Trial · NCT02269475
A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years
NCT02269475, Phase 3, Completed, AstraZeneca; results first posted 2015-12-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years. Trials, record NCT02269475. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02269475
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years
- NCT number
- NCT02269475
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,369 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Healthy Japanese Children Age 7 Years Through 18 Years
- Interventions
- MEDI3250, Placebo
- First posted
- 2014-10-21
- Last updated
- 2017-04-04
- Results first posted
- 2015-12-03
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain) | 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) |
| Secondary | the Incidence of Laboratory-confirmed Influenza Infection (Any Strain) | 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 (any strain) |
| Secondary | the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain) | 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, by strain) |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain) | through the end of the influenza surveillance period, up to end Apr (6 months) | Per Protocol Population | Participants | NUMBER |
| SECONDARY | the Incidence of Laboratory-confirmed Influenza Infection (Any Strain) | through the end of the influenza surveillance period, up to end Apr (6 months) | Participants | NUMBER | |
| SECONDARY | the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain) | through the end of the influenza surveillance period, up to end Apr (6 months) | Per Protocol Population | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain) | MEDI3250 | 0 | Participants | ||
| the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain) | Placebo | 1 | Participants | ||
| the Incidence of Laboratory-confirmed Influenza Infection (Any Strain) | MEDI3250 | 169 | Participants | ||
| the Incidence of Laboratory-confirmed Influenza Infection (Any Strain) | Placebo | 118 | Participants | ||
| the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain) | MEDI3250 | Strain A_H1N1 | 0 | Participants | |
| the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain) | Placebo | Strain A_H1N1 | 0 | Participants | |
| the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain) | MEDI3250 | Strain A_H3N2 | 0 | Participants | |
| the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain) | Placebo | Strain A_H3N2 | 0 | Participants | |
| the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain) | MEDI3250 | Strain B_Yamagata | 0 | Participants | |
| the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain) | Placebo | Strain B_Yamagata | 1 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MEDI3250 | 868 | |
| Overall Study | STARTED | Placebo | 433 | |
| Overall Study | Received IP (Safety Population) | MEDI3250 | 868 | |
| Overall Study | Received IP (Safety Population) | Placebo | 433 | |
| Overall Study | Per Protocol Population | MEDI3250 | 849 | |
| Overall Study | Per Protocol Population | Placebo | 430 | |
| Overall Study | COMPLETED | MEDI3250 | 865 | |
| Overall Study | COMPLETED | Placebo | 432 | |
| Overall Study | NOT COMPLETED | MEDI3250 | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events36
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nasopharyngitis | Infections and infestations | MEDI3250 | 70 | 868 | 70 |
| other | nasopharyngitis | Infections and infestations | Placebo | 36 | 433 | 36 |
| other | nasopharyngitis | Infections and infestations | Total Number | 106 | 1,301 | 106 |
| other | rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MEDI3250 | 14 | 868 | 14 |
| other | rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Placebo | 9 | 433 | 9 |
| other | rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Total Number | 23 | 1,301 | 23 |
| other | upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MEDI3250 | 18 | 868 | 18 |
| other | upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | Placebo | 8 | 433 | 8 |
| other | upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | Total Number | 26 | 1,301 | 26 |
| other | Bronchitis | Infections and infestations | MEDI3250 | 5 | 868 | 5 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MEDI3250 | ||
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Total Number | ||
| Total, other adverse events | MEDI3250 | 126 | 868 |
| Total, other adverse events | Placebo | 67 | 433 |
| Total, other adverse events | Total Number | 193 | 1,301 |
| Total, serious adverse events | MEDI3250 | 3 | 868 |
| Total, serious adverse events | Placebo | 3 | 433 |
| Total, serious adverse events | Total Number | 6 | 1,301 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MEDI3250 vs Placebo: the Incidence of Laboratory-confirmed Influenza Infection (Any Strain) | Trial comparisons |
| MEDI3250 vs Placebo: the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02269475
GET https://conductscience.org/api/trials/v1/NCT02269475/events?page=2