This is a randomized, double-blind, active-controlled phase Ⅲ clinical trial.The purposeof this study is to evaluate the immunogenicity and safety of one booster dose oftrivalent COVID-19 vaccine (vero cell), inactivated, prototype strain, delta strain andomicron strain in healthy people aged 3 years old and above and have completed two orthree doses of CoronaVac® in Colombia.
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®.
Biological: Trivalent COVID-19 Vaccine (Vero Cell), Inactivated, Prototype Strain, Delta Strain and Omicron Strain
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.
Other Name: Trivalent COVID-19 vaccine
Biological: COVID-19 Vaccine (Vero Cell), Inactivated
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.
Other Name: CoronaVac®
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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;
- 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.
Clinica de la Costa
Barranquilla, Colombia
Investigator: Andrés Cadena, Doctor
Andrés Cadena, Doctor
(+ 57) 3369999
acadena@clinicadelacosta.co
Andrés Cadena, Doctor, Principal Investigator
Clinica de la Costa