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InfluenzaPhase 3NCT02541253

A Study to Evaluate the Efficacy and Safety of 'GC3110A(QIV)' in Healthy Children

A Phase 3 study testing GC3110A and GCFLU Pre-filled Syringe inj. in people with Influenza, run by Green Cross Corporation at 12 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

1. Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form (In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), study subjects eligible for participating this trial protocol… Read more about this study

Who is it for?
Ages 6 months to 19 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
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
543 participants
Where
12 sitesSouth Korea
Study dates
Sep 2015to Jun 2016
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 months to 19 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy infants and adolescents aged 6 month to 19 years
  • study Subject was born at full term pregnancy(37 weeks)
  • study Subject who understand the details of this clinical trial, decide voluntarily to participate the trial, and signed the Informed Consent Form (less than 7 years of age, written informed consent by study subject's legal guardians)

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 (cardiovascular system disease; excluding controlled hypertension and respiratory system disease; including respiratory failure, metabolic disease, renal dysfunction, hemoglobinopathy, etc)
Show all 14Show 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 - (1) Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc., (2) Those receiving high dose of corticosteroid(15mg/day of prednisolone is acceptable, but study subject used consistently 2mg/kg more than 14days is considered a high dose, so excluded in this clinical trial. However, inhalated, intra nasal and topical administration is acceptable regardless of dose.
  • 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
  • Those whose clinically significant medical or psychiatric condition at the discretion of the investigator that would be ineligible to participate the study

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • Changwon Fatima Hospital

    Changwon

  • Keimyung University Dongsan Medical Center

    Daegu

  • The Catholic Univ. of Korea Daejeon St. Mary's Hospital

    Daejeon

  • Chonnam National University Hospital

    Gwangju

  • Inha University Hospital

    Incheon

  • Chonbuk National University Hospital

    Jeonju

  • Eulji University Medical Center

    Seoul

  • Kepco Medical Center

    Seoul

  • Korea Cancer Center Hospital

    Seoul

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul

  • The Catholic Univ. of Korea St. Vincent's Hospital

    Suwon

  • Wonju Severance Christian Hospital

    Wŏnju

Other trials in South Korea

About this study

Official title: An Open-label(Part1), Single Arm(Part1), Randomized(Part2), Double-blind(Part2), Active-controlled(Part2), Phase III Study to Evaluate the Efficacy and Safety of 'GC3110A(QIV)' in Healthy Children

  1. Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form (In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 times or 2 times according to age.
  2. Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form(In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), the 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 drug 1 times or 2 times according to age as below;
  • 6 m ~ 3 years
  • 3 years ~ 9 years
  • 9 years ~ 19 years
Read the detailed description
  1. Part 1 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form (In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), study subjects eligible for participating this trial protocol were assigned to test group and receiving the test drug 1 times or 2 times according to age. The safety data collected during part A will be reviewed by DSMB to evaluate the solicited adverse events for 7 days after each vaccination. However, if no toxicity higher than grade 3 according to FDA guidance the study was allowed to proceed to Part 2 without DSMB review. Efficacy and safety assessment methods, and visiting schedule will be the same as Part 2.
  2. Part 2 If study subject and legal guardians who decide voluntarily to participate the clinical trial, and sign the Informed Consent Form(In the case of study subject less than 7 years of age, written informed consent by study subject's legal guardians), the 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 drug 1 times or 2 times according to age as below;
  • 6 m ~ 3 years
  • 3 years ~ 9 years
  • 9 years ~ 19 years The investigator will evaluate the efficacy and safety of the test product while clinical trial.

Blood samples will be collected at visit 1 for efficacy 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 of doses of 0.25mL or 0.5mL according to age will be intramuscularly injected. However, those who had not been vaccinated with influenza vaccine, aged of over than 6 months to less than 9 years study subjects, 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 1~2, Visit 3~4 and Visit 5~6.

Conditions
Influenza
Being tested
GC3110A, GCFLU Pre-filled Syringe inj.
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 0.5mL dose intramuscular injection

Study groups in NCT02541253
Study groupRoleWhat they receive
GC3110AExperimentalOne injection : 0.5ml or 0.25ml, IM on day 0 Two injection : 0.5ml or 0.25ml, IM on day 0
Receives: Biological: GC3110A
GCFLU Pre-filled Syringe inj.Active comparatorOne injection : 0.5ml or 0.25ml, IM on day 0 Two injection : 0.5ml or 0.25ml, IM on day 0
Receives: Biological: GCFLU Pre-filled Syringe inj.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The percentage of study subjects achieving seroconversion* for HI antibody(seroconversion rate) The percentage of study subjects achieving a post-vaccination HI antibody titer≥1:40 (seroprotection rate)

    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)

Secondary outcomes (4)

  1. GMT

    GMT (Geometric Mean Titer) of HI antibody titer before vaccination (Day 0) and after vaccination (Day 28)

    Measured: Post-vaccination (Day 28)

  2. GMR

    GMR (Geometric Mean Ratio) of HI antibody titer before vaccination (Day 0) and after vaccination (Day 28)

    Measured: Post-vaccination (Day 28)

  3. The solicited adverse events (7 days after vaccination)

    The presence of the solicited adverse events occurred during 7 days after vaccination Local reaction: pain, tenderness, erythema/redness, induration/swelling Systemic reaction: fever, sweating, chills, nausea/vomiting, diarrhea, fatigue/malaise, headache, myalgia, arthralgia

    Measured: Post-vaccination (Day 7)

  4. The unsolicited adverse events (28 days after vaccination)

    The presence of the unsolicited adverse events occurred during 28 days after the study vaccination

    Measured: Post-vaccination (Day 28)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionJun 2016
  4. Study completionJun 2016

Resources

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
543 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02541253
Sponsor's protocol ID
GC3110A_C_P3
Status last verified
Nov 2016
First submitted
28 Aug 2015
Last updated
7 Nov 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Lee J, Lee KY, Kim JH, Kim CS, Eun BW, Kim HM, Kim DH, Hong YJ, Choi YY, Jo DS, Ma SH, Kang JH. Safety and Immunogenicity of an Egg-Cultivated Quadrivalent Inactivated Split-virion Influenza Vaccine (GC3110A) in Healthy Korean Children: a Randomized, Double-blinded, Active-controlled Phase III Study. J Korean Med Sci. 2018 Mar 26;33(13):e100. doi: 10.3346/jkms.2018.33.e100.

    PubMed 29573247

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, run by Green Cross Corporation at 12 sites 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 14 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: finished, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage of study subjects achieving seroconversion* for HI antibody(seroconversion rate) The percentage of study subjects achieving a post-vaccination HI antibody titer≥1:40 (seroprotection rate) (time frame: Post-vaccination (Day 28)). 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 NCT02541253, 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 7 Nov 2016.

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