Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022… (NCT05050318) | Clinical Trial Compass
CompletedPhase 4
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
United States90 participantsStarted 2021-09-08
Plain-language summary
This was a phase IV, multi-center, open-label study. The study collected serum samples from children 6 months to less than (\<) 9 years of age who received Fluzone Quadrivalent vaccine and adults greater than or equal to (\>=) 65 years of age who received Fluzone High-Dose Quadrivalent vaccine for submission to CBER to aid in the influenza vaccine strain selection process.
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:
* Aged 6 months to \< 9 years or \>= 65 years of age on the day of first study vaccination (study product administration).
* For infants and toddlers, born at full term of pregnancy (\>=37 weeks) or born after a gestation period of 27 through 36 weeks.
* For participants 6 to \< 12 months of age, born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 5.5 pound (lbs) (2.5 kilogram \[kg\]).
* Informed consent form (ICF) has been signed and dated by participants \>= 65 years of age.
* Assent form has been signed and dated by participants 7 to \< 9 years of age, and ICF has been signed and dated by parent(s) or another legally acceptable representative for participants 6 months to \< 9 years of age.
* Participants or participant and parent/legally acceptable representative (of participants 6 months to \< 9 years of age) were able to attend all scheduled visits and complied with all study procedures.
Exclusion Criteria:
* Participants are excluded from the study if any of the following criteria apply:
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the 3 months preceding planned inclusion).
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-th…
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 Participants Aged 6 Months to <9 Years Who Provided Serum Samples for Analysis: Groups 1 and 2
Timeframe: Visit 1 (Day 1; pre-vaccination) and 28 days post-final vaccination at Visit 2 (for participants with 1 vaccination)/Visit 3 (for participants with 2 vaccination)
2
Number of Participants Aged >=65 Years Who Provided Serum Samples for Analysis: Group 3
Timeframe: Visit 1 (Day 1; pre-vaccination) and 21 days post-vaccination (Visit 2)