A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years
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|ClinicalTrials.gov Identifier: NCT02269488|
Recruitment Status : Completed
First Posted : October 21, 2014
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment||Phase|
|Healthy Japanese Children Age 2 Years Through 6 Years||Drug: MEDI3250||Phase 3|
For children age 2 years through 6 years, the recommended dosage schedule for intranasal administration is 0.2 mL (0.1 mL per nostril). For children not previously vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.
For the safety and tolerability endpoint, data will be gathered on solicited symptoms, AEs and SAEs.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Open-label Study to Evaluate the Safety of MEDI3250 in Healthy Japanese Children Age 2 Years Through 6 Years|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
MEDI3250 Nasal spray
- Number of Participants With Solicited Symptoms Experienced From Administration of MEDI3250 [ Time Frame: 14 days post vaccination ]
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"
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269488
|Principal Investigator:||Shigeru Suga, MD||National Mie Hospital|
|Principal Investigator:||Ochiai Hitoshi, MD||Ochiai Pediatrics Clinic|
|Principal Investigator:||Watanabe Masahiro, MD||Suzuka Pediatrics Clinic|