A Phase 1/2 interventional study of Omicron COVID-19 Vaccine (Vero Cell), Inactivated in COVID-19, sponsored by China National Biotec Group Company Limited. Active, not recruiting at 1 site in China. 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 1/2, Interventional, and Prevention
This is a non-randomized, open-label, externally controlled study to evaluate the safety and immnunogenicity of the Omicron COVID-19 Vaccine (Vero Cell), Inactivated in population aged 18 years old and above with no vaccination history of the COVID-19 vaccine. 200 health subjects will be recruited in this study, including 150 aged 18-59 years old and 50 aged 60 years old and above. All subjects will be received 2 doses of Omicron COVID-19 Vaccine (Vero Cell), Inactivated according to the immunization schedule of 0, 21-28 days. The change in neutralizing antibody level at 28 days after the second dose was used to determine whether to receive a further booster dose for ≥3 months.
The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed. In addition, blood samples will be collected on Day 0 before vaccination,Day 14 after dose 1, before dose 2 and on day 14, 28 and month 3, 6, 9, 12 after dose 2. Serum antibody levels, cellular immune responses will be analyzed.
7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.
This study's enrollment of 280 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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
Biological: Omicron COVID-19 Vaccine (Vero Cell), Inactivated
2 doses of vaccine according to the immunization schedule of 0, 21-28 days
The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 28 after Dose 2
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 28 after Dose 2
Incidence of adverse reactions
Time frame: within 28 days after vaccination
The Geometric Mean Titer (GMT) of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 14 after Dose 2
The four-fold increase rate of neutralizing antibody against Omicron SARS-CoV-2
Time frame: On Day 14 after Dose 2
The incidence of any adverse reactions/events
Time frame: 28 days after each immunization
The incidence of serious adverse events (SAE) and adverse events special interest (AESI)
Time frame: From the beginning of the first dose to 12 months after the second immunization
The neutralizing antibody GMT
Time frame: on 3rd month, 6th month, 9th month, and 12th month after Dose 2
The proportion of subjects of neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64
Time frame: on 3rd month, 6th month, 9th month, and 12th month after Dose 2
The neutralizing antibody GMT to different variants of SARS-CoV-2
Time frame: On Day 28 after Dose 2
The IgG antibody lever against Omicron SARS-CoV-2
Time frame: On Day 14 and 28 after Dose 2
The incidence of COVID-19 cases
Time frame: From 14 day after Dose 2
The incidence of severe cases of COVID-19, including deaths accompanied by COVID-19)
Time frame: From 14 day after Dose 2
Plan to share: No
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for Oct 2023, 17 months after the start.
Of 80 industry-sponsored phase 1/2 interventional studies under COVID-19, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's planned 17 months is above that.
Counting every sponsor, half of 187 studies reached it within 11 months; a quarter within 4 and three quarters within 20.
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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