InfluenzaPhase 3NCT04695717

This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam

A Phase 3 study testing IVACFLU-S in people with Influenza, run by Vietnam Military Medical University at 2 sites in Vietnam.

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

This was an extensive, double-blind, randomized, placebo-controlled phase 3 study that aimed to evaluate the safety and immunogenicity of the seasonal inactivated, split virion, trivalent influenza vaccine (IVACFLU-S) in children from 6 months to under 18 years old and the elderly over 60 years old in Vietnam. Read more about this study

Who is it for?: Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: IVACFLU-S
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 864 participants
Where: 2 sitesVietnam
Study dates: 5 Sep 2020to 1 Apr 2022
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 and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Groups from 6 months to under 18 years:
Must have a sponsor (Father / Mother / Legal relative) and get the consent of the sponsor by signing a consent form to participate in the study. (Groups from 6 months to 8 years old must have a direct sponsor, groups 9-17 years old must have an indirect sponsor).
The sponsor must be able to read and write and must commit to taking the child or asking the child to visit on schedule.
If the Sponsor is not the child's parent, he/she must get the consent of the child's father/mother in writing.
Healthy or previous acute illness but stabilized within 2 weeks before injection.
No chronic disease (cancer, heart failure, kidney, liver ...) or chronic disease that has stabilized 3 months before injection.

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Children under 1 year old: Must have gestational age ≥ 37 and ≤ 42 weeks at birth and birth weight> 2500g and not have congenital disease.
Children <60 months of age are not severely malnourished (not exceeding I) Children 6 months to 8 years old who have never received a seasonal flu vaccine (from birth).
Female adolescents who are likely to become pregnant need to be informed of possible risks to the fetus if participating in the study and if participating in the study, must comply with contraceptive measures during the period. research.
Group over 60 years old
Can read, write (self-report) and ready to sign the consent form to participate in research.
Ability to participate in scheduled visits and adhere to all procedures of testing.
Be healthy or have a stable medical condition through history exploitation and physical examination. For subjects who have medical problems or symptoms/signs, the medical problems or symptoms/signs must be consistently controlled or unchanged within the past 3 months. If you are using medication to treat that medical problem, the dose should be stable for at least 1 month before the product is injected.
For female subjects who are still fertile:
Are not breastfeeding, or are not pregnant (based on a negative urine test) and are not planning to become pregnant until Day 22. For women who have not had sterilization surgery (hysterectomy or ligation fallopian tube) or menopause for less than a year must have a negative urine test and be ready to use effective contraception (intrauterine device, hormonal contraceptive, condom, vaginal diaphragm with spermicide) through visit Day 22

Who cannot join

Currently (within 2 weeks from the time of selection) with severe acute illness with or without fever.
Participation in another therapy-related clinical trial within the past 3 months or plan to participate in a similar clinical trial at the same time it is.
Use any other vaccine for 4 weeks prior to joining or refusing to delay vaccination of such vaccines until after the visit on Day 22 (for groups ≥ 9 years) or day 49 (with groups <9 years old).
Having been vaccinated against influenza in the past 11 months (only children 6 months to 8 years old who have been previously vaccinated with influenza vaccine (from birth) are also exclusion criteria).
Use immunoglobulins or other hematological products within 3 months prior to study enrollment or plan to use these products prior to day 22 visit (for groups ≥ 9 years) or day 49 (with groups <9 years old).
Suspected or certain acquired immunodeficiency.

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Long-term use (described as 14 consecutive days or more) immunosuppressants or other immunomodulatory therapies within 6 months prior to joining (for corticosteroids such as prednisone or substances similar to dose ≤ 0.5 mg / kg / day; topical steroids are allowed).
Through historical exploitation or physical examination, there is an unstable disease, but according to the researcher's assessment, this may affect the implementation or the results of the study or increase the risk for the participants. researcher.
Have experienced a previous hypersensitivity reaction after using any vaccine.
Certain or suspected hypersensitivity reaction to any ingredient of the studied vaccine, including chicken protein or chicken eggs and rubber (from the rubber cap of the vaccine vial).
Bleeding disorders or anticoagulant use within 3 weeks prior to selection. Have active TB or have symptoms of active tuberculosis, whatever the cause (self-reported).
Are currently addicted to alcohol or using drugs that, according to researchers' assessment, could affect their ability to comply with research protocols.
History of Guillain-Barré syndrome.
Cancer or any malignant blood disease.
Children under 1 year old but at birth with gestational age ≤ 36 and ≥ 43 weeks at birth and birthweight ≤ 2500g
Children <60 months old with severe malnutrition aged II and above

