Influenza, HumanPhase 1IVACFLU-SNCT02598089
Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S)
A Phase 1 study testing Trivalent Seasonal Influenza Vaccine in people with Influenza, Human, run by Institute of Vaccines and Medical Biologicals, Vietnam at 1 site in Vietnam.
Trial summary
This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains) or placebo (phosphate buffered saline). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Trivalent Seasonal Influenza Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- Nov 2015to Feb 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female adult 18 through 45 years of age at the enrollment visit.
- Literate (by self-report) and willing to provide written informed consent.
- Healthy, as established by the medical history, physical examination, and screening laboratory evaluations.
- Capable and willing to complete Diary Cards and willing to return for all follow-up visits.
- For females, willing to utilize reliable birth control measures (e.g., intrauterine device, hormonal contraception, condoms) through the Day 22 visit.
Who cannot join
- Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
- Receipt of any non-study vaccine within 4 weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 22 visit.
- Current or recent (within 2 weeks of enrollment) acute illness with or without fever.
- Receipt of immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 22 visit.
- Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, 0.5 mg per kg per day; topical steroids are allowed.)
- History of asthma.
Show all 21Show fewer
- Hypersensitivity after previous administration of any vaccine.
- Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein, antibiotics, and rubber (from the vaccine vial stoppers).
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatobiliary, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
- History of any blood or solid organ cancer.
- History of thrombocytopenic purpura or known bleeding disorder.
- History of seizures.
- Known or suspected immunosuppressed or immunodeficient condition of any kind.
- Confirmed hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Known human immunodeficiency virus (HIV) infection (self-report).
- Known active tuberculosis or symptoms of active tuberculosis, regardless of cause (self-report).
- History of chronic alcohol abuse and/or illegal drug use.
- Pregnancy or lactation. (A negative pregnancy test will be required before administration of study product for all women of childbearing potential.)
- History of Guillain-Barré Syndrome
- Any condition that, in the opinion of the investigator, would increase the health risk to the subject if he/she participates in the study or would interfere with the evaluation of the study objectives.
- Note: Minor out-of-range laboratory values no greater than Grade 1 will not be considered to be exclusionary at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study In Healthy Adult Volunteers In Vietnam To Examine The Safety And Immunogenicity Of A Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) Produced By IVAC
This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).
Read the detailed description
This is a phase 1, single center, double blinded, randomized, placebo-controlled study. Sixty (60) healthy male and female adults, 18 to 45 years of age, will be enrolled into the trial. Subjects will be randomized 1:1 to one of two treatment allocations: 30 to vaccine, 30 to placebo. The study will utilize a "randomized block design" to assure a balance of 1:1 vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning the study subjects, investigators, and the sponsor will be unaware of the treatment allocated to each subject until the clinical trial database is declared final and locked. The study should take about 5 months to complete, with each subject involved for 3 months from the day of injection. The justification for the 3 month follow up, rather than 6 month follow up is that this is an inactivated vaccine that follows very standard manufacturing practices with standard antigens. The safety of inactivated influenza vaccines is well-established. Adding length to the follow up results in delays in future testing of the vaccine for licensure.
- Conditions
- Influenza, Human
- Being tested
- Trivalent Seasonal Influenza Vaccine, Placebo
- Keywords
- Seasonal Influenza, Trivalent Vaccine, Inactivated 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.
Trivalent Seasonal Influenza VaccineBiological
Also called IVACFLU-S
PlaceboOther
0.5 mL of phosphate buffered saline
| Study group | Role | What they receive |
|---|---|---|
| Trivalent Seasonal Influenza Vaccine | Experimental | 0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains:
* NYMC BX-51B reassortant of B/Massachusetts/2/2012
* NYMC X-179A reassortant of A/California/7/2009 (H1N1)
* NYMC X-223A reassortant of H3/A/Texas/50/2012 (H3N2) Receives: Biological: Trivalent Seasonal Influenza Vaccine |
| Placebo | Placebo comparator | This is the placebo comparator: 0.5 mL of Phosphate Buffered Saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Immediate Adverse Events
Any adverse event occurring within the 30 minute post vaccination period.
Measured: 30-minute post-vaccination period.
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Number of subjects reporting solicited local reactions (redness, swelling, pain, hardness, and tenderness) at the injection site post-vaccination with study vaccine or placebo.
Measured: 7-day period (Days 1-7) post-vaccination.
