Healthy Japanese Children Age 7 Years Through 18 YearsPhase 3NCT02269475

A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years

A Phase 3 study testing MEDI3250 in people with Healthy Japanese Children Age 7 Years Through 18 Years, run by AstraZeneca at 38 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

The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 to 18 years of age that would support approval of MEDI3250 in Japan. Read more about this study

Who is it for?: Ages 7 to 18 years
Conditions the study is for: Healthy Japanese Children Age 7 Years Through 18 Years
What is being tested?: MEDI3250
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,369 participants
Where: 38 sitesJapan
Study dates: Oct 2014to Apr 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 7 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Age 7 through 18 years of age at the time of randomization.
A written informed consent should be obtained from the subject's legally acceptable representative, and a written informed assent should be obtained from the subject if possible.
Available for illness visits at clinic during the influenza surveillance period.
Ability of the legal representative to understand and comply with the requirements of the protocol．
Parent/guardian available by telephone, email or etc．
Females of childbearing potential, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), has sterile male partner, is premenarchal, or practices abstinence, must have used an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap with spermicide, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 60 days after the final dose of investigational product.
A subject who is considered by the investigator to be at risk of pregnancy must also have a negative urine pregnancy test at screening and, if screening and Day 0 do not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment is required to assess each subject's need for pregnancy testing.
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.

Who cannot join

Subjects who were previously administered influenza vaccine in 2014-2015 influenza season
Previous randomisation 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 randomization;
Fever ≥99.5°F (37.5°C) at randomization;
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:

Show all 19Show fewer

Contraceptives (change in contraceptive type or method is acceptable as long as guidelines are followed for prevention of pregnancy during change); 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.
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 randomization or expected receipt through the entire study;
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 in the study period;
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;
Pregnant or lactating female
Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site as a legal representative)
Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluation of the vaccines.

Trial locations and contacts

38 sites in 1 country.

City, postcode or hospital

38 sites in 1 country

Japan38 sites

Research Site
Akashi-shi
Research Site
Chofu-shi
Research Site
Fuchu-shi
Research Site
Fujimi-shi
Research Site
Fukui-shi
Research Site
Fukuoka
Research Site
Fukuroi-shi
Research Site
Funabashi-shi
Research Site
Gifu
Research Site
Hatsukaichi-shi
Research Site
Hiroshima
Research Site
Ichikawa-shi
Research Site
Isumi
Research Site
Iwate-gun
Research Site
Katsushika-ku
Research Site
Kawasaki-shi
Research Site
Kisarazu-shi
Research Site
Kiyose-shi
Research Site
Kobe
Research Site
Koga-shi
Research Site
Kumamoto
Research Site
Kunitachi-shi
Research Site
Kuwana-shi
Research Site
Matsudo-shi
Research Site
Minatoku
Research Site
Morioka
Research Site
Nakano
Research Site
Okayama
Research Site
Ōta-ku
Research Site
Sapporo
Research Site
Sendai
Research Site
Setagaya-ku
Research Site
Shinjuku-ku
Research Site
Shizuoka
Research Site
Taito-ku
Research Site
Toshima-ku
Research Site
Tsu
Research Site
Yokkaichi-shi

Other trials in Japan

About this study

Official title: A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MEDI3250 Compared to Placebo in Healthy Japanese Children Age 7 Years Through 18 Years

The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 to 18 years of age that would support approval of MEDI3250 in Japan.

Read the detailed description

This randomized, double-blind, placebo controlled, multicenter study will enrol 1008 subjects. The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 through 18 years of age that would support approval of MEDI3250 in Japan.

For children age 7 years through 18 years, the recommended dosage schedule for intranasal administration is 0.2 mL (0.1 mL per nostril). For children age 7 years through 8 years not previously vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.

For the efficacy endpoint, data will be gathered on the incidence of laboratory-confirmed influenza-like illness in the two treatment arms. Laboratory-confirmed influenza-like illness would include cases of influenza diagnosed using culture-confirmation and/or PCR-based methods.

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

Subject will be randomized 2:1 to receive MEDI3250 or placebo.

