Status unknownNCT03285997Updated Sep 18, 2017

A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age

A Phase 3 interventional study of GC3110A and GCFLU Pre-filled syringe inj. in Influenza Vaccine, sponsored by Green Cross Corporation. Status unknown at 1 site in Korea, Republic of. Open to participants aged 6 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by Green Cross Corporation · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 260
Allocation: Randomized
Ages: 6 Months to 35 Months
Sex: All

Study 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.

Read the detailed description

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 were assigned to test group and receiving the test drug 1 time or 2 times.
Part 2 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.

The investigator will evaluate the efficacy and safety of the test product while clinical trial.

Blood samples will be collected at visit 1 and visit 5 for immunogenicity evaluation. The study subject and their legal guardians will be educated to daily record AEs after vaccination on the patient diary to evaluate the safety.

At visit1, blood samples will be collected from randomized study subjects and investigational drug will be intramuscularly injected. However, those who had not been vaccinated with influenza vaccine, will re-visit and have the 2nd vaccination, 4\~5 weeks after the 1st vaccination.

After 4\~5 weeks since last vaccination, study subjects will visit and blood sample will be collected. And the serious adverse events occurred during 180 days after the final vaccination will be checked through the telephone visit.

The study subjects with 1 dose of vaccine will have 4 visits including Visit 1\~2 and Visit 5\~6. The study subjects with 2 dose of vaccine will have 6 visits including Visit 3\~4.

Conditions studied

Influenza Vaccine

Browse trials for

Influenza, Human 2,209

Keywords

Quadrivalent Influenza Vaccines

Who can participate

Ages eligible: 6 Months to 35 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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 criteria

Exclusion Criteria:

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

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 260 participants (estimated)

Study arms

Experimental
GC3110A
One injection: Day 0 Two injection: Day 0 and Day 28
Biological: GC3110A
Active comparator
GCFLU Pre-filled syringe inj.
One injection: Day 0 Two injection: Day 0 and Day 28
Biological: GCFLU Pre-filled syringe inj.

Interventions

BiologicalGC3110A
A single 0.5mL dose intramuscular injection
BiologicalGCFLU Pre-filled syringe inj.
A single 0.25mL dose intramuscular injection

What researchers measure

Primary outcomes

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)
Time frame: Post-vaccination (Day 28 or 56)
Seroprotection rate for HI antibody after final injection
Time frame: Post-vaccination (Day 28 or 56)

Secondary outcomes

GMT
GMT(Geometric Mean Titer) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)
Time frame: Post-vaccination (Day 28 or 56)
GMR
GMR(Geometric Mean Ratio) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)
Time frame: Post-vaccination (Day 28 or 56)

Study locations

1 site

The Catholic Univ.of Korea Seoul St.Mary's Hospital
Seoul, Korea, Republic of
- Jin Han Kang, M.D.PhD · Contact
- Jin Han Kang, M.D.PhD · Principal investigator

References and documents

Publications

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. PubMed 33736920 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03285997
Lead sponsor: Green Cross Corporation
Responsible party: Sponsor
First posted: Sep 18, 2017
Start date: Sep 30, 2017 (estimated)
Primary completion: May 31, 2018 (estimated)
Completion: Aug 31, 2018 (estimated)
Last update: Sep 18, 2017

Study contacts

Han-A Cha

Contact

hacha@greencross.com

+82-260-1936

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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