Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021… (NCT04551677) | Clinical Trial Compass
CompletedPhase 4
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
United States90 participantsStarted 2020-09-16
Plain-language summary
Primary Objective:
To provide serum samples (collected from participants before vaccination \[Blood Sample 1\] and after final vaccination \[Blood Sample 2\]) to Center for Biologics Evaluation and Research (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines. In addition, serum samples from adult participants may be further analyzed by the Sponsor to assess breadth of immune response induced by the study vaccines.
Who can participate
Age range
6 Months – 84 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 :
* Aged 6 months to \<9 years or \>=65 years of age on the day of first study vaccination (study product administration).
* 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 kilograms \[kg\]).
* Informed consent form (ICF) was signed and dated by participants \>=65 years of age.
* Assent form was signed and dated by participants 7 to \<9 years of age, and ICF was signed and dated by parent(s) or guardian(s) for participants 6 months to \< 9years of age.
* Participants and parent/guardian (of participants 6 months to \<9 years of age) were able to attend all scheduled visits and to comply with all study procedures.
Exclusion criteria:
\- Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
Note: Participants were considered eligible for enrollment if no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the participant would complete safety surveillance for the present study.
* Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 2 for participants received 1 dose of influenza vaccine or Visit 3 for participants received 2 dos…
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/Visit 3
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)