- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598089
Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) (IVACFLU-S)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Thai Binh Province
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Thai Binh, Thai Binh Province, Vietnam
- Hung Ha District Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Trivalent Seasonal Influenza Vaccine
0.5 mL of seasonal trivalent influenza vaccine with 15 mcg of HA of each of 3 strains:
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Other Names:
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Placebo Comparator: Placebo
This is the placebo comparator: 0.5 mL of Phosphate Buffered Saline
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0.5 mL of phosphate buffered saline
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Immediate Adverse Events
Time Frame: 30-minute post-vaccination period.
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Any adverse event occurring within the 30 minute post vaccination period.
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30-minute post-vaccination period.
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Number and Percentage of Participants Reporting Solicited Local Reactogenicity
Time Frame: 7-day period (Days 1-7) post-vaccination.
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Number of subjects reporting solicited local reactions (redness, swelling, pain, hardness, and tenderness) at the injection site post-vaccination with study vaccine or placebo.
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7-day period (Days 1-7) post-vaccination.
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Number and Percentage of Participants Reporting Solicited Systemic Reactogenicity
Time Frame: 7-day period (Days 1-7) post-vaccination
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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
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7-day period (Days 1-7) post-vaccination
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Number and Percentage of Participants With Unsolicited Adverse Events
Time Frame: Within 21 days post-vaccination
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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. |
Within 21 days post-vaccination
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Number and Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: Over the entire study period (Day 91)
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Over the entire study period (Day 91)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and Percentage of Subjects With Seroconversion Against Each of the 3 Antigens
Time Frame: Day 22
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Seroconversion is defined as a serum HAI titer meeting the following criteria:
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Day 22
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Number and Percentage of Seroprotected Subjects Against 3 Strains of Influenza Vaccine
Time Frame: Day 1 and Day 22 post vaccination
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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.
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Day 1 and Day 22 post vaccination
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Geometric Mean Titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) Antibodies for Each Antigen
Time Frame: Pre- (Day 1) and post-vaccination (Day 22)
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Geometric mean titers (GMTs) of Serum Hemaggluntination Inhibition (HAI) antibodies pre- (Day 1) and post-vaccination (Day 22) for each of the 3 antigens.
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Pre- (Day 1) and post-vaccination (Day 22)
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Geometric Mean Fold Rises (GMFRs) of Serum Hemaggluntination Inhibition (HAI) Antibodies
Time Frame: Day 22/Day1
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Geometric mean fold rises (GMFRs) of serum hemaggluntination inhibition (HAI) antibodies post-vaccination/pre-vaccination for each of the 3 antigens
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Day 22/Day1
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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)
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Pre- (Day 1) and Post-vaccination (Day 22)
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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)
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Pre- (Day 1) and Post-vaccination (Day 22)
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dang D. Anh, Ph. D, National Institute of Hygiene and Epidemiology, Vietnam
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IVACFLU-S-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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