A Phase 3, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MEDI3250 Compared to Placebo in Healthy Japanese Children age 2 years through 18 years

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223345

Enrollment

782

Registered

2016-10-11

Start date

2016-10-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis of influenza infection

Interventions

investigational material(s) Generic name etc : MEDI3250 INN of investigational material : Therapeutic category code : 631 Vaccines Dosage and Administration for Investigational material : Intranasal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Healthy Japanese Children age 2 years through 18 years at the time of informed consent. 2) The ability of the subject to give to comply with study procedures and performed any study-specific procedure, to offer any symptom.

Exclusion criteria

Exclusion criteria: 1) Administration of any influenza virus vaccine within 6 months prior to informed consent. 2) Use of antiviral agents with activity against influenza virus within 28 days prior to informed consent.

Design outcomes

Primary

Measure	Time frame
1)Efficacy The incidence of laboratory-confirmed symptomatic influenza infection caused by any community-acquired wild-type strains regardless of match to the vaccine. 2) Safety Incidence of treatment-emergent adverse events -Solicited adverse events for 14 days post vaccination -Adverse events for 28 days post vaccination -Serious adverse events from informed consent until the end of the study. The endpoint is evaluated by constructing a 2-sided 95% exact confidence interval for the risk reduction of MEDI3250 compared to placebo.	—

Measure

Time frame

1)Efficacy The incidence of laboratory-confirmed symptomatic influenza infection caused by any community-acquired wild-type strains regardless of match to the vaccine. 2) Safety Incidence of treatment-emergent adverse events -Solicited adverse events for 14 days post vaccination -Adverse events for 28 days post vaccination -Serious adverse events from informed consent until the end of the study. The endpoint is evaluated by constructing a 2-sided 95% exact confidence interval for the risk reduction of MEDI3250 compared to placebo.

—

Secondary

Measure	Time frame
The incidence of wild type influenza infection from the genotyping test, caused by vaccine-matched strain in the influenza surveillance period. The endpoint is evaluated by constructing a 2-sided 95% exact confidence interval for the risk reduction of MEDI3250 compared to placebo.	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026