|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT03095599 |
|
Date of registration:
|
13/03/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) - PHASE 2/3
IVACFLUS-0203 |
|
Scientific title:
|
A Phase 2/3 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 |
|
Date of first enrolment:
|
March 20, 2017 |
|
Target sample size:
|
889 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03095599 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
Vietnam
| | | | | | | |
|
Contacts
|
|
Name:
|
Phan Cong Hung, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pasteur Institute, Ho Chi Minh City |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
- Aged 18 through 60 years on the day of screening/enrollment.
- Literate (by self-report) and willing to provide written informed consent.
- Able to attend all scheduled visits and to comply with all study procedures.
- Healthy or medically stable, as established by medical history and physical
examination. For individuals with medical conditions, symptoms/signs, if present must
be stable under controlled or unchanged for the past 3 months. If medication is used
to treat the condition, the medication dose must have been stable for at least 1 month
preceding vaccination.
For female subjects:
- Not breastfeeding or pregnant (based on negative urine pregnancy test) or plan to
become pregnant up to Day 22. Women who are not surgically sterile (hysterectomy or
tubal ligation) or post-menopausal for more than 1 year must have negative pregnancy
test and, be willing to utilize reliable birth control measures (intrauterine device,
hormonal contraception, condom or diaphragm with spermicide) through the Day 22 visit.
Exclusion criteria:
- Current or recent (within 2 weeks of enrollment) acute severe illness with or without
fever.
- Participation in another clinical study involving any therapy within the previous 3
months or planned enrollment in such a study 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.
- Received seasonal influenza vaccine in last 6 months
- 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.
- Known or suspected congenital or acquired immunodeficiency.
- Chronic administration (defined as more than 14 consecutively-prescribed days) of
immunosuppressants or other immune-modulating therapy within 6 months prior to study
enrollment. (For corticosteroids, this means prednisone or equivalent, = 0.5
mg/kg/day; topical steroids are allowed).
- Unstable illness by history or physical examination that in the opinion of the
Investigator, might interfere with the conduct or results of the study or pose
additional risk to the subject.
- Hypersensitivity after previous administration of any vaccine.
- Suspected or known hypersensitivity to any of the study vaccine components, including
chicken or egg protein, and rubber (from the vaccine vial stoppers).
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion.
- Known active tuberculosis or symptoms of active tuberculosis, regardless of cause
(self-report).
- Current alcohol or drug addiction that in the opinion of the Investigator, might
interfere with the ability to comply with study procedures.
- History of Guillain-Barré Syndrome
- Neoplastic disease or any hematologic malignancy.
- 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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Influenza, Human
|
|
Intervention(s)
|
|
Biological: IVACFLU-S
|
|
Other: Placebo
|
|
Primary Outcome(s)
|
|
Number and Percentage of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
[Time Frame: Day 1 to Day 91]
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22, Overall and by Age Group
[Time Frame: Day 1, Day 22]
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE)
[Time Frame: Within 30 minutes of vaccination]
|
|
Number and Percentage of Subjects Experiencing Fever
[Time Frame: Day 1 to Day 7]
|
|
Number and Percentage of Subjects Experiencing Solicited Local Adverse Events (AE), by Severity
[Time Frame: Day 1 to Day 7]
|
|
Number and Percentage of Subjects Experiencing Unsolicited Adverse Events (AE)
[Time Frame: Day 1 to Day 21]
|
|
Number and Percentage of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
[Time Frame: Day 1, Day 22]
|
|
Geometric Mean Fold Change of Serum Hemagglutination Inhibition (HAI) Antibody Titer, Overall and by Age Group
[Time Frame: Day 1, Day 22]
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE)
[Time Frame: Within 30 minutes of vaccination]
|
|
Number and Percentage of Subjects Experiencing Solicited Systemic Adverse Events (AE), by Severity
[Time Frame: Day 1 to Day 7]
|
|
Secondary Outcome(s)
|
|
Number and Percentage of Subjects With at Least a 4-fold Increase in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
[Time Frame: Day 22]
|
|
Geometric Mean Fold Change in HAI Antibody Titer, by Strain, Age Group, and Baseline Titer
[Time Frame: Day 1, Day 22]
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 18-45
[Time Frame: Day 1, Day 22]
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: All Subjects
[Time Frame: Day 1, Day 22]
|
|
Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens at Baseline and Day 22: Subjects Aged 46-60
[Time Frame: Day 1, Day 22]
|
|
Secondary ID(s)
|
|
CVIA 051
|
|
IVACFLU-S 0203
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|