SARS-CoV2 InfectionPhase 3COVID-19NCT04508075
Efficacy, Safety and Immunogenicity Study of SARS-CoV-2 Inactivated Vaccine
A Phase 3 study testing SARS-CoV-2 vaccine (inactivated) in people with SARS-CoV2 Infection, run by PT Bio Farma at 1 site in Indonesia.
Trial summary
This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- SARS-CoV-2 vaccine (inactivated)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,620 participants
- Where
- 1 siteIndonesia
- Study dates
- 10 Aug 2020to 31 Aug 2021
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically healthy adults aged 18 - 59 years.
- Subjects have been informed properly regarding the study and signed the informed consent form.
- Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
Who cannot join
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- Contact with novel coronavirus infected persons (positive for nucleic acid detection) within 14 days prior to the trial.
- Contact to patients with fever or respiratory symptoms surrounding areas or from communities with reported cases within 14 days prior to the trial.
- Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial.
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
- The result of RT-PCR of swab nasopharyngeal is positive
Show all 15Show fewer
- Reactive IgG and IgM for SARS-CoV-2 (by standardize rapid test).
- Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
- History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
- History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
- Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
- Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (> 2 weeks)).
- Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome
- Subjects receive any vaccination within 1 month before and after IP immunization.
- Subjects plan to move from the study area before the end of study period.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Hasan Sadikin Hospital/School of Medicine, Padjadjaran University
Bandung, West Java
About this study
Official title: A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia
This phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation
Read the detailed description
This trial is Randomized, observer-blind, placebo-controlled two arms parallel group, prospective intervention study
Approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy evaluation. Subjects will be divided into 2 treatment arms that are the vaccinated group and placebo group with ratio 1:1. The vaccinated arms will be grouped into three different lot number (lot 1/lot 2/ lot 3) of SARS-CoV-2 vaccine.
- Conditions
- SARS-CoV2 Infection
- Being tested
- SARS-CoV-2 vaccine (inactivated), Placebo
- Keywords
- vaccine, SARS-CoV-2, infection
- Medical subject headings
- COVID-19, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 vaccine (inactivated)Biological
SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac
PlaceboBiological
Placebo manufactured by PT. Bio Farma
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 Vaccine | Experimental | Participants receive 2 doses of SARS-CoV-2 Inactivated Vaccine with 14 days interval, intramuscularly Receives: Biological: SARS-CoV-2 vaccine (inactivated) |
| Placebo | Placebo comparator | Participants receive 2 doses of placebo with 14 days interval, intramuscularly Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of laboratory-confirmed COVID-19 after the second dose
Percentage of laboratory-confirmed COVID-19 cases
Measured: 14 days to 6 months after the second dose
Secondary outcomes (6)
Incidence of suspected COVID-19 cases
Percentage of suspected COVID-19 cases
Measured: within 14 days to 6 months after the second dose.
Incidence of laboratory-confirmed cases (severe, critical and death)
Percentage of laboratory-confirmed cases (severe, critical, death)
Measured: within 14 days to 6 months after the second dose
Seroconversion rate anti-S antibody IgG titer (ELISA)
Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches
Measured: 14 days after two doses of vaccination
Seroconversion rate anti-S antibody IgG titer (ELISA)
Percentage of subjects with four-fold increasing anti-S antibody IgG titer (ELISA) compare to baseline and between batches
Measured: 6 months after two doses of vaccination
Seropositive rate of neutralizing antibodies
Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches
Measured: 14 days after two doses of vaccination
Seropositive rate of neutralizing antibodies
Percentage of subjects with four-fold increasing serum neutralizing antibody compared to baseline and between batches
Measured: 6 months after two doses of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start10 Aug 2020
- Primary completion9 Jan 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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
- Model description
- Subjects 18-59 years of age: Randomized, observer blind, placebo-controlled two arms parallel group, prospective intervention study, to evaluate efficacy, safety, immunogenicity SARS-CoV-2 vaccine (inactivated)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- PT Bio Farma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universitas Padjadjaran, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, Sinovac Life Sciences Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508075
- Sponsor's protocol ID
- CoV2-0320
- Acronym
- COVID-19
- Status last verified
- Dec 2021
- First submitted
- 7 Aug 2020
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Observer-blind, Randomized, Placebo-controlled Study of the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Inactivated Vaccine in Healthy Adults Aged 18-59 Years in Indonesia
- ClinicalTrials.gov ID
- NCT04508075
- Acronym / sponsor ID
- COVID-19 / CoV2-0320
- Conditions
- SARS-CoV2 Infection
- Keywords
- vaccine, SARS-CoV-2, infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,620 participants (actual)
- Lead sponsor
- PT Bio FarmaIndustry (pharma, biotech, devices)
- Collaborators
- Universitas Padjadjaran, National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, Sinovac Life Sciences Co., Ltd.
