A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age
1 other identifier
interventional
260
1 country
1
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 assigned to test group or control group with the ratio of 4:1 and receiving the test or control drug 1 time or 2 times.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2017
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2017
CompletedFirst Posted
Study publicly available on registry
September 18, 2017
CompletedStudy Start
First participant enrolled
September 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedSeptember 18, 2017
September 1, 2017
8 months
September 13, 2017
September 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Seroconversion rate for HI antibody after final injection
the percentage of study subjects with a pre-vaccination (Day 0) HI titer\<1:10 and post-vaccination (Day 28) HI antibody titer≥1:40(Case1), or the percentage of study subjects with a pre-vaccination HI antibody titer≥1:10 and a minimum four-fold rise in post-vaccination HI antibody titer(Case 2)
Post-vaccination (Day 28 or 56)
Seroprotection rate for HI antibody after final injection
Post-vaccination (Day 28 or 56)
Secondary Outcomes (2)
GMT
Post-vaccination (Day 28 or 56)
GMR
Post-vaccination (Day 28 or 56)
Study Arms (2)
GC3110A
EXPERIMENTALOne injection: Day 0 Two injection: Day 0 and Day 28
GCFLU Pre-filled syringe inj.
ACTIVE COMPARATOROne injection: Day 0 Two injection: Day 0 and Day 28
Interventions
A single 0.25mL dose intramuscular injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic Univ.of Korea Seoul St.Mary's Hospital
Seoul, South Korea
Related Publications (1)
Choi UY, Kim KH, Lee KY, Kim JH, Kim CS, Eun BW, Kim HM, Kim DH, Song SE, Jo DS, Lee J, Ma SH, Kim KN, Kang JH. Active-controlled phase III study of an egg-cultivated quadrivalent inactivated split-virion influenza vaccine (GC3110A) in healthy Korean children aged 6-35 months. Vaccine. 2021 Apr 8;39(15):2103-2109. doi: 10.1016/j.vaccine.2021.03.005. Epub 2021 Mar 16.
PMID: 33736920DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2017
First Posted
September 18, 2017
Study Start
September 30, 2017
Primary Completion
May 31, 2018
Study Completion
August 31, 2018
Last Updated
September 18, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share