This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Child… (NCT04695717) | Clinical Trial Compass
CompletedPhase 3
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
Vietnam864 participantsStarted 2020-09-05
Plain-language 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.
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.
Who can participate
Age range
6 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
\*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.
* 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 visi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Timeframe: Within 30 minutes of vaccination
2
Number of Subjects Experiencing Solicited Local and Systemic Adverse Events (AE)
Timeframe: within 7 days (day 1 to 7) of each vaccination
3
Number of Subjects Experiencing Unsolicited Adverse Events (AE)
Timeframe: within 21 days (age group 9-17 and older than 60 years) or 49 days (group 6 months to 8 years) after each vaccination
4
Number of Subjects Experiencing Unsolicited Serious Adverse Events (SAE)
Timeframe: Day 1 to Day 91
5
Number of Subjects With Seroconversion of Hemagglutination Inhibition (HAI) Antibodies for Vaccine Antigens, Overall and by Age Group
Timeframe: Day 22 (+7) for groups 9 years and above or 49 (+7) for groups of 6 months to under 9 years