COVID-19Phase 3NCT05433272
Immunogenicity and Safety Study of One Booster Dose of Trivalent COVID-19 Vaccine (Vero Cell), Inactivated
A Phase 3 study testing Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain and COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19, run by Sinovac Biotech (Colombia) S.A.S. at 1 site in Colombia.
Trial summary
This is a randomized, double-blind, active-controlled phase Ⅲ clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of one booster dose of trivalent COVID-19 vaccine (vero cell), inactivated, prototype strain, delta strain and omicron strain in healthy people aged 3 years old and above… Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain and COVID-19 Vaccine (Vero Cell), Inactivated
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteColombia
- Study dates
- 10 Aug 2023to 10 Sep 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy people aged 3 years and above who have completed two or three doses of CoronaVac at least 3 months (≥ 90 days) before (3-8 weeks interval for the first and second dose of CoronaVac, and ≥3 months interval for the second and third dose);
- Participants (and/or their legal guardians for pediatric population) are able to understand and sign the informed consent voluntarily;
- Pregnancy and contraception:
- Female participants of childbearing potential (post-menarche and pre-menopause that has not been undergone any sterilization surgery), who have a negative pregnancy test on the day of booster vaccination in the present study, has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the day of vaccination, and agree to continue adequate contraception through 3 months following the booster vaccination and are not currently breastfeeding; Male participants of childbearing potential who agree to use adequate contraception through 3 months following the booster vaccination (and/or your female partner agree to use an acceptable method of birth control), which include refrain from donating sperm;
- Note 1 :Adequate contraception is defined as consistent and correct use of an approved contraceptive method in accordance with the product label. For example:
- Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide
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- Intrauterine device
- Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route
- Sterilization of a female participant's monogamous male partner prior to entry into the study Note 2 : Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Participants are able to comply with study procedures based on the assessment of the Investigator;
- Participants willing to provide verifiable identification (following the local regulations), to be contacted, and to contact the investigator during the study period.
Who cannot join
- History of confirmed infection of SARS-CoV-2 within 3 months prior to study vaccination；
- With positive test result of SARS-CoV-2 antigen during screening visit;
- Any prior administration of another investigational COVID-19 vaccine or other licensed COVID-19 vaccines, or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
- Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- Serious chronic disease, including but not limited to serious cardiovascular disease, hypertension and diabetes that drugs cannot control, hepatorenal disease, malignant tumor, etc;
- Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
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- Significant chronic central nervous system diseases or neuromuscular disorders, psychosis or severe cognitive behavioral disorder, in the opinion of the investigator, including but not limited to epilepsy, autism spectrum disorder, intellectual disabilities;
- History of autoimmune and/or hematological diseases (including but not limited to systemic lupus erythematosus, thyroidectomy, autoimmune thyroid disease, hematological malignancy, asplenia, functional asplenia, or splenectomy resulting from any condition);
- History of bleeding disorders (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture;
- Receipt of blood/plasma products or immunoglobulins in the past 3 months before vaccination in this study;
- Participation in other studies involving study intervention within 30 days prior to vaccination in this study;
- Receipt of attenuated live vaccines in the past 14 days prior to vaccination in this study;
- Receipt of inactivated or subunit vaccines in the past 7 days prior to vaccination in this study;
- Emerging of chronic diseases or acute exacerbation of stable chronic diseases (including but not limited to asthma, migraine, gastrointestinal disorder, etc.) within 30 days prior to vaccination in this study;
- Acute febrile illness, or body temperature ≥37.8°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 clinical trial results or pose additional risk to the participant due to participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Active-controlled Phase Ⅲ Clinical Trial to Evaluate the Immunogenicity and Safety of One Booster Dose of Trivalent COVID-19 Vaccine (Vero Cell), Inactivated in Healthy People in Colombia
This is a randomized, double-blind, active-controlled phase Ⅲ clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of one booster dose of trivalent COVID-19 vaccine (vero cell), inactivated, prototype strain, delta strain and omicron strain in healthy people aged 3 years old and above and have completed two or three doses of CoronaVac® in Colombia.
