COVID-19Phase 3NCT05156632
Efficacy,Immunogenicity and Safety of COVID-19 Vaccine , Inactivated Booster Dose in Adults Aged 18 Years and Above
A Phase 3 study testing Medium-dosage COVID-19 Vaccine,Inactivated and High-dosage COVID-19 Vaccine,Inactivated in people with COVID-19, run by Sinovac Research and Development Co., Ltd..
Trial summary
This is a multi-center, case-driven, randomized, double-blinded, and placebo-controlled Phase Ⅲb clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the efficacy of the booster dose after two doses of CoronaVac® against RT-PCR confirmed… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Medium-dosage COVID-19 Vaccine,Inactivated and High-dosage COVID-19 Vaccine,Inactivated
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2023to 20 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged 18 years and above, who have received 2 prior doses of CoronaVac® with an interval between those doses of 21-56 days, with the second dose given 5-8 months prior to the day of vaccination in the present study;
- The participants are able to understand and sign the informed consent voluntarily;
- Female participants who have a negative pregnancy test on the day of vaccination, and not currently breastfeeding;
- Must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.
Who cannot join
- History of confirmed infection of SARS-CoV-2 prior to randomization;
- Any prior administration of another investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
- Allergy to vaccines or vaccine/placebo ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
- Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
- Receipt of blood/plasma products or immunoglobulins in the past 3 months before vaccination;
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- Participation in other studies involving study intervention within 30 days prior to vaccination;
- Receipt of attenuated live vaccines in the past 14 days prior to vaccination;
- Receipt of inactivated or subunit vaccines in the past 7 days prior to vaccination;
- Acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma, migraine, gastrointestinal disorder, etc);
- Acute febrile illness with axillary temperature >37.5°C on the day of vaccination; enrollment could be considered if the fever is absent for 72 hours prior to vaccination;
- According to the investigator's judgment, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk to the participant due to participation in the study
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲb Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated Booster Dose in Adults Aged 18 Years and Above
This is a multi-center, case-driven, randomized, double-blinded, and placebo-controlled Phase Ⅲb clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the efficacy of the booster dose after two doses of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 18 years and above.
Read the detailed description
This is a multi-center, case-driven, randomized, double-blinded, and placebo-controlled Phase Ⅲb clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the efficacy of the booster dose after two doses of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 18 years and above.A total of 13,800 participants aged 18 years and above, who have received 2 doses CoronaVac® in an interval between 21-56 days will be enrolled.Participants will be enrolled and randomly assigned into 3 groups at a ratio of 1:1:1 to receive a booster dose of medium-dose or high-dose COVID-19 Vaccine or placebo 5-8 months after their second dose.Efficacy assessments will include the surveillance for COVID-19-like symptoms, the laboratory confirmation of SARS-CoV-2 infection by RT-PCR, and recording of COVID-19-related hospitalizations.All participants will be monitored for immediate reactions (within 30 minutes) after the booster dose vaccination, adverse events of special interest (AESIs) and serious adverse events (SAEs) for 6 months after booster dose inoculation. In addition,participants in reactogenicity subgroup will be monitored for local and systemic solicited adverse events (AEs) within 7 days and the unsolicited AEs within 28 days.Immunogenicity assessments will be determined by neutralizing and anti-SARS-CoV-2 S-protein antibodies in subgroup participants. The participants in the immunogenicity subgroup will be in the reactogenicity subgroup as well.
- Conditions
- COVID-19
- Being tested
- Medium-dosage COVID-19 Vaccine,Inactivated, High-dosage COVID-19 Vaccine,Inactivated, Placebo-comparator group
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium-dosage COVID-19 Vaccine,InactivatedBiological
Also called Medium-dose CoronaVac®
The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection.
