subject's legally acceptable representative.
Ability of the parent/guardian to understand and comply with the requirements of the protocol．
Parent/guardian available by telephone or email．

Who cannot join

Previous administration in the present study
Participation in another clinical study with an investigational product during the last 3 month
Acute illness or evidence of significant active infection at time of investigational product administration
Fever ≥99.5°F (37.5°C) at time of investigational product administration
Any drug therapy from 15 days prior to randomization or expected drug therapy through 28 days post last dose with the exception of the following classes/types of medications, which are allowed:
Topical corticosteroids, calcineurin inhibitors, or antifungals for uncomplicated dermatitis; Chronic medications (including those taken on an as-needed basis) that have been well tolerated and were not initiated and/or did not have a dosage change within 90 days prior to randomization.

Show all 17Show fewer

Current or expected receipt of immunosuppressive medications within a 28-day window around any dose, including an immunosuppressive dose of corticosteroids, which is defined as ≥20 mg/day of prednisone or its equivalent, given daily or on alternate days for ≥15 days (intranasal, intra-articular, and topical corticosteroids are permitted); Note: topical corticosteroids for uncomplicated dermatitis may be used throughout the study according to the judgment of the investigator; topical calcineurin inhibitors may be used in accordance with their package insert at entry and during study participation.
Any known immunosuppressive condition or immune deficiency disease including known or suspected infection with human immunodeficiency virus (HIV);
History of allergic disease or reactions likely to be exacerbated by any component of the investigational product including allergy to eggs, egg proteins, gentamicin, or gelatin or serious, life threatening, or severe reactions to previous influenza vaccinations;
Use of aspirin or salicylate-containing medications within 28 days prior to enrolment or expected receipt through 28 days after final vaccination;
History of Guillain-Barré syndrome;
Use of antiviral agents with activity against influenza virus (including amantadine, rimantadine, oseltamivir, and zanamivir) within 28 days prior to first dose of investigational product or anticipated use of such agents within 28 days after last scheduled vaccination;
Administration of any live virus vaccine within 30 days prior to enrolment, or if receipt of another live virus vaccine is expected within 30 days of any study vaccination;
Administration of any inactivated vaccine within 14 days prior to enrolment or if receipt of another inactivated vaccine is expected within 14 days of any study vaccination;
Receipt of any blood product within 90 days prior to vaccination or expected receipt during this study;
Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site as a parent/guardian)
Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluation of the vaccines.

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

Research Site
Kameyama-shi
Research Site
Suzuka-shi
Research Site
Tsu

Other trials in Japan

About this study

Read the detailed description

For children age 2 years through 6 years, the recommended dosage schedule for intranasal administration is 0.2 mL (0.1 mL per nostril). For children not previously vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.

For the safety and tolerability endpoint, data will be gathered on solicited symptoms, AEs and SAEs.

Conditions: Healthy Japanese Children Age 2 Years Through 6 Years
Being tested: MEDI3250
Keywords: Safety, Tolerability, MEDI3250, Japanese children

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI3250Drug
MEDI3250

Study groups in NCT02269488
Study group	Role	What they receive
MEDI3250	Experimental	MEDI3250 Nasal spray Receives: Drug: MEDI3250

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250
Solicited symptoms experienced from administration of investigational product through 14 days post vaccination by dose number.
Solicited symptoms are events that are considered likely to occur post dosing. For this study, solicited symptoms include "Fever ≥ 100.4°F (38.0°C) by any route", "Runny/stuffy nose", "Sore throat", "Cough", "Headache", "Generalized muscle aches", "Decreased activity level (lethargy) or tiredness/weakness", "Decreased appetite" and "Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) will be omitted when, according to the judgment of the investigator, the subject is too young to reliably report a particular symptom"
Measured: 14 days post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Feb 2015

First posted21 Oct 2014 (estimated)
Study startNov 2014
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy Japanese Children Age 2 Years Through 6 YearsStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02269488
Sponsor's protocol ID: D2560C00007
Status last verified: Aug 2015
First submitted: 13 Oct 2014
Last updated: 28 Sep 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years
ClinicalTrials.gov ID: NCT02269488
Acronym / sponsor ID: D2560C00007
Conditions: Healthy Japanese Children Age 2 Years Through 6 Years
Keywords: Safety, Tolerability, MEDI3250, Japanese children
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 21 Oct 2014 (estimated)
Results: Posted 28 Sep 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

For the safety and tolerability endpoint, data will be gathered on solicited symptoms, AEs and SAEs.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MEDI3250	Experimental	Drug: MEDI3250MEDI3250 Nasal spray

Who may qualify

Ages: 2 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year.
Age 2 through 6 years of age at the time of administration.
A written informed consent should be obtained from the subject's legally acceptable representative.
Ability of the parent/guardian to understand and comply with the requirements of the protocol．
Parent/guardian available by telephone or email．

Key exclusion criteria (17 listed)

Previous administration in the present study
Participation in another clinical study with an investigational product during the last 3 month
Acute illness or evidence of significant active infection at time of investigational product administration
Fever ≥99.5°F (37.5°C) at time of investigational product administration
Any drug therapy from 15 days prior to randomization or expected drug therapy through 28 days post last dose with the exception of the following classes/types of medications, which are allowed:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MEDI3250MEDI3250	Drug	MEDI3250

Primary outcome

Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250
Time frame: 14 days post vaccination
Solicited symptoms experienced from administration of investigational product through 14 days post vaccination by dose number. Solicited symptoms are events that are considered likely to occur post dosing. For this study, solicited symptoms include "Fever ≥ 100.4°F (38.0°C) by any route", "Runny/stuffy nose", "Sore throat", "Cough", "Headache", "Generalized muscle aches", "Decreased activity level (lethargy) or tiredness/weakness", "Decreased appetite" and "Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) will be omitted when, according to the judgment of the investigator, the subject is too young to reliably report a particular symptom"

Results and safety

Results posted to the registry on 28 Sep 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MEDI3250	100	100

Primary outcome: Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250

Time frame: 14 days post vaccination. Number. Unit: subjects

Measure	MEDI3250 n = 100
Value	57

Adverse events

Time frame: From administration of investigational product through 28 days post vaccination by dose number. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MEDI3250	0 of 100 (0%)	13 of 100 (13%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shigeru Suga, MD principal investigator

National Mie Hospital

Ochiai Hitoshi, MD principal investigator

Ochiai Pediatrics Clinic

Watanabe Masahiro, MD principal investigator

Suzuka Pediatrics Clinic

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MEDI3250 in people with Healthy Japanese Children Age 2 Years Through 6 Years, run by AstraZeneca at 3 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250 (time frame: 14 days post vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02269488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.