Read the detailed description
This is a randomized, double-blind, and active-controlled Phase Ⅲ bridging clinical trial of 1,400 subjects aged 3 years and above and have completed two or three doses of CoronaVac at least 3 months prior to this study.After enrollment, subjects will be randomly assigned into 2 groups at a ratio of 1:1 to receive one dose of trivalent COVID-19 vaccine or CoronaVac®.
- Conditions
- COVID-19
- Being tested
- Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain, COVID-19 Vaccine (Vero Cell), Inactivated
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron StrainBiological
Also called Trivalent COVID-19 vaccine
The Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain was developed by Sinovac Life Science Ltd. The antigen content of trivalent COVID-19 vaccine is a total of 18μg/0.5 ml, including 1200 SU/6 µg/0.5 ml for Prototype strain, 1200 SDU/6 µg/0.5 ml for Delta strain, and 1200 SOU/6 µg/0.5 ml for Omicron strain. The routine of administration is Intramuscular injection into deltoid region.
COVID-19 Vaccine (Vero Cell), InactivatedBiological
Also called CoronaVac®
The COVID-19 Vaccine (Vero Cell),Inactivated was manufactured by Sinovac Life Science Ltd.The antigen content of the active-controlled vaccine (CoronaVac) is 600 SU/3 µg/0.5 ml.The routine of administration is Intramuscular injection into deltoid region.
| Study group | Role | What they receive |
|---|---|---|
| Trial group of participants have received two doses of CoronaVac® | Experimental | 400 participants have received two doses of CoronaVac® at least 3 months prior to this study ,including 150 participants aged 3-17 years old,125 participants aged 18-59 years old and 125 participants aged 60 years and above,will receive one booster dose of trivalent COVID-19 vaccine. Receives: Biological: Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain |
| Control group of participants have received two doses of CoronaVac® | Active comparator | 400 participants have received two doses of CoronaVac® at least 3 months prior to this study ,including 150 participants aged 3-17 years old,125 participants aged 18-59 years old and 125 participants aged 60 years and above,will receive one booster dose of CoronaVac®. Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated |
| Trial group of participants have received three doses of CoronaVac® | Experimental | 300 participants have received three doses of CoronaVac® at least 3 months prior to this study ,including 150 participants aged 18-59 years old and 150 participants aged 60 years and above,will receive one booster dose of trivalent COVID-19 vaccine. Receives: Biological: Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain |
| Control group of participants have received three doses of CoronaVac® | Active comparator | 300 participants have received three doses of CoronaVac® at least 3 months prior to this study ,including 150 participants aged 18-59 years old and 150 participants aged 60 years and above,will receive one booster dose of CoronaVac®. Receives: Biological: COVID-19 Vaccine (Vero Cell), Inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer (GMT) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Geometric Mean Titer (GMT) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac
Measured: At 14 days after one booster dose
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac
Measured: At 14 days after one booster dose
GMT of the neutralizing antibody to SARS-CoV-2 Prototype strain
GMT of the neutralizing antibody to SARS-CoV-2 Prototype strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac.
Measured: At 14 days after one booster dose
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Prototype strain
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Prototype strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac.
Measured: At 14 days after one booster dose
Secondary outcomes (7)
Seropositive rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Seropositive rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac.
Measured: At 14 days after one booster dose
Geometric Mean Fold Rise (GMFR) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Geometric Mean Fold Rise (GMFR) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac
Measured: At 14 days after one booster dose
Seropositive rate of the neutralizing antibody to SARS-CoV-2 Prototype strain
Seropositive rate of the neutralizing antibody to SARS-CoV-2 Prototype strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac
Measured: At 14 days after one booster dose
GMFR of the neutralizing antibody to SARS-CoV-2 Prototype strain
GMFR of the neutralizing antibody to SARS-CoV-2 Prototype strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac.
Measured: At 14 days after one booster dose
Occurrence, intensity, duration, and relationship of solicited local and systemic Adverse Reactions (ARs)
Occurrence, intensity, duration, and relationship of solicited local and systemic Adverse Reactions (ARs) within 7 days after booster vaccination.