High-dosage COVID-19 Vaccine,InactivatedBiological
Also called High-dose CoronaVac®
The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
Placebo-comparator groupBiological
Also called Placebo (aluminum hydroxide)
The composition is aluminium hydroxide with no antigen ,0 SU/0.5 mL,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension.
| Study group | Role | What they receive |
|---|---|---|
| Medium-dose group | Experimental | 4800 participants including 3400 participants aged 18-59 years ,1200 participants aged 60 years and above who have received 2 doses of CoronaVac® (medium-dose COVID-19 Vaccine) in an interval between 21-56 days will receive a booster dose of medium-dose COVID-19 Vaccine 5-8 months after their second dose. Receives: Biological: Medium-dosage COVID-19 Vaccine,Inactivated |
| High-dose group | Experimental | 4800 participants including 3400 participants aged 18-59 years,1200 participants aged 60 years and above who have received 2 doses of CoronaVac® (medium-dose COVID-19 Vaccine) in an interval between 21-56 days will receive a booster dose of high-dose COVID-19 Vaccine 5-8 months after their second dose. Receives: Biological: High-dosage COVID-19 Vaccine,Inactivated |
| Placebo group | Placebo comparator | 4800 participants including 3400 participants aged 18-59 years,1200 participants aged 60 years and above who have received 2 doses of CoronaVac® (medium-dose COVID-19 Vaccine) in an interval between 21-56 days will receive a booster dose of placebo 5-8 months after their second dose. Receives: Biological: Placebo-comparator group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy index -COVID-19 incidence
COVID-19 incidence per 100 person-years of follow-up based on laboratory confirmed cases in participants aged 18 years and above, 6 months after booster dose
Measured: 6 months after booster dose
Secondary outcomes (5)
Efficacy index -Confirmed hospitalized/severe/death incidence of COVID-19
Confirmed hospitalized/severe/death COVID-19 incidence per 100 person-years of follow-up based on laboratory confirmed cases, 6 months after booster dose
Measured: 6 months after booster dose
Safety index-Local reactions
Local reactions for up to 7 days after booster dose
Measured: Up to 7 days after booster dose
Safety index-Systemic events
Systemic events for up to 7 days after booster dose
Measured: Up to 7 days after booster dose
Safety index-AEs
AEs for up to 28 days after booster dose
Measured: Up to 28 days after booster dose
Safety index-SAEs
SAEs for up to 6 months after booster dose
Measured: Up to 6 months after booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start20 Feb 2023 (estimated)
- Primary completion20 Feb 2023 (estimated)
- Study completion20 Feb 2023 (estimated)
Why it stopped: The plan has changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Research and Development Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javed Khan, Master, Principal investigator, Rehman Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156632
- Sponsor's protocol ID
- PRO-nCOV-3003
- Status last verified
- Feb 2023
- First submitted
- 12 Dec 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲb Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated Booster Dose in Adults Aged 18 Years and Above
- ClinicalTrials.gov ID
- NCT05156632
- Acronym / sponsor ID
- PRO-nCOV-3003
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The plan has changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sinovac Research and Development Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (estimated)
- Primary completion
- 20 Feb 2023 (estimated)
- Study completion
- 20 Feb 2023 (estimated)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, case-driven, randomized, double-blinded, and placebo-controlled Phase Ⅲb clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the efficacy of the booster dose after two doses of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 18 years and above.
Detailed description
This is a multi-center, case-driven, randomized, double-blinded, and placebo-controlled Phase Ⅲb clinical trial of COVID-19 Vaccine manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the efficacy of the booster dose after two doses of CoronaVac® against RT-PCR confirmed symptomatic COVID-19 cases in participants aged 18 years and above.A total of 13,800 participants aged 18 years and above, who have received 2 doses CoronaVac® in an interval between 21-56 days will be enrolled.Participants will be enrolled and randomly assigned into 3 groups at a ratio of 1:1:1 to receive a booster dose of medium-dose or high-dose COVID-19 Vaccine or placebo 5-8 months after their second dose.Efficacy assessments will include the surveillance for COVID-19-like symptoms, the laboratory confirmation of SARS-CoV-2 infection by RT-PCR, and recording of COVID-19-related hospitalizations.All participants will be monitored for immediate reactions (within 30 minutes) after the booster dose vaccination, adverse events of special interest (AESIs) and serious adverse events (SAEs) for 6 months after booster dose inoculation. In addition,participants in reactogenicity subgroup will be monitored for local and systemic solicited adverse events (AEs) within 7 days and the unsolicited AEs within 28 days.Immunogenicity assessments will be determined by neutralizing and anti-SARS-CoV-2 S-protein antibodies in subgroup participants. The participants in the immunogenicity subgroup will be in the reactogenicity subgroup as well.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medium-dose group | Experimental | Biological: Medium-dosage COVID-19 Vaccine,Inactivated4800 participants including 3400 participants aged 18-59 years ,1200 participants aged 60 years and above who have received 2 doses of CoronaVac® (medium-dose COVID-19 Vaccine) in an interval between 21-56 days will receive a booster dose of medium-dose COVID-19 Vaccine 5-8 months after their second dose. |
| High-dose group | Experimental | Biological: High-dosage COVID-19 Vaccine,Inactivated4800 participants including 3400 participants aged 18-59 years,1200 participants aged 60 years and above who have received 2 doses of CoronaVac® (medium-dose COVID-19 Vaccine) in an interval between 21-56 days will receive a booster dose of high-dose COVID-19 Vaccine 5-8 months after their second dose. |
| Placebo group | Placebo comparator | Biological: Placebo-comparator group4800 participants including 3400 participants aged 18-59 years,1200 participants aged 60 years and above who have received 2 doses of CoronaVac® (medium-dose COVID-19 Vaccine) in an interval between 21-56 days will receive a booster dose of placebo 5-8 months after their second dose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults aged 18 years and above, who have received 2 prior doses of CoronaVac® with an interval between those doses of 21-56 days, with the second dose given 5-8 months prior to the day of vaccination in the present study;
- The participants are able to understand and sign the informed consent voluntarily;
- Female participants who have a negative pregnancy test on the day of vaccination, and not currently breastfeeding;
- Must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.
Key exclusion criteria (12 listed)
- History of confirmed infection of SARS-CoV-2 prior to randomization;
- Any prior administration of another investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
- Allergy to vaccines or vaccine/placebo ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
- Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medium-dosage COVID-19 Vaccine,InactivatedAlso: Medium-dose CoronaVac®The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection. | Biological | Medium-dose group |
| High-dosage COVID-19 Vaccine,InactivatedAlso: High-dose CoronaVac®The COVID-19 vaccine,inactivated was manufactured by Sinovac Research\& Development Co., Ltd.1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection. | Biological | High-dose group |
| Placebo-comparator groupAlso: Placebo (aluminum hydroxide)The composition is aluminium hydroxide with no antigen ,0 SU/0.5 mL,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension. | Biological | Placebo group |
Primary outcome
Efficacy index -COVID-19 incidence
Time frame: 6 months after booster dose
COVID-19 incidence per 100 person-years of follow-up based on laboratory confirmed cases in participants aged 18 years and above, 6 months after booster dose
5 secondary outcomes
Efficacy index -Confirmed hospitalized/severe/death incidence of COVID-19
Time frame: 6 months after booster dose
Safety index-Local reactions
Time frame: Up to 7 days after booster dose
Safety index-Systemic events
Time frame: Up to 7 days after booster dose
Safety index-AEs
Time frame: Up to 28 days after booster dose
Safety index-SAEs
Time frame: Up to 6 months after booster dose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javed Khan, Master principal investigator
Rehman Medical Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medium-dosage COVID-19 Vaccine,Inactivated and High-dosage COVID-19 Vaccine,Inactivated in people with COVID-19, run by Sinovac Research and Development Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy index -COVID-19 incidence (time frame: 6 months after booster dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.