Influenza, HumanPhase 4NCT02723812
Evaluate Safety of GCFLU® Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old
A Phase 4 study testing GCFLU® Influenza vaccine (Split virion, Inactivated) in people with Influenza, Human, run by Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products at 1 site in Vietnam.
Trial summary
An open label, non-comparative bridging study to evaluate the safety of GCFLU® (seasonal influenza vaccine) administered intramuscularly in healthy Vietnamese volunteer aged from 3 years old Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- GCFLU® Influenza vaccine (Split virion, Inactivated)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteVietnam
- Study dates
- Nov 2015to Dec 2015
- Phase
- Phase 4
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject must meet all criteria below to participate in study
- A person who is a 3-year-old or older, healthy and can be followed up for 21 days
- Subject who gave voluntary written consent to participate in the study, and able to comply with the study requirements. With subjects aged from 3 years to below 18 years, parents/legal representative will give voluntary consent to participate in this study, and subjects from 12 to under 18 years old will give voluntary written consent for children.
Who cannot join
- Subject have one of criteria below must not participate in study
- Subject with a known hypersensitivity or allergic reaction to eggs or eggs products, to chicken or chicken products, to any component of the study vaccine, neomycin or gentamicin.
- Subjects with immune system disorder including immune deficiency disease.
- Subjects with a history of Guillain-Barre syndrome.
- Subjects with severe chronic disease (e.g.; cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal/kidney dysfunction or hemoglobinopathy etc.) who in the investigator's opinion may have a difficulty in participating in the study.
- Subjects with hemophilia or receiving a treatment with an anticoagulant, who are at increased risk of serious bleeding during intramuscular injection.
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- Subject who had acute fever with body temperature exceeding 37.50 Celsius (armpit calculated) before vaccination with the study drug.
- Subjects who had received other vaccination within 14 days before vaccination with the study drug, or those who had another vaccination scheduled during the study.
- Pregnant women, breast-feeding women or women of childbearing potential who do not use an appropriate method of contraception (use of condom, intrauterine contraceptive device, or hormone contraceptives, or of a male partner had vasectomy).
- Subjects who had participated in other clinical study within 28 days priors to vaccination with the study drug, or those who had another clinical trial scheduled during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Bridging Study to Evaluate Safety of GCFLU® One Dose (0.5ml) (Seasonal Influenza Vaccine) Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old
An open label, non-comparative bridging study to evaluate the safety of GCFLU® (seasonal influenza vaccine) administered intramuscularly in healthy Vietnamese volunteer aged from 3 years old
Read the detailed description
A bridging study to evaluate safety of seasonal influenza vaccine GCFLU® pre-filled syringe inj. One dose (0.5 ml) after exposure administered intramuscularly. The study conducted in Ben Luc District of Long An province, in which 120 healthy Vietnamese volunteer aged from 5 year old will be enroll to the study. All subject will receive only one dose (0.5 ml) vaccine in Day 0.
Study variables will be collected to determine and provide the evidence for the safety of GCFLU®, include:
- Local and systemic adverse event (AE) in 30 minutes after vaccination.
- Local and systemic AE in 7 days after vaccination
- Unsolicited AE over 21 days after vaccination.
- Serious adverse event (SAE) after vaccination and in 21 days of observation periods Study protocol has been reviewed and approved by Pasteur Institute in Ho Chi Minh City (HCMC) Institutional Review Board (IRB), Vietnam Ministry of Health - Independent Ethics Committee (IEC) and Vietnam Minister of Health.
- Conditions
- Influenza, Human
- Being tested
- GCFLU® Influenza vaccine (Split virion, Inactivated)
- Keywords
- Influenza, GCFLU, vaccine, Vietnam
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCFLU® Influenza vaccine (Split virion, Inactivated)Biological
Also called GCFLU® pre-filled syringe inj.
| Study group | Role | What they receive |
|---|---|---|
| GCFLU® Influenza vaccine (Split virion, Inactivated) | Experimental | One dose 0.5 mL vaccine GCFLU® administered intramuscularly. Receives: Biological: GCFLU® Influenza vaccine (Split virion, Inactivated) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general).
Measured: 30 minutes after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of solicited adverse events (local and general)
Measured: For 7 days after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of unsolicited adverse events.
Measured: During 21 days after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of serious adverse events.