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Number of subjects reporting solicted systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo
Measured: 7-day period (Days 1-7) post-vaccination
Number and Percentage of Participants With Unsolicited Adverse Events
Unsolicited AEs were any AEs that occurred any time after the vaccine/placebo was administered (temporally related to investigational product), whether or not deemed "related" to the product, and are not solicited (specifically asked of the subject). Unsolicited AEs were to be observed by the study center personnel while the subject was at the study center 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 were to be recorded as an "unsolicited AE. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher.
Note: all unsolicited AEs were mild in intensity. Please see Adverse Events section of this report for detailed information of AEs.
Measured: Within 21 days post-vaccination
Number and Percentage of Participants With Serious Adverse Events (SAEs)
Measured: Over the entire study period (Day 91)
Secondary outcomes (6)
Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens
Seroconversion is defined as a serum HAI titer meeting the following criteria:
- pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1:40 or
- pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination measured on Day 22.
Measured: Day 22
Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
A seroprotected subject was defined as a vaccinated subject who had a serum Hemagluttination Inhibition (HAI) titer >/= 1:40. The 3 influenza strains assessed were B, H1, and H3.
Measured: Day 1 and Day 22 post vaccination
Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen
Geometric mean titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) antibodies pre- (Day 1) and post-vaccination (Day 22) for each of the 3 antigens.
Measured: Pre- (Day 1) and post-vaccination (Day 22)
Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies
Geometric mean fold rises (GMFRs) of serum hemaggluntination inhibition (HAI) antibodies post-vaccination/pre-vaccination for each of the 3 antigens
Measured: Day 22/Day1
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens
Measured: Pre- (Day 1) and Post-vaccination (Day 22)
Geometric Fold Rises (GMFRs) of Neutralizing Antibodies (MNT) Post-vaccination/Pre-vaccination for Each of the 3 Antigens
Measured: Pre- (Day 1) and Post-vaccination (Day 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Vaccines and Medical Biologicals, Vietnam
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam, World Health Organization, Department of Health and Human Services, PATH, Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Dang D. Anh, Ph. D, Principal investigator, National Institute of Hygiene and Epidemiology, Vietnam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598089
- Sponsor's protocol ID
- IVACFLU-S-01
- Acronym
- IVACFLU-S
- Status last verified
- Jan 2019
- First submitted
- 15 Oct 2015
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Anh DD, Thiem VD, Anh NTH, Huong VM, Nga NT, Thang TC, Thai DH, Chien VC, Holt R, Wahid R, Flores J, Berlanda Scorza F, Taylor DN. Randomized safety and immunogenicity trial of a seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) in healthy young Vietnamese adults. Vaccine. 2016 Oct 26;34(45):5457-5462. doi: 10.1016/j.vaccine.2016.08.052. Epub 2016 Aug 24.
PubMed 27567493
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double Blinded, Randomized, Placebo-Controlled Study In Healthy Adult Volunteers In Vietnam To Examine The Safety And Immunogenicity Of A Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) Produced By IVAC
- ClinicalTrials.gov ID
- NCT02598089
- Acronym / sponsor ID
- IVACFLU-S / IVACFLU-S-01
- Conditions
- Influenza, Human
- Keywords
- Seasonal Influenza, Trivalent Vaccine, Inactivated Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Institute of Vaccines and Medical Biologicals, VietnamIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Hygiene and Epidemiology, Vietnam, World Health Organization, Department of Health and Human Services, PATH, Quintiles, Inc.
- Study start
- Nov 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 5 Nov 2015 (estimated)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).
Detailed description
This is a phase 1, single center, double blinded, randomized, placebo-controlled study. Sixty (60) healthy male and female adults, 18 to 45 years of age, will be enrolled into the trial. Subjects will be randomized 1:1 to one of two treatment allocations: 30 to vaccine, 30 to placebo. The study will utilize a "randomized block design" to assure a balance of 1:1 vaccine and placebo when all subjects are enrolled. The study will be double blinded, meaning the study subjects, investigators, and the sponsor will be unaware of the treatment allocated to each subject until the clinical trial database is declared final and locked. The study should take about 5 months to complete, with each subject involved for 3 months from the day of injection. The justification for the 3 month follow up, rather than 6 month follow up is that this is an inactivated vaccine that follows very standard manufacturing practices with standard antigens. The safety of inactivated influenza vaccines is well-established. Adding length to the follow up results in delays in future testing of the vaccine for licensure.