Measured: Within 7 days after booster vaccination
Occurrence, intensity, duration, and relationship of unsolicited ARs
Occurrence, intensity, duration, and relationship of unsolicited ARs within 28 days after booster vaccination.
Measured: within 28 days after booster vaccination
Occurrence and relationship of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Occurrence and relationship of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI) within 6 months after booster vaccination.
Measured: Within 6 months after booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start10 Aug 2023 (estimated)
- Primary completion10 Sep 2023 (estimated)
- Study completion10 Sep 2023 (estimated)
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
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech (Colombia) S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sinovac Life Sciences Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Andrés Cadena, Doctor, Principal investigator, Clinica de la Costa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433272
- Sponsor's protocol ID
- PRO-tnCOV-3003
- Status last verified
- Jan 2023
- First submitted
- 21 Jun 2022
- Last updated
- 12 Jan 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 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-controlled Phase Ⅲ Clinical Trial to Evaluate the Immunogenicity and Safety of One Booster Dose of Trivalent COVID-19 Vaccine (Vero Cell), Inactivated in Healthy People in Colombia
- ClinicalTrials.gov ID
- NCT05433272
- Acronym / sponsor ID
- PRO-tnCOV-3003
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Sinovac Biotech (Colombia) S.A.S.Industry (pharma, biotech, devices)
- Collaborators
- Sinovac Life Sciences Co., Ltd.
- Study start
- 10 Aug 2023 (estimated)
- Primary completion
- 10 Sep 2023 (estimated)
- Study completion
- 10 Sep 2023 (estimated)
- First posted
- 27 Jun 2022 (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 randomized, double-blind, active-controlled phase Ⅲ clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of one booster dose of trivalent COVID-19 vaccine (vero cell), inactivated, prototype strain, delta strain and omicron strain in healthy people aged 3 years old and above and have completed two or three doses of CoronaVac® in Colombia.
Detailed description
This is a randomized, double-blind, and active-controlled Phase Ⅲ bridging clinical trial of 1,400 subjects aged 3 years and above and have completed two or three doses of CoronaVac at least 3 months prior to this study.After enrollment, subjects will be randomly assigned into 2 groups at a ratio of 1:1 to receive one dose of trivalent COVID-19 vaccine or CoronaVac®.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trial group of participants have received two doses of CoronaVac® | Experimental | Biological: Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain400 participants have received two doses of CoronaVac® at least 3 months prior to this study ,including 150 participants aged 3-17 years old,125 participants aged 18-59 years old and 125 participants aged 60 years and above,will receive one booster dose of trivalent COVID-19 vaccine. |
| Control group of participants have received two doses of CoronaVac® | Active comparator | Biological: COVID-19 Vaccine (Vero Cell), Inactivated400 participants have received two doses of CoronaVac® at least 3 months prior to this study ,including 150 participants aged 3-17 years old,125 participants aged 18-59 years old and 125 participants aged 60 years and above,will receive one booster dose of CoronaVac®. |
| Trial group of participants have received three doses of CoronaVac® | Experimental | Biological: Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain300 participants have received three doses of CoronaVac® at least 3 months prior to this study ,including 150 participants aged 18-59 years old and 150 participants aged 60 years and above,will receive one booster dose of trivalent COVID-19 vaccine. |
| Control group of participants have received three doses of CoronaVac® | Active comparator | Biological: COVID-19 Vaccine (Vero Cell), Inactivated300 participants have received three doses of CoronaVac® at least 3 months prior to this study ,including 150 participants aged 18-59 years old and 150 participants aged 60 years and above,will receive one booster dose of CoronaVac®. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy people aged 3 years and above who have completed two or three doses of CoronaVac at least 3 months (≥ 90 days) before (3-8 weeks interval for the first and second dose of CoronaVac, and ≥3 months interval for the second and third dose);
- Participants (and/or their legal guardians for pediatric population) are able to understand and sign the informed consent voluntarily;
- Pregnancy and contraception:
- Female participants of childbearing potential (post-menarche and pre-menopause that has not been undergone any sterilization surgery), who have a negative pregnancy test on the day of booster vaccination in the present study, has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the day of vaccination, and agree to continue adequate contraception through 3 months following the booster vaccination and are not currently breastfeeding; Male participants of childbearing potential who agree to use adequate contraception through 3 months following the booster vaccination (and/or your female partner agree to use an acceptable method of birth control), which include refrain from donating sperm;
- Note 1 :Adequate contraception is defined as consistent and correct use of an approved contraceptive method in accordance with the product label. For example:
Key exclusion criteria (16 listed)
- History of confirmed infection of SARS-CoV-2 within 3 months prior to study vaccination；
- With positive test result of SARS-CoV-2 antigen during screening visit;
- Any prior administration of another investigational COVID-19 vaccine or other licensed COVID-19 vaccines, or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
- Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
- Serious chronic disease, including but not limited to serious cardiovascular disease, hypertension and diabetes that drugs cannot control, hepatorenal disease, malignant tumor, etc;
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 |
|---|---|---|
| Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron StrainAlso: Trivalent COVID-19 vaccineThe Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain was developed by Sinovac Life Science Ltd. The antigen content of trivalent COVID-19 vaccine is a total of 18μg/0.5 ml, including 1200 SU/6 µg/0.5 ml for Prototype strain, 1200 SDU/6 µg/0.5 ml for Delta strain, and 1200 SOU/6 µg/0.5 ml for Omicron strain. The routine of administration is Intramuscular injection into deltoid region. | Biological | Trial group of participants have received three doses of CoronaVac®, Trial group of participants have received two doses of CoronaVac® |
| COVID-19 Vaccine (Vero Cell), InactivatedAlso: CoronaVac®The COVID-19 Vaccine (Vero Cell),Inactivated was manufactured by Sinovac Life Science Ltd.The antigen content of the active-controlled vaccine (CoronaVac) is 600 SU/3 µg/0.5 ml.The routine of administration is Intramuscular injection into deltoid region. | Biological | Control group of participants have received three doses of CoronaVac®, Control group of participants have received two doses of CoronaVac® |
Primary outcome
Geometric Mean Titer (GMT) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Time frame: At 14 days after one booster dose
Geometric Mean Titer (GMT) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Time frame: At 14 days after one booster dose
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac
GMT of the neutralizing antibody to SARS-CoV-2 Prototype strain
Time frame: At 14 days after one booster dose
GMT of the neutralizing antibody to SARS-CoV-2 Prototype strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac.
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Prototype strain
Time frame: At 14 days after one booster dose
Seroconversion rate of the neutralizing antibody to SARS-CoV-2 Prototype strain at 14 days after one booster dose of trivalent COVID-19 vaccine or CoronaVac.
7 secondary outcomes
Seropositive rate of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Time frame: At 14 days after one booster dose
Geometric Mean Fold Rise (GMFR) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain
Time frame: At 14 days after one booster dose
Seropositive rate of the neutralizing antibody to SARS-CoV-2 Prototype strain
Time frame: At 14 days after one booster dose
GMFR of the neutralizing antibody to SARS-CoV-2 Prototype strain
Time frame: At 14 days after one booster dose
Occurrence, intensity, duration, and relationship of solicited local and systemic Adverse Reactions (ARs)
Time frame: Within 7 days after booster vaccination
Occurrence, intensity, duration, and relationship of unsolicited ARs
Time frame: within 28 days after booster vaccination
Occurrence and relationship of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Time frame: Within 6 months after booster vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 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.
Andrés Cadena, Doctor principal investigator
Clinica de la Costa
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 Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain and COVID-19 Vaccine (Vero Cell), Inactivated in people with COVID-19, run by Sinovac Biotech (Colombia) S.A.S. at 1 site in Colombia.
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 11 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 12 Jan 2023. 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 Colombia. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrés Cadena, Doctor ((+ 57) 3369999, acadena@clinicadelacosta.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Titer (GMT) of the neutralizing antibody to SARS-CoV-2 Delta strain and Omicron strain (time frame: At 14 days after one booster dose). The study lists 4 primary outcomes in all. 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 12 Jan 2023.