Measured: During 21 days after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
- Sponsor type
- University, hospital or other
- Collaborators
- Green Cross Corporation
- Responsible party
- Principal investigator, Nguyen Vu Thuong, Pasteur Institute, Ho Chi Minh City
- Investigators
- Thuong Nguyen Vu, PhD., Principal investigator, Pasteur Institute, Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723812
- Sponsor's protocol ID
- VX-2015.02
- Status last verified
- Mar 2016
- First submitted
- 22 Feb 2016
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bridging Study to Evaluate Safety of GCFLU® One Dose (0.5ml) (Seasonal Influenza Vaccine) Administered Intramuscularly in Healthy Vietnamese Volunteer Aged From 3 Years Old
- ClinicalTrials.gov ID
- NCT02723812
- Acronym / sponsor ID
- VX-2015.02
- Conditions
- Influenza, Human
- Keywords
- Influenza, GCFLU, vaccine, Vietnam
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological ProductsUniversity, hospital or other
- Collaborators
- Green Cross Corporation
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Mar 2016 (estimated)
- 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.
An open label, non-comparative bridging study to evaluate the safety of GCFLU® (seasonal influenza vaccine) administered intramuscularly in healthy Vietnamese volunteer aged from 3 years old
Detailed description
A bridging study to evaluate safety of seasonal influenza vaccine GCFLU® pre-filled syringe inj. One dose (0.5 ml) after exposure administered intramuscularly. The study conducted in Ben Luc District of Long An province, in which 120 healthy Vietnamese volunteer aged from 5 year old will be enroll to the study. All subject will receive only one dose (0.5 ml) vaccine in Day 0.
Study variables will be collected to determine and provide the evidence for the safety of GCFLU®, include:
- Local and systemic adverse event (AE) in 30 minutes after vaccination.
- Local and systemic AE in 7 days after vaccination
- Unsolicited AE over 21 days after vaccination.
- Serious adverse event (SAE) after vaccination and in 21 days of observation periods Study protocol has been reviewed and approved by Pasteur Institute in Ho Chi Minh City (HCMC) Institutional Review Board (IRB), Vietnam Ministry of Health - Independent Ethics Committee (IEC) and Vietnam Minister of Health.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GCFLU® Influenza vaccine (Split virion, Inactivated) | Experimental | Biological: GCFLU® Influenza vaccine (Split virion, Inactivated)One dose 0.5 mL vaccine GCFLU® administered intramuscularly. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must meet all criteria below to participate in study
- A person who is a 3-year-old or older, healthy and can be followed up for 21 days
- Subject who gave voluntary written consent to participate in the study, and able to comply with the study requirements. With subjects aged from 3 years to below 18 years, parents/legal representative will give voluntary consent to participate in this study, and subjects from 12 to under 18 years old will give voluntary written consent for children.
Key exclusion criteria (10 listed)
- Subject have one of criteria below must not participate in study
- Subject with a known hypersensitivity or allergic reaction to eggs or eggs products, to chicken or chicken products, to any component of the study vaccine, neomycin or gentamicin.
- Subjects with immune system disorder including immune deficiency disease.
- Subjects with a history of Guillain-Barre syndrome.
- Subjects with severe chronic disease (e.g.; cardiovascular disease except for controlled hypertension, respiratory disease, metabolic disease, renal/kidney dysfunction or hemoglobinopathy etc.) who in the investigator's opinion may have a difficulty in participating in the study.
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 |
|---|---|---|
| GCFLU® Influenza vaccine (Split virion, Inactivated)Also: GCFLU® pre-filled syringe inj. | Biological | GCFLU® Influenza vaccine (Split virion, Inactivated) |
Primary outcome
Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general).
Time frame: 30 minutes after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of solicited adverse events (local and general)
Time frame: For 7 days after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of unsolicited adverse events.
Time frame: During 21 days after vaccination.
Safety of GCFLU® by assessing the frequency, rate and severity of serious adverse events.
Time frame: During 21 days after vaccination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
Thuong Nguyen Vu, PhD. principal investigator
Pasteur Institute, Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GCFLU® Influenza vaccine (Split virion, Inactivated) in people with Influenza, Human, run by Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products at 1 site in Vietnam.
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 10 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 30 Mar 2016. 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 Vietnam. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Safety of GCFLU® by assessing the frequency, rate and severity of adverse events (local and general). (time frame: 30 minutes after vaccination.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2016.