Clinical trial NCT04863638: A Immuno-bridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated
Official title: A Immunobridging and Immunization Schedules Study of COVID-19 Vaccine (Vero Cell), Inactivated in Population Aged ≥ 60 Years Old and 3-17 Years Old Compared With That in Population Aged 18-59 Years Old
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Covid19
Keywords: SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Beijing Institute of Biological Products Co Ltd.
First posted: 2021-04-28
Enrollment: 4400
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules compared to that in population aged 18-59 years old with 2-dose schedule. And subjects in the same age are randomly assigned to different immunization schedule groups.

Detailed description: This trial is a randomized study to evaluate the immunogenicity of COVID-19 Vaccine (Vero Cell), Inactivated and in population aged 60 years old and 3-17 years old with different schedules (D0,21,42, D0, 21,111,or D0,21,171)compared to that in population aged 18-59 years old with 2-dose schedule (D0,21). And subjects in the same age are randomly assigned to different immunization schedule groups.

Eligibility criteria: Inclusion Criteria:

* Aged 3 years and above (after enrolled, subjects will be allocated according to age).
* By asking for medical history and physical examination, the health condition judged by the investigators is well.
* Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
* No vaccination history of COVID-19 vaccine before enrollment.
* Be able and willing to complete the whole prescribed study plan.
* With self-ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the protocol.

Exclusion Criteria:

* Confirmed cases, suspected cases or asymptomatic infections of SAR-CoV-2 infection (check "China Disease Prevention and Control Information System").
* Has a history of SARS, MERS infection (self-report, on-site inquiry).
* \>14-year-old subjects axillary temperature ≥37.3℃, ≤14-year-old subjects axillary temperature ≥37.5℃.
* Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
* With severe liver diseases, severe kidney diseases, uncontrollable hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), diabetic complications, malignant tumors, various acute diseases, or acute attack period of chronic diseases.
* Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
* Has a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
* With congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
* Has a history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease).
* Received immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days).
* Received live attenuated vaccinewithin 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
* Received blood products within 3 months before enrolment.
* Received other research drugs within 6 months before enrolment.
* Other circumstances judged by investigators are not suitable for this clinical trial.

Primary outcomes:
measure: The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
timeFrame: 14 days after the full course immunization
measure: The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
timeFrame: 14 days after the full course immunization
Secondary outcomes:
measure: The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
timeFrame: 14 days after the second dose in schedule of Day 0,21,42
measure: The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
timeFrame: 14 days after the second dose in schedule of Day 0,21,42
measure: The Geometric Mean Titer (GMT) of anti-SARS-CoV-2 neutralizing antibody
timeFrame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
measure: The four-fold increase rate of anti-SARS-CoV-2 neutralizing antibody
timeFrame: before the third dose in schedules of Day 0,21,111 and Day 0,21,171
measure: Immune Persistence
timeFrame: 3 months, 6 months, 12 months after the full course immunization
measure: Safety index-Incidence of adverse reactions
timeFrame: From the beginning of the vaccination to 28 days after the full course immunization
measure: Safety index-Incidence of serious adverse events
timeFrame: From the beginning of the vaccination to 6 months after the full course immunization
Other outcomes:
measure: Immune Persistence
timeFrame: 18 months and 24 months after the full immunization
Locations:
city: Xinxiang
country: China
facility: Yanjin County Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Provincial Center for Disease Control and Prevention
name: Yanxia Wang, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: