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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02269488
Recruitment Status : Completed
First Posted : October 21, 2014
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Healthy Japanese Children Age 2 Years Through 6 Years
Intervention Drug: MEDI3250
Enrollment 100
Recruitment Details

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.
Pre-assignment Details  
Arm/Group Title MEDI3250
Hide Arm/Group Description MEDI3250 was administered to all subjects.
Period Title: Overall Study
Started 100
Completed 100
Not Completed 0
Arm/Group Title MEDI3250
Hide Arm/Group Description MEDI3250 was administered to all subjects.
Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
Safety analysis set
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
4.2  (1.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
55
  55.0%
Male
45
  45.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
100
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
American Indian or Alaska Native
0
   0.0%
Asian
100
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250
Hide Description

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"

Time Frame 14 days post vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MEDI3250
Hide Arm/Group Description:
MEDI3250 was administered to all subjects.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: subjects
57
Time Frame From administration of investigational product through 28 days post vaccination by dose number
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MEDI3250
Hide Arm/Group Description MEDI3250 was administered to all subjects.
All-Cause Mortality
MEDI3250
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MEDI3250
Affected / at Risk (%)
Total   0/100 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MEDI3250
Affected / at Risk (%)
Total   13/100 (13.00%) 
Infections and infestations   
Nasopharyngitis * 1  13/100 (13.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA, ver 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Raburn Mallory
Organization: MedImmune, LLC, a wholly-owned subsidiary of AstraZeneca PLC
Phone: +1 301-398-5799
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02269488     History of Changes
Other Study ID Numbers: D2560C00007
First Submitted: October 13, 2014
First Posted: October 21, 2014
Results First Submitted: July 30, 2015
Results First Posted: September 28, 2015
Last Update Posted: September 28, 2015