Influenza VaccinePhase 3NCT03285997
A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age
A Phase 3 study testing GC3110A and GCFLU Pre-filled syringe inj. in people with Influenza Vaccine, run by Green Cross Corporation at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccine
- What is being tested?
- GC3110A and GCFLU Pre-filled syringe inj.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Sep 2017to 31 Aug 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic Univ.of Korea Seoul St.Mary's Hospital
Seoul
Jin Han Kang, M.D.PhD
Jin Han Kang, M.D.PhD
About this study
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
- Influenza Vaccine
- Being tested
- GC3110A, GCFLU Pre-filled syringe inj.
- Keywords
- Quadrivalent Influenza Vaccines
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC3110ABiological
A single 0.5mL dose intramuscular injection
GCFLU Pre-filled syringe inj.Biological
A single 0.25mL dose intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| GC3110A | Experimental | One injection: Day 0 Two injection: Day 0 and Day 28 Receives: Biological: GC3110A |
| GCFLU Pre-filled syringe inj. | Active comparator | One injection: Day 0 Two injection: Day 0 and Day 28 Receives: Biological: GCFLU Pre-filled syringe inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Post-vaccination (Day 28 or 56)
Seroprotection rate for HI antibody after final injection
Measured: Post-vaccination (Day 28 or 56)
Secondary outcomes (2)
GMT
GMT(Geometric Mean Titer) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)
Measured: Post-vaccination (Day 28 or 56)
GMR
GMR(Geometric Mean Ratio) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)
Measured: Post-vaccination (Day 28 or 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start30 Sep 2017 (estimated)
- Primary completion31 May 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285997
- Sponsor's protocol ID
- GC3110A_IF_P3
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2017
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age
- ClinicalTrials.gov ID
- NCT03285997
- Acronym / sponsor ID
- GC3110A_IF_P3
- Conditions
- Influenza Vaccine
- Keywords
- Quadrivalent Influenza Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2017 (estimated)
- Primary completion
- 31 May 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 18 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC3110A | Experimental | Biological: GC3110AOne injection: Day 0 Two injection: Day 0 and Day 28 |
| GCFLU Pre-filled syringe inj. | Active comparator | Biological: GCFLU Pre-filled syringe inj.One injection: Day 0 Two injection: Day 0 and Day 28 |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC3110AA single 0.5mL dose intramuscular injection | Biological | GC3110A |
| GCFLU Pre-filled syringe inj.A single 0.25mL dose intramuscular injection | Biological | GCFLU Pre-filled syringe inj. |
Primary outcome
Seroconversion rate for HI antibody after final injection
Time frame: Post-vaccination (Day 28 or 56)
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)
Seroprotection rate for HI antibody after final injection
Time frame: Post-vaccination (Day 28 or 56)
2 secondary outcomes
GMT
Time frame: Post-vaccination (Day 28 or 56)
GMR
Time frame: Post-vaccination (Day 28 or 56)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Derived from this study: PubMed 33736920Choi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GC3110A and GCFLU Pre-filled syringe inj. in people with Influenza Vaccine, run by Green Cross Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han-A Cha (+82-260-1936, hacha@greencross.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate for HI antibody after final injection (time frame: Post-vaccination (Day 28 or 56)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03285997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.