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 9 Jan 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 11 Aug 2020 (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 phase III trial aims to assess the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine (inactivated) and lot-to-lot consistency evaluation
Detailed description
This trial is Randomized, observer-blind, placebo-controlled two arms parallel group, prospective intervention study
Approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy evaluation. Subjects will be divided into 2 treatment arms that are the vaccinated group and placebo group with ratio 1:1. The vaccinated arms will be grouped into three different lot number (lot 1/lot 2/ lot 3) of SARS-CoV-2 vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Subjects 18-59 years of age: Randomized, observer blind, placebo-controlled two arms parallel group, prospective intervention study, to evaluate efficacy, safety, immunogenicity SARS-CoV-2 vaccine (inactivated)
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 Vaccine | Experimental | Biological: SARS-CoV-2 vaccine (inactivated)Participants receive 2 doses of SARS-CoV-2 Inactivated Vaccine with 14 days interval, intramuscularly |
| Placebo | Placebo comparator | Biological: PlaceboParticipants receive 2 doses of placebo with 14 days interval, intramuscularly |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinically healthy adults aged 18 - 59 years.
- Subjects have been informed properly regarding the study and signed the informed consent form.
- Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.
Key exclusion criteria (15 listed)
- Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
- Contact with novel coronavirus infected persons (positive for nucleic acid detection) within 14 days prior to the trial.
- Contact to patients with fever or respiratory symptoms surrounding areas or from communities with reported cases within 14 days prior to the trial.
- Two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial.
- Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
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 |
|---|---|---|
| SARS-CoV-2 vaccine (inactivated)SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac | Biological | SARS-CoV-2 Vaccine |
| PlaceboPlacebo manufactured by PT. Bio Farma | Biological | Placebo |
Primary outcome
Incidence of laboratory-confirmed COVID-19 after the second dose
Time frame: 14 days to 6 months after the second dose
Percentage of laboratory-confirmed COVID-19 cases
6 secondary outcomes
Incidence of suspected COVID-19 cases
Time frame: within 14 days to 6 months after the second dose.
Incidence of laboratory-confirmed cases (severe, critical and death)
Time frame: within 14 days to 6 months after the second dose
Seroconversion rate anti-S antibody IgG titer (ELISA)
Time frame: 14 days after two doses of vaccination
Seroconversion rate anti-S antibody IgG titer (ELISA)
Time frame: 6 months after two doses of vaccination
Seropositive rate of neutralizing antibodies
Time frame: 14 days after two doses of vaccination
Seropositive rate of neutralizing antibodies
Time frame: 6 months after two doses of vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Interim ResultLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for SARS-CoV2 Infection
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SARS-CoV-2 vaccine (inactivated) in people with SARS-CoV2 Infection, run by PT Bio Farma at 1 site in Indonesia.
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 3 inclusion and 15 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: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of laboratory-confirmed COVID-19 after the second dose (time frame: 14 days to 6 months after the second 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 13 Jan 2022.