This study is a pediatric dose-ranging study to evaluate the safety and immunogenicity of vaccination with different MF59-adjuvanted H5N1 vaccine formulations.
Who can participate
Age range
6 Months – 8 Years
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
. Healthy male and female subjects of 6 months through \<9 years of age on the day of informed consent/assent.
. Documented consent provided by the subject's parent(s)/LAR(s) have voluntarily given written informed consent/assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
. Subject's parent(s)/LAR(s) able to comprehend and comply with all study procedures, and available for all clinic visits and telephone contacts scheduled in the study.
. Subjects must provide a baseline blood sample within 10 days prior to the Day 1 vaccination.
Exclusion criteria
. Progressive, unstable or uncontrolled clinical conditions.
. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws, ie,
. Subjects who have had a fever (body temperature measurement ≥ 38°C) within three days prior to vaccination. The subject may return for vaccination after they have been free of fever for three days.
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
Safety Endpoint 1: Percentages of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Timeframe: Day 1 through Day 7 and Day 22 through Day 28
2
Safety Endpoint 2: Percentages of Subjects With Any Unsolicited AEs
Timeframe: Day 1 through Day 43
3
Safety Endpoint 3: Percentages of Subjects Reporting Serious Adverse Events (SAEs), New-onset Chronic Disease (NOCD), Adverse Events of Special Interest (AESI), and AEs Leading to Vaccine and/or Study Withdrawal
Timeframe: Day 1 through Day 387
4
Primary Immunogenicity Endpoint 1a: Geometric Mean Titers (GMTs), as Measured by Hemagglutination Inhibition (HI) and Microneutralization (MN) Assays Against the Homologous H5N1 Strain
Timeframe: Day 1 (baseline), Day 22, and Day 43
5
Primary Immunogenicity Endpoint 1b: Geometric Mean Ratios (GMR), as Measured by HI and MN Assays Against the Homologous H5N1 Strain
Timeframe: Day 1 (baseline), Day 22, and Day 43
6
Primary Immunogenicity Endpoint 1c: Percentage of Subjects Achieving Seroconversion (Non-detectable to ≥1:40, or 4-fold Increase From a Detectable Day 1 Titer)
. History of epilepsy or convulsions (excluding febrile convulsions).
. A subject who has any medical condition meeting the definition of AESI defined for the purposes of this trial (see appendix A).
. Subjects who have received antipyretic medication within the past 24 hours prior to vaccination. The subject may return for vaccination after a period of 24 hours has passed since the administration of an antipyretic.
. Abnormal function of the immune system resulting from:
Timeframe: Day 1 (baseline), Day 22, and Day 43
7
Primary Immunogenicity Endpoint 1d: Percentage of Subjects Achieving Seroconversion With a Titer ≥1:40