Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age
Lead Sponsor:
Green Cross Corporation
Conditions:
Influenza Vaccine
Eligibility:
All Genders
6-35 years
Phase:
PHASE3
Brief Summary
If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Formed, study subjects eligible for participating this trial protocol were as...
Detailed Description
1. Part 1 If study subject's legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form, study subjects eligible for participating this trial protocol...
Eligibility Criteria
Inclusion
- Healthy infants aged 6 month to 3 years.
- Study subject was born at full term pregnancy(37 week)
- Study subject who understand the details of this clinical trial, decide voluntarily to participate the trial, and signed the Informed Consent Form
Exclusion
- Those with a history of allergic reaction to eggs or chicken, the vaccine components
- Those who had been ad ministered the influenza vaccine 6 months prior to the study drug vaccination
- Those with immunologic impairment including immune deficiency disorders or family history about it.
- Those with a history of Guillain-Barre syndrome
- Those with a history of Down's syndrome or cytogenetic disorders
- Those who would be ineligible to participate the study as follows: serious chronic disease
- Hemophilia patients at risk of serious bleeding with intramuscular injection or those receiving anticoagulant therapy
- Those who have active infection or who have fever higher than 38.0℃ within 72 hours prior to the dosing of study drug
- Those who had been vaccinated with another vaccine within 28 days prior to the dosing of study drug or had a scheduled vaccination during the clinical trial period
- Those who had received an immunosuppressant, immunity-modifying drug within 3 months prior to the dosing of study drug
- Those who had received immunoglobulin or a blood-derived product within 3 months prior to the dosing of study drug or is scheduled to receive those products during the study period
- Those who had taken antipyretic/analgesic/nonsteroidal antiinflammatory drugs within 4 hours prior to the dosing of study drug
- Study subject who had participated in other clinical trial within 28 days prior to the study vaccination
Key Trial Info
Start Date :
September 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2018
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT03285997
Start Date
September 30 2017
End Date
August 31 2018
Last Update
September 18 2017
Active Locations (1)
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1
The Catholic Univ.of Korea Seoul St.Mary's Hospital
Seoul, South Korea