Trial Outcomes & Findings for A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years (NCT NCT02269488)

Last Updated: 2015-09-28

Results Overview

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"

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

14 days post vaccination

Results posted on

2015-09-28

Participant Flow

In visit 1, 1. Obtain written informed consent. 2. Verify eligibility criteria. 3. Complete baseline procedures including a medical history and current medication use. 4. Perform physical examination . 5. Administer study products.

Participant milestones

Participant milestones
Measure	MEDI3250 MEDI3250 was administered to all subjects.
Overall Study STARTED	100
Overall Study COMPLETED	100
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MEDI3250 n=100 Participants MEDI3250 was administered to all subjects.
Age, Continuous	4.2 Years STANDARD_DEVIATION 1.4 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	100 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days post vaccination

Outcome measures

Outcome measures
Measure	MEDI3250 n=100 Participants MEDI3250 was administered to all subjects.
Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250	57 subjects

Adverse Events

MEDI3250

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MEDI3250 n=100 participants at risk MEDI3250 was administered to all subjects.
Infections and infestations Nasopharyngitis	13.0% 13/100 • From administration of investigational product through 28 days post vaccination by dose number

Additional Information

Raburn Mallory

MedImmune, LLC, a wholly-owned subsidiary of AstraZeneca PLC

Phone: +1 301-398-5799

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place