Conditions: Healthy Japanese Children Age 7 Years Through 18 Years
Being tested: MEDI3250, Placebo
Keywords: Efficacy, 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
PlaceboDrug
Placebo

Study groups in NCT02269475
Study group	Role	What they receive
MEDI3250	Experimental	MEDI3250 Nasal Spray Receives: Drug: MEDI3250
Placebo	Placebo comparator	Placebo Nasal spray Receives: Drug: Placebo

What is being measured

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

the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain)
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)
Measured: through the end of the influenza surveillance period, up to end Apr (6 months)

Secondary outcomes (2)

the Incidence of Laboratory-confirmed Influenza Infection (Any Strain)
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (any strain)
Measured: through the end of the influenza surveillance period, up to end Apr (6 months)
the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain, by strain)
Measured: through the end of the influenza surveillance period, up to end Apr (6 months)

Timeline

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

Oct 2014Apr 2015

First posted21 Oct 2014 (estimated)
Study startOct 2014
Primary completionApr 2015
Study completionApr 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 7 Years Through 18 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,369 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02269475
Sponsor's protocol ID: D2560C00006
Status last verified: Feb 2017
First submitted: 13 Oct 2014
Last updated: 4 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MEDI3250 Compared to Placebo in Healthy Japanese Children Age 7 Years Through 18 Years
ClinicalTrials.gov ID: NCT02269475
Acronym / sponsor ID: D2560C00006
Conditions: Healthy Japanese Children Age 7 Years Through 18 Years
Keywords: Efficacy, Safety, Tolerability, MEDI3250, Japanese children
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,369 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 21 Oct 2014 (estimated)
Results: Posted 3 Dec 2015

Clinical summary

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

The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 to 18 years of age that would support approval of MEDI3250 in Japan.

Detailed description

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

Subject will be randomized 2:1 to receive MEDI3250 or placebo.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
MEDI3250	Experimental	Drug: MEDI3250MEDI3250 Nasal Spray
Placebo	Placebo comparator	Drug: PlaceboPlacebo Nasal spray

Who may qualify

Ages: 7 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

Age 7 through 18 years of age at the time of randomization.
A written informed consent should be obtained from the subject's legally acceptable representative, and a written informed assent should be obtained from the subject if possible.
Available for illness visits at clinic during the influenza surveillance period.
Ability of the legal representative to understand and comply with the requirements of the protocol．
Parent/guardian available by telephone, email or etc．

Key exclusion criteria (19 listed)

Subjects who were previously administered influenza vaccine in 2014-2015 influenza season
Previous randomisation 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 randomization;
Fever ≥99.5°F (37.5°C) at randomization;

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
PlaceboPlacebo	Drug	Placebo

Primary outcome

the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain)
Time frame: through the end of the influenza surveillance period, up to end Apr (6 months)
The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)

2 secondary outcomes

the Incidence of Laboratory-confirmed Influenza Infection (Any Strain)
Time frame: through the end of the influenza surveillance period, up to end Apr (6 months)
the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)
Time frame: through the end of the influenza surveillance period, up to end Apr (6 months)

Results and safety

Results posted to the registry on 3 Dec 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	868	865
Placebo	433	432

Primary outcome: the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain)

Time frame: through the end of the influenza surveillance period, up to end Apr (6 months). Number. Unit: Participants

Measure	MEDI3250 n = 849	Placebo n = 430
Value	0	1

MEDI3250 vs Placebo: Vaccine efficacy (%): 100.0 (95% CI -1875.3 to 100.0), Exact conditional method

Population analysed: Per Protocol Population

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs experienced from administration of investigational product through 28 days post last vaccination were collected. Other adverse events reported at 0.01% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MEDI3250	3 of 868 (0.3%)	126 of 868 (14.5%)	Not reported
Placebo	3 of 433 (0.7%)	67 of 433 (15.5%)	Not reported
Total Number	6 of 1,301 (0.5%)	193 of 1,301 (14.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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.

Masaki Yokohama, MD principal investigator

Yokohama clinic

Toshiko Yamaguchi, MD principal investigator

Yamaguchi Clinic

Haruo Maeta, MD principal investigator

Maeta Pediatrics Clinic

38 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 7 Years Through 18 Years, run by AstraZeneca at 38 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 8 inclusion and 19 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 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 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. Some participants in this study may receive a placebo. 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 3 Dec 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?

the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain) (time frame: through the end of the influenza surveillance period, up to end Apr (6 months)). 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 NCT02269475.

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 4 Apr 2017.