A Phase 3 interventional study of Inactivated SARS-CoV-2 Vaccine (Vero cell) and Inactivated SARS-CoV-2 Vaccine (Vero cell) in COVID-19, sponsored by China National Biotec Group Company Limited. Completed at 6 sites in 4 countries. Open to participants aged 18 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 3, Interventional, and Prevention
This is a multicenter, randomized, double blind, parallel placebo controlled, phase 3 clinical trial to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the protective efficacy, safety and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above. The participants were randomized into three groups of investigational vaccine 1, investigational vaccine 2 and placebo in a 1:1:1 ratio.2 doses of the investigational vaccine or placebo are inoculated into the deltoid muscle of the either arm according to the vaccination schedule of D0 \& D21 (+7 days).According to the immune durability results in Phase I/II study, and cross-neutralization assay results, a third dose (booster dose) generates a better immune response and is estimated to offer better protection, therefore, a booster dose will be given after 3 months
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 44,101 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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP according to the immunization schedule of D0 \& D21.
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP according to the immunization schedule of D0 \& D21.
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
Participants will receive 2 doses of Placebo according to the immunization schedule of D0 \& D21.
Biological: Placebo
Participants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by WIBP after 3 months following two doses of immunization.
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
Participants will receive a booster dose of the inactivated SARS-CoV-2 vaccine (Vero cell) manufactured by BIBP after 3 months following two doses of immunization.
Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)
Participants will receive a booster dose of Placebo after 3 months following two doses of immunization.
Biological: Placebo
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
The incidence of COVID-19 cases after two-doses of vaccination
Time frame: From14 days after the second dose to 6 month after the second dose
The incidence of COVID-19 cases after the booster dose of immunization
Time frame: From 14 days after the booster dose
The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination
Time frame: From 14 day after the second dose to 6 month after the second dose
The incidence of severe cases of COVID-19 and deaths accompanied by COVID-19 after two-doses of vaccination
Time frame: From 14 day after the booster dose
The incidence of any adverse reactions/events
Time frame: 28 days after each immunization
The incidence of serious adverse events (SAE)
Time frame: From the beginning of the first dose to 12 months after the second immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after full course of immunization
The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after full course of immunization
The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days after full course of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 28 days, 3rd month, 6th month, 9th month, and 12th month after 2 doses of immunization
The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days, 28 days and 6th month after the booster dose
The 4-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days, 28 days and 6th month after the booster dose
The Geometric Mean Fold Rise (GMFR) of anti-SARS-CoV-2 neutralizing antibody
Time frame: 14 days, 28 days and 6th month after the booster dose
the anti-SARS-CoV-2 neutralizing antibody protective level against COVID-19
Time frame: 14 days after 2 doses of vaccination
The occurrence of ADE
Time frame: From the beginning of the first dose to 12 months after the second immunization
Plan to share: No
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Inactivated SARS-CoV-2 Vaccine
China National Biotec Group Company Limited →