The Thai MOPH recommends seasonal influenza vaccines to eight high- risk groups, As healthy adults aged 18-64 are not at increased risk of influenza infection and severity. Phase3 RCT, Trivalent Inactivated Influenza Vaccine, Healthy adult
Conditions
Interventions
Saline placebo solution, 0.5 mL will be administered intramuscularly (IM) in the deltoid muscle.,(seasonal trivalent inactivated split virion influenza vaccine recommended for Southern hemisphere in 2
A/Switzerland/8060/2017 (H3N2)-like virus
and a B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage)]
0.5 mL will be administered intramuscularly (IM) in the deltoid muscle.
,Each dose of Tri Fluvac contains a total of 45 micrograms hema
and a B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage)]
The vaccine will be administered as a single 0.5ml intramuscular injection, preferably in the region of the deltoid muscle of the upper
Placebo Comparator No treatment,Active Comparator Biological/Vaccine,Experimental Biological/Vaccine
Saline placebo solution, 0.5 mL ,An established influenza vaccine licensed in Thailand ,Tri Fluvac is a seasonal trivalent inactivated split virion influenza vaccine recommended for So
Sponsors
The Goverment Pharmaceutical Organization
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Age 18-64 years old on the day of vaccination, having Thai ID card or equivalent Able to read and write in Thai and sign written informed consent form Able to attend all scheduled visits and to comply with all trial procedures. Healthy or medically stable, as established by medical history and physical examination. For female participants of reproductive age (18-49 years): Not breast feeding, non-pregnant (based on negative urine pregnancy test) and no plan to become pregnant during the study period Women who are post-menopausal (until 49 years of age) or not surgically sterile (hysterectomy or tubal ligation) must be willing to use effective contraceptive method to prevent pregnancy after vaccination. Effective methods include intrauterine device, hormonal contraceptives (oral, injectable, patch, implant, ring) or double barrier contraceptives (condom or diaphragm with spermicide). Women with credible history of abstinence may be enrolled at the discretion of the investigator
Exclusion criteria
Exclusion criteria: Participation in another clinical trial involving any therapy within the previous three months or planned enrolment in such a trial during the period of this study. Hypersensitivity after previous administration of any vaccine. Having a history of lab-confirmed influenza infection within 3 months preceding enrolment to the trial Vaccination against influenza in the past 12 months preceding enrolment to the trial (reviewed by vaccination record at NHSO and oral history) Receipt of any non-study vaccine within four weeks prior to enrolment or refusal to postpone receipt of such vaccines until after the Day 28 visit. Having a health condition placing the potential participant in a risk group recommended for routine influenza vaccination by Advisory Committee on Immunization Practices (ACIP), e.g. chronic pulmonary (including asthma), cardiovascular, renal, hepatic, hematological, or metabolic disorders (including diabetes mellitus); immunosuppressive illness, recent/ongoing receipt of immunosuppressive therapy, or human immunodeficiency virus infection Individuals employed in professions prone to influenza transmission to or from high-risk populations are not eligible to participate e.g. Healthcare workers and poultry cullers (also based on ACIP recommendations) History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. eggs, gentamicin, or thimerosal) History of Guillain-Barr Syndrome. Having acute infection with fever > 38 degree Celsius and noninfectious diseases (within 72 hours) preceding enrolment in the trial The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past 3 months before the beginning of the trial or planned receipt of such products prior to the Day 28 visit. Current alcohol abuse or drug addiction (high risk level - based on criteria of Department of Mental Health: score of 13 or more) that might interfere with the ability to comply with trial procedures Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled, or could interfere with the evaluation of the vaccine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titers (GMTs) of serum HI antibodies pre- (Day 0) and post-vaccination (Day 28) Day 0,28, 180. 360 Blood collection for HI antibody titer three strains of influenza virus,Seroprotection and seroconversion of post-vaccination (Day 28 ,180, 360) Day 0,28, 180. 360 Blood collection for HI antibody titer three strains of influenza virus,RT-PCR-confirmed influenza cases in all participants Weekly from Day 15 up to 12 months after the vaccination NP swab for influenza subtype in case of ARI/ILI and SARI,safety endpoint During the 7 day post vaccination count and percentage of solicited local and systemic reactions | — |
Secondary
| Measure | Time frame |
|---|---|
| ILI/SARI During the study period Clinical criteria,Number and percentage of participant with HI titer >= 1:40 / GMFRs Day 28 post vaccination Blood collection for HI antibody titer three strains of influenza virus,GMT of serum HI titer Day 0, 28, 180, 360 Blood collection for HI antibody titer three strains of influenza virus | — |
Countries
Thailand
Contacts
Public ContactKriengkrai Prasert
Nakhon Phanom Hospital
Outcome results
None listed