A Phase 4 interventional study of 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated and 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated in Covid19, sponsored by China National Biotec Group Company Limited. Active, not recruiting at 1 site in China. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-18.
Sponsored by China National Biotec Group Company Limited (part of Sinopharm) · Phase 4, Interventional, and Prevention
This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules compared to that in population aged 18-59 years old with 2-dose schedule. And subjects in the same age are randomly assigned to different immunization schedule groups.
This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules (D0,21,42, D0, 21,111,or D0,21,171)compared to that in population aged 18-59 years old with 2-dose schedule (D0,21). And subjects in the same age are randomly assigned to different immunization schedule groups.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 4,400 is above the median of 102 across 4,364 interventional studies indexed under COVID-19.
Browse COVID-19 studies →China National Biotec Group Company Limited is the lead sponsor of 37 studies on the registry; 2 are open to participants now.
First submitted after China National Biotec Group Company Limited became part of Sinopharm.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
300 subjects age ≥ 71 （A1）receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
200 subjects age ≥ 71 （A2）receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
200 subjects age ≥ 71 (A3) receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
300 subjects age 60-70 (B1) receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
200 subjects age 60-70 (B2) receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
200 subjects age 60-70 (B3) receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
300 subjects age 18-59 (C1) receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
200 subjects age 18-59 (C2) receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
200 subjects age 18-59 (C3) receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
300 subjects age 18-59 (C4) receive 2 doses of vaccine
Biological: 2 doses of vaccine
300 subjects age 9-17 (D1) receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
200 subjects age 9-17 (D2) receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
200 subjects age 9-17 （D3）receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
300 subjects age 9-17 （D4）receive 2 doses of vaccine
Biological: 2 doses of vaccine
300 subjects age 3-8 （E1） receive 3 doses of vaccine
Biological: 3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated
200 subjects age 3-8 （E2）receive 3 doses of vaccine
Biological: 3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated
200 subjects age 3-8 （E3）receive 3 doses of vaccine
Biological: 3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated
300 subjects age 3-8 （E4）receive 2 doses of vaccine
Biological: 2 doses of vaccine
the schedule of Day 0, 21, 42
the schedule of Day 0, 21, 111
the schedule of Day 0, 21, 171
the schedule of Day 0, 21
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: 14 days after the full course immunization
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Time frame: 14 days after the full course immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: 14 days after the second dose in schedule of Day 0,21,42
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Time frame: 14 days after the second dose in schedule of Day 0,21,42
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
≥4 fold increase from baseline
Time frame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
Immune Persistence
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: 3 months, 6 months, 12 months after the full course immunization
Safety index-Incidence of adverse reactions
collect the all the adverse events using dairy card and contact card
Time frame: From the beginning of the vaccination to 28 days after the full course immunization
Safety index-Incidence of serious adverse events
All SAEs will be collected
Time frame: From the beginning of the vaccination to 6 months after the full course immunization
Immune Persistence
Neutralizing antibody assay will be performed using the Microcytopathic assay
Time frame: 18 months and 24 months after the full immunization
Ran from Apr 2021 to primary completion in Dec 2021, 7 months.
Of 43 industry-sponsored phase 4 interventional studies under COVID-19, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 11. This study's 7 months is above that.
Counting every sponsor, half of 188 studies reached it within 8 months; a quarter within 4 and three quarters within 16.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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