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

CDC Ha Nam
Phu Ly, Ha Nam, 18000
CDC Thai Binh
Thái Bình, 410000

Other trials in Vietnam

About this study

Official title: The Extensive, Double-blind, Randomized, Placebo-controlled Phase 3 Study to Evaluate the Safety and Immunogenicity of the Seasonal Inactivated, Split Virion, Trivalent Influenza Vaccine (IVACFLU-S) Produced in Children and the Elderly in Vietnam

The main target:

Evaluating the safety of the single or double dose of seasonal influenza vaccine (IVACFLU-S) in Vietnamese children aged 6 months to 17 years and adults over 60 years old.

Evaluating the immunogenicity of the seasonal inactivated, split virion, trivalent influenza vaccine (IVACFLU-S) after 1st injection on day 22 (+7) for groups ≥ 9 years old or day 49 (+7) for groups of 6 months to 8 years for each antigenic component of the vaccine.

Read the detailed description

The seasonal inactivated, split virion, trivalent influenza vaccine (TIV) were purified by the method of super centrifugation to create gradient segments in sucrose sugar produced by IVAC, or placebo produced by IVAC. Vaccines are produced on eggs, inactivated with formaldehyde. The dose of the vaccine tested was 15 mcg of HA for each antigen component in 0.5 ml. The influenza virus strains used to produce the 2020-2021 seasonal vaccine will also be provided by the NIBSC, which will be used according to WHO recommendations, which are expected to include the following Southern Hemisphere strains:

Influenza A / H1N1 strain: Recombinant strain IVR-190 44250 E12 of the strain (A / Brisbane / 02/2018).

Influenza strain A / H3N2: strain IVR-197 (H3N2) 44850 E14 recombinant strain (A / South Australia / 34/2019).

Flu strain B (B / Washington / February 2019). Extensive phase 3 was conducted 2 sites: District Health Center (DHC) of Vu Thu, Thai Binh, Vietnam; and DHC of Binh Luc, Ha Nam. Subjects were from two age groups: 6 months-under 18 years and over 60 years. Both safety and immunogenicity were assessed

Conditions: Influenza
Being tested: IVACFLU-S
Keywords: Influenza; vaccine; Seasonal influenza vaccine
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IVACFLU-SBiological
The Seasonal Inactivated, Split Virion, Trivalent Influenza Vaccine (TIV) were purified by the method of super centrifugation to create gradient segments in sucrose sugar produced by IVAC, or placebo produced by IVAC. Vaccines are produced on eggs, inactivated with formaldehyde. The dose of the vaccine tested was 15 mcg of HA for each antigen component in 0.5 ml.
The influenza virus strains used to produce the 2020-2021 seasonal vaccine will also be provided by the NIBSC, which will be used according to WHO's recommendation, which is expected to include the following Southern Hemisphere strains:
Influenza A / H1N1 strain: Recombinant strain IVR-190 44250 E12 of the strain (A / Brisbane / 02/2018).
Influenza strain A / H3N2: strain IVR-197 (H3N2) 44850 E14 recombinant strain (A / South Australia / 34/2019).
Flu strain B (B / Washington / February 2019).

Study groups in NCT04695717
Study group	Role	What they receive
Vaccine	Placebo comparator	Received two doses of IVACFLU-S vaccine intramuscularly in children aged 6 months to under 9 years old and one dose of IVACFLU-S vaccine in children from 9 years old to under 18 years old adult over 60 years old Receives: Biological: IVACFLU-S
Placebo	Other	Received two doses of placebo intramuscularly in children aged 6 months to under 9 years old and one dose placebo in children from 9 years old to under 18 years old adult over 60 years old Receives: Biological: IVACFLU-S

