A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Bo… (NCT05933512) | Clinical Trial Compass
UnknownPhase 2
A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines
600 participantsStarted 2023-08-10
Plain-language summary
This study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with recommended doses and immunization schedules are planned to be enrolled. Group A included 400 patients aged 18 years and above, and group B included 200 patients aged 3-17 years.
Who can participate
Age range
3 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:
* 1\. Aged ≥3 years old when signing ICF;
* 2\. Participants who were vaccinated with licenced COVID-19 vaccines with recommended doses and immune schedule, and the interval between the last dose and ICF is ≥6 months.
* 3\. The participant and/or his/her legal guardians or entrusted person can sign the written ICF, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that can be selected if they do not participate in the trial;
* 4\. The participant and/or his/her legal guardians or entrusted person have the ability to read, understand, and fill in record cards;
* 5\. Healthy participants or participants with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or no need for hospitalization as a consequence of worsening disease state for at least 3 months prior to enrollment;
* 6\. Fertile men and women of childbearing potential voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.
Exclusion Criteria:
* 1\. Presence of fever within 72 hours before the study vaccination (for participants \>14 years old, axillary temperature ≥37.3℃; for participants ≤14 years old, axillary temperature ≥37.5℃;);
* 2\. A positive result of antigen test or nucleic acid …
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
Geometric mean titers (GMT) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.
Timeframe: day 14 after the study vaccination
2
Seroresponse Rate (SRR) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.