A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Var… (NCT05652543) | Clinical Trial Compass
CompletedPhase 2
A PhaseⅡ Study to Evaluate the Safety & Immunogenicity of SARS-CoV-2 Alpha/Beta/Delta/Omicron Variants COVID-19 Vaccine
China518 participantsStarted 2023-01-05
Plain-language summary
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the safety and immunogenicity of SCTV01E in population of different ages who have been vaccinated against COVID-19. A total of 750 participants ≥3 years old who have received the recommended dose and immunization procedure of domestically approved COVID-19 vaccines will be enrolled, including 250 participants ≥18 years old (group A), 250 participants aged 12-17 years old (group B), and 250 participants aged 3-11 years old (group C). The study will be carried out gradually according to the age of the participants from older to younger. Considering that SCTV01E in this study is the first clinical study in participants under 18 years old, 15 sentinel participants will be assigned to group B and 30 sentinel participants will be assigned to group C (including 15 aged 6-11 years old and 15 aged 3-5 years old).
The Primary end points are 1. The incidence and severity of solicited adverse events on days 0-7 after inoculation with SCTV01E. 2. IgG total antibody concentrations (ELISA) against SARS-CoV-2 prototype strains and neutralizing antibodies titer (Live virus neutraliztion antibody test) against SARS-CoV-2 Omicron variant at 28 days post-vaccination.
Who can participate
Age range
3 Years – 120 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:
* The age when signing ICF should meet the requirements of the scheme (Group A ≥18 years old; Group B 12-17 years old; Group C, 3-11 years old) male or female;
* Have previously received the recommended dose and immunization procedures of COVID-19 vaccine approved for domestic market, and the interval between signing ICF and receiving the last dose of COVID-19 vaccine is 6-24 months;
* Subject and/or guardian or client of both parties are able to sign a written ICF and voluntarily participate in the trial, fully understand the trial procedure, the risks of participating in the trial and the alternative interventions available to non-participants;
* The subject and/or the guardian or client of both parties can read, understand and fill in the diary card;
* Healthy subjects or subjects with stable underlying diseases. Stable underlying diseases were defined as those who were in stable condition at least 3 months before inclusion in the study, had no significant change in treatment regimen and had not been admitted to hospital due to disease progression;
* Fertile men and women of childbearing age voluntarily agree to take effective contraceptive measures from signing the ICF to 180 days after receiving the trial vaccine; Pregnancy tests for women of childbearing age during the screening period were negative.
Exclusion Criteria:
* Fever (\> 14 years of age, axillary temperature ≥37.3℃; ≤14 years old, axillary temperature ≥37.5℃);
* SARS-CoV-2 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
Safety endpoint: Incidence and severity of Solicited Adverse Events
Timeframe: Day 0~Day 7
2
Immunogenicity endpoint 1: IgG total antibody concentration (ELISA)