What is being measured

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

Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Solicited local and systemic AEs were assessed by study staff 30 minutes after vaccination.
Measured: Within 30 minutes of vaccination
Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Solicited local AEs were assessed by study staff 30 minutes after vaccination then daily for 7 days
Measured: within 7 days (day 1 to 7) of each vaccination
Number of Subjects Experiencing Unsolicited Adverse Events (AE)
Unsolicited AEs were observed by study staff while the subject is at a clinic for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination was to be recorded as an unsolicited AE
Measured: within 21 days (age group 9-17 and older than 60 years) or 49 days (group 6 months to 8 years) after each vaccination
Number of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
A serious adverse event (SAE) is defined as an AE that meets one of the following conditions:
- Deadly.
- Life-threatening.
- Requires inpatient hospital admission or extended stay in hospital.
- Causes birth defects.
- Causes permanent or permanent injury or disability.
- Critical medical events that may not be fatal, not life-threatening, or require inpatient treatment will be considered a SAE if it is judged by professional judgment that the incident would be potentially dangerous. subject's health and the need for medical or surgical intervention to prevent one of the aforementioned consequences
Measured: Day 1 to Day 91
Number of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine
Measured: Day 22 (+7) for groups 9 years and above or 49 (+7) for groups of 6 months to under 9 years

Secondary outcomes (3)

Number of Subjects With Hemagglutination Inhibition (HAI) Antibody tiers ≥ 1:40 for each antigenic component of the vaccine
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine
Measured: Day 22 or 49 after vaccination ( depending on age group)
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22 or 49 after vaccination (depending on age group) for each antigenic component of the vaccine
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine
Measured: Day 0, Day 22 and Day 49
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine
Measured: Day 0, Day 22 and Day 49

Timeline

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

5 Sep 20201 Apr 2022

First posted5 Jan 2021
Study start5 Sep 2020
Primary completion20 Dec 2020
Study completion1 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for InfluenzaStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 864 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04695717
Sponsor's protocol ID: VX.2020.01
Status last verified: Jun 2023
First submitted: 28 Dec 2020
Last updated: 3 Jul 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Extensive, Double-blind, Randomized, Placebo-controlled Phase 3 Study to Evaluate the Safety and Immunogenicity of the Seasonal Inactivated, Split Virion, Trivalent Influenza Vaccine (IVACFLU-S) Produced in Children and the Elderly in Vietnam
ClinicalTrials.gov ID: NCT04695717
Acronym / sponsor ID: VX.2020.01
Conditions: Influenza
Keywords: Influenza; vaccine; Seasonal influenza vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 864 participants (actual)
Lead sponsor: Vietnam Military Medical UniversityUniversity, hospital or other
Collaborators: Institute of Vaccines and Medical Biologicals, Vietnam, Vietstar Biomedical Research
Study start: 5 Sep 2020 (actual)
Primary completion: 20 Dec 2020 (actual)
Study completion: 1 Apr 2022 (actual)
First posted: 5 Jan 2021 (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.

The main target:

Evaluating the safety of the single or double dose of seasonal influenza vaccine (IVACFLU-S) in Vietnamese children aged 6 months to 17 years and adults over 60 years old.

Detailed description

Influenza A / H1N1 strain: Recombinant strain IVR-190 44250 E12 of the strain (A / Brisbane / 02/2018).

Influenza strain A / H3N2: strain IVR-197 (H3N2) 44850 E14 recombinant strain (A / South Australia / 34/2019).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Vaccine	Placebo comparator	Biological: IVACFLU-SReceived two doses of IVACFLU-S vaccine intramuscularly in children aged 6 months to under 9 years old and one dose of IVACFLU-S vaccine in children from 9 years old to under 18 years old adult over 60 years old
Placebo	Other	Biological: IVACFLU-SReceived two doses of placebo intramuscularly in children aged 6 months to under 9 years old and one dose placebo in children from 9 years old to under 18 years old adult over 60 years old

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (15 listed)

Must have a sponsor (Father / Mother / Legal relative) and get the consent of the sponsor by signing a consent form to participate in the study. (Groups from 6 months to 8 years old must have a direct sponsor, groups 9-17 years old must have an indirect sponsor).
The sponsor must be able to read and write and must commit to taking the child or asking the child to visit on schedule.
If the Sponsor is not the child's parent, he/she must get the consent of the child's father/mother in writing.
Healthy or previous acute illness but stabilized within 2 weeks before injection.
No chronic disease (cancer, heart failure, kidney, liver ...) or chronic disease that has stabilized 3 months before injection.

Key exclusion criteria (16 listed)

Currently (within 2 weeks from the time of selection) with severe acute illness with or without fever.
Participation in another therapy-related clinical trial within the past 3 months or plan to participate in a similar clinical trial at the same time it is.
Use any other vaccine for 4 weeks prior to joining or refusing to delay vaccination of such vaccines until after the visit on Day 22 (for groups ≥ 9 years) or day 49 (with groups <9 years old).
Having been vaccinated against influenza in the past 11 months (only children 6 months to 8 years old who have been previously vaccinated with influenza vaccine (from birth) are also exclusion criteria).
Use immunoglobulins or other hematological products within 3 months prior to study enrollment or plan to use these products prior to day 22 visit (for groups ≥ 9 years) or day 49 (with groups <9 years old).

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
IVACFLU-SThe Seasonal Inactivated, Split Virion, Trivalent Influenza Vaccine (TIV) were purified by the method of super centrifugation to create gradient segments in sucrose sugar produced by IVAC, or placebo produced by IVAC. Vaccines are produced on eggs, inactivated with formaldehyde. The dose of the vaccine tested was 15 mcg of HA for each antigen component in 0.5 ml. The influenza virus strains used to produce the 2020-2021 seasonal vaccine will also be provided by the NIBSC, which will be used according to WHO's recommendation, which is expected to include the following Southern Hemisphere strains: Influenza A / H1N1 strain: Recombinant strain IVR-190 44250 E12 of the strain (A / Brisbane / 02/2018). Influenza strain A / H3N2: strain IVR-197 (H3N2) 44850 E14 recombinant strain (A / South Australia / 34/2019). Flu strain B (B / Washington / February 2019).	Biological	Placebo, Vaccine

Primary outcome

Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Time frame: Within 30 minutes of vaccination
Solicited local and systemic AEs were assessed by study staff 30 minutes after vaccination.
Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Time frame: within 7 days (day 1 to 7) of each vaccination
Solicited local AEs were assessed by study staff 30 minutes after vaccination then daily for 7 days
Number of Subjects Experiencing Unsolicited Adverse Events (AE)
Time frame: within 21 days (age group 9-17 and older than 60 years) or 49 days (group 6 months to 8 years) after each vaccination
Unsolicited AEs were observed by study staff while the subject is at a clinic for a study visit or reported by the subject at any time. Any sign or symptom that would normally be considered a "solicited AE" (for example, fever, nausea, injection site pain) starting after 7 days post-vaccination was to be recorded as an unsolicited AE
Number of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
Time frame: Day 1 to Day 91
A serious adverse event (SAE) is defined as an AE that meets one of the following conditions: * Deadly. * Life-threatening. * Requires inpatient hospital admission or extended stay in hospital. * Causes birth defects. * Causes permanent or permanent injury or disability. * Critical medical events that may not be fatal, not life-threatening, or require inpatient treatment will be considered a SAE if it is judged by professional judgment that the incident would be potentially dangerous. subject's health and the need for medical or surgical intervention to prevent one of the aforementioned consequences
Number of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Time frame: Day 22 (+7) for groups 9 years and above or 49 (+7) for groups of 6 months to under 9 years
Serum specimens during Phase 3 were tested for the presence and titer of HAI antibodies to each one of the influenza strains represented in the vaccine

3 secondary outcomes

Number of Subjects With Hemagglutination Inhibition (HAI) Antibody tiers ≥ 1:40 for each antigenic component of the vaccine
Time frame: Day 22 or 49 after vaccination ( depending on age group)
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22 or 49 after vaccination (depending on age group) for each antigenic component of the vaccine
Time frame: Day 0, Day 22 and Day 49
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
Time frame: Day 0, Day 22 and Day 49

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 3 Jul 2023.
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.

Pham N Hung, Prof. principal investigator

Vietnam Military Medical University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IVACFLU-S in people with Influenza, run by Vietnam Military Medical University at 2 sites 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 15 inclusion and 16 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 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?

Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE) (time frame: Within 30 minutes of vaccination). The study lists 5 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 NCT04695717.

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 3 Jul 2023.