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 |
|---|---|---|
| Trivalent Seasonal Influenza Vaccine | Experimental | Biological: Trivalent Seasonal Influenza Vaccine0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains: * NYMC BX-51B reassortant of B/Massachusetts/2/2012 * NYMC X-179A reassortant of A/California/7/2009 (H1N1) * NYMC X-223A reassortant of H3/A/Texas/50/2012 (H3N2) |
| Placebo | Placebo comparator | Other: PlaceboThis is the placebo comparator: 0.5 mL of Phosphate Buffered Saline |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female adult 18 through 45 years of age at the enrollment visit.
- Literate (by self-report) and willing to provide written informed consent.
- Healthy, as established by the medical history, physical examination, and screening laboratory evaluations.
- Capable and willing to complete Diary Cards and willing to return for all follow-up visits.
- For females, willing to utilize reliable birth control measures (e.g., intrauterine device, hormonal contraception, condoms) through the Day 22 visit.
Key exclusion criteria (21 listed)
- Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study.
- Receipt of any non-study vaccine within 4 weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 22 visit.
- Current or recent (within 2 weeks of enrollment) acute illness with or without fever.
- Receipt of immune globulin or other blood products within 3 months prior to study enrollment or planned receipt of such products prior to the Day 22 visit.
- Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, 0.5 mg per kg per day; topical steroids are allowed.)
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 |
|---|---|---|
| Trivalent Seasonal Influenza VaccineAlso: IVACFLU-S | Biological | Trivalent Seasonal Influenza Vaccine |
| Placebo0.5 mL of phosphate buffered saline | Other | Placebo |
Primary outcome
Number of Participants With Immediate Adverse Events
Time frame: 30-minute post-vaccination period.
Any adverse event occurring within the 30 minute post vaccination period.
Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Time frame: 7-day period (Days 1-7) post-vaccination.
Number of subjects reporting solicited local reactions (redness, swelling, pain, hardness, and tenderness) at the injection site post-vaccination with study vaccine or placebo.
Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Time frame: 7-day period (Days 1-7) post-vaccination
Number of subjects reporting solicted systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo
Number and Percentage of Participants With Unsolicited Adverse Events
Time frame: Within 21 days post-vaccination
Unsolicited AEs were any AEs that occurred any time after the vaccine/placebo was administered (temporally related to investigational product), whether or not deemed "related" to the product, and are not solicited (specifically asked of the subject). Unsolicited AEs were to be observed by the study center personnel while the subject was at the study center 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 were to be recorded as an "unsolicited AE. In this study, laboratory results were considered AEs when (1) the result was judged to be clinically significant by the Principal Investigator, regardless of grade; or (2) the result is Grade 2 or higher. Note: all unsolicited AEs were mild in intensity. Please see Adverse Events section of this report for detailed information of AEs.
Number and Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Over the entire study period (Day 91)
6 secondary outcomes
Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens
Time frame: Day 22
Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
Time frame: Day 1 and Day 22 post vaccination
Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen
Time frame: Pre- (Day 1) and post-vaccination (Day 22)
Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies
Time frame: Day 22/Day1
Geometric Mean Neutralization Titers of Neutralizing Antibodies (MNT) Pre- (Day 1) and Post-Vaccination (Day 22) for Each of the 3 Antigens
Time frame: Pre- (Day 1) and Post-vaccination (Day 22)
Geometric Fold Rises (GMFRs) of Neutralizing Antibodies (MNT) Post-vaccination/Pre-vaccination for Each of the 3 Antigens
Time frame: Pre- (Day 1) and Post-vaccination (Day 22)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27567493Anh DD, Thiem VD, Anh NTH, Huong VM, Nga NT, Thang TC, Thai DH, Chien VC, Holt R, Wahid R, Flores J, Berlanda Scorza F, Taylor DN. Randomized safety and immunogenicity trial of a seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) in healthy young Vietnamese adults. Vaccine. 2016 Oct 26;34(45):5457-5462. doi: 10.1016/j.vaccine.2016.08.052. Epub 2016 Aug 24.
- Article published in the journal VaccineLink provided by the sponsor.
- 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.
Dang D. Anh, Ph. D principal investigator
National Institute of Hygiene and Epidemiology, Vietnam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trivalent Seasonal Influenza Vaccine in people with Influenza, Human, run by Institute of Vaccines and Medical Biologicals, Vietnam 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 5 inclusion and 21 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 15 Feb 2019. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Immediate Adverse Events (time frame: 30-minute post-vaccination period.). 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 NCT02598089, 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 15 Feb 2019.