Clinical Trial of Immunogenicity Bridging of a Recombinant New Coronavirus COVID-19 Vaccine (CHO Cell)

  • STATUS
    Recruiting
  • End date
    Mar 28, 2023
  • participants needed
    400
  • sponsor
    Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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Updated on 28 November 2021
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Accepts healthy volunteers

Summary

Popular topic: A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age.

Overall design:Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3~17 and the age of 18~59. The non inferiority hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell).

Study population:400 healthy people aged 3 to 17 years old, both male and female.

Description

Study population:A total of 400 healthy people aged 3 ~ 17 were enrolled (including 130 cases aged 3 ~ 5, 150 cases aged 6 ~ 11, and 120 cases aged 12 ~ 17)both male and female.

Overall design:Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3~17 and the age of 18~59. The non inferiority hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell).

Immunization program: Three doses were inoculated in 0, 1 and 2 months. Dose:25g/0.5mL/dose.

Safety endpoint:

  1. AE and SAE:Collect all adverse events (AES) 30 minutes after each dose of vaccination, all AES 0-7 days (including solicited and non solicited AES), all AES 8-30 days (non solicited AES), and all SAE from the first dose of vaccination to 12 months after the whole course of immunization.
  2. Vital signs and physical examination:

All subjects underwent axillary temperature examination every day during the screening period, before the next dose of vaccination and within 7 days after each dose of vaccination.

All subjects underwent physical examination (skin and cardiopulmonary auscultation) during the screening period.

3. Pregnancy events:

For women of childbearing age, urine pregnancy test should be carried out before each dose of vaccination.

The pregnancy events occurred within 12 months from the first dose of vaccine to the whole course of immunization were collected.

4. ADE / VED risk monitoring:

After vaccination (at least one dose of test vaccine) (at each visit), remind the subjects to contact the investigator in time for fever and / or respiratory symptoms (such as dyspnea, sore throat, etc.) and covid-19 suspected or confirmed cases during the study. If the subject is suspected or confirmed to be infected with sars-cov-2 during the test, he must go to the local Xinguan designated hospital for hospitalization diagnosis and treatment. Detailed case investigation shall be conducted for confirmed cases. In case of severe or dead cases of new crown infection, an expert meeting shall be held to conduct special investigation and evaluate whether it is ADE/ VED.

Details
Condition *COVID-19, Covid-19, Coronavirus Disease 2019
Treatment Recombinant new coronavirus vaccine (CHO cell)
Clinical Study IdentifierNCT05109598
SponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Last Modified on28 November 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

At least 3 ~ 17 years old (both included)
The subject voluntarily agrees to participate in the study, and / or the guardian of the subject voluntarily agrees to the child to participate in the study. The subject himself (8-17 years old) and the guardian sign the informed consent form, and can provide valid identity certificates to understand and comply with the requirements of the test protocol
The subject and / or the guardian of the subject have the ability to understand (non illiterate) the research procedures and promise to participate in regular follow-up according to the research requirements
There is no high or medium risk area, overseas travel history or residence history in the past 14 days; In the past 14 days, no confirmed case of New Coronavirus infection, asymptomatic infection or suspected cases had been found. And there was no contact history of patients with fever or respiratory symptoms from high and medium risk areas in the past 14 days; Personnel in non isolation period
Male and female subjects with fertility agreed to take effective contraceptive measures from the beginning of the study to 2 months after the whole vaccination

Exclusion Criteria

The results of physical examination during screening period are abnormal and clinically significant (not suitable for vaccination) as determined by clinicians
Suspected or confirmed fever within 72 hours before enrollment (including the day of enrollment) (> 14 years old, axillary temperature 37.3 ; 14 years old, axillary temperature 37.5 )
Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, etc; Or have a history of the above serious side effects after the use of any vaccine or drug in the past
had previous history of SARS and SARS-CoV-2
Taking antipyretics or painkillers within 24 hours before the first dose of vaccine
persons who have been vaccinated with New Coronavirus or inoculated with live attenuated vaccine within 7 days or within 7 days before the first dose of vaccine are inoculated with inward subunit vaccine and / or inactivated vaccine
Have received blood or blood related products, including immunoglobulin, within 3 months before the vaccination of the test vaccine; Or planned use during the study
Persons suffering from the following diseases
Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.)
in the past 7 days
Suffering from congenital malformations or developmental disorders, genetic
defects, severe malnutrition, etc
History of congenital or acquired immune deficiency or autoimmune diseases or
receiving immunomodulator treatment within 6 months, such as immunosuppressive
dose of Glucocorticoid (dose reference: equivalent to prednisone 20mg / day
more than one week); Or monoclonal antibody; Or thymosin; Or interferon, etc
However, topical medication (such as ointment, eye drops, inhalants or nasal
sprays) is allowed
It is known that it is diagnosed with infectious diseases, such as active
tuberculosis, viral hepatitis present, human immunodeficiency virus infection
or Treponema pallidum infection
Neurological diseases or neurodysplasia (e.g., convulsions, migraines
epilepsy, stroke, seizures in the last three years, encephalopathy, focal
neurological deficit, Guillain Barre syndrome, encephalomyelitis or transverse
myelitis); History of psychosis or family history
Functional absence of spleen, and absence of spleen or splenectomy for any
reason
There are serious chronic diseases or disease in progress can not be
controlled smoothly, such as diabetes, drugs can not control hypertension
Severe liver and kidney diseases; Respiratory diseases that currently require
daily drug treatment (e.g., chronic obstructive pulmonary disease [COPD]
asthma) or any treatment for aggravation of respiratory diseases (e.g
aggravation of asthma) in the last 5 years; A history of serious
cardiovascular disease (such as congestive heart failure, cardiomyopathy
ischemic heart disease, arrhythmia, conduction block, myocardial infarction
cor pulmonale) or myocarditis or pericarditis
Thrombocytopenia, any coagulation dysfunction or anticoagulant treatment
Cancer patients (except basal cell carcinoma)
\. Lactating women or pregnant women (including women of childbearing age
with positive urine pregnancy test), or women or their partners who have
pregnancy plans within 2 months after the whole vaccination of the test
vaccine
\. Those who have participated or are participating in other clinical
trials, and the relevant visits have not been completed, or are clearly
vaccinated after the completion of the new crown vaccine
\. The researcher believes that the subject has any disease or condition
that may put the subject at unacceptable risk; The subjects were unable to
meet the protocol requirements; Interference with the evaluation of vaccine
response
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