Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05107375 |
Other study ID # |
IIT-LKM-2021-NCV01 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
September 3, 2021 |
Est. completion date |
March 4, 2022 |
Study information
Verified date |
June 2023 |
Source |
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Popular topic:Clinical study of recombinant Novel Coronavirus vaccine (CHO cell) combined
with influenza vaccine. Research purpose:Main purpose:To evaluate the immunogenicity of
recombinant Novel Coronavirus vaccine (CHO cells) combined with influenza vaccine in people
aged 18 years and over. Secondary purpose:To evaluate the safety of recombinant Novel
Coronavirus vaccine (CHO cells) combined with influenza vaccine in people aged 18 years and
over. Overall design:An open experimental design was adopted in this study, and 300 subjects
were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel
Coronavirus vaccine (CHO cells) in combination with influenza vaccine. Study population:The
study involved people 18 years of age and older.
Test groups:A total of 300 cases were enrolled. 240 patients in 18-59 years old group, 60
patients in ≥60 years old group. There were 150 cases in group A, 120 cases in 18-59 years
old group, and 30 cases in ≥60 years old group. There were 150 cases in group B, 120 cases in
18-59 years old group and 30 cases in ≥60 years old group.
Description:
Overall design:An open experimental design was adopted in this study, and 300 subjects were
planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel
Coronavirus vaccine (CHO cells) in combination with influenza vaccine.
Intervention:
Group A: one dose of influenza virus split vaccine and one dose of recombinant Novel
coronavirus vaccine (CHO cells) in the contralateral arm on day 0, the second dose of
recombinant Novel coronavirus vaccine (CHO cells) on day 30, and the third dose of
recombinant Novel coronavirus vaccine (CHO cells) on day 60 were given intramuscularly in the
upper arm deltoid muscle.
Group B: the first dose of recombinant Novel coronavirus vaccine (CHO cells) was administered
on day 0, the second dose of recombinant Coronavirus vaccine (CHO cells) on day 30, the first
dose of influenza virus lysate vaccine on day 44, and the third dose of recombinant
Coronavirus vaccine (CHO cells) on day 60.
One dose of recombinant Novel Coronavirus vaccine (CHO cells) was administered at 0.5mL each
dose, containing 25μg nCP-RBD protein. Influenza virus lysis vaccine, one dose at a time,
each dose 0.5mL, containing each influenza virus strain hemagglutinin 15μg.
Immunogenicity observation:
Evaluation of immunogenicity In group A, about 5.0mL of venous blood was collected for
immunogenicity test before the first dose of vaccine, before the second dose of Novel
Coronavirus vaccine (CHO cells) and 14 days after the third dose of recombinant Novel
Coronavirus vaccine (CHO cells).
In group B, about 5.0mL of venous blood was collected for immunogenicity test before the
first dose of vaccine and 14 days after the third dose of recombinant Novel Coronavirus
vaccine (CHO cells).
Safety assessment
AE and SAE
All adverse events (AE), all AE at 30 min after each dose of recombinant Novel Coronavirus
vaccine (CHO cells) and influenza vaccine, all AE at 0-7 days (both solicitation and
non-solicitation AE) and all AE at 8-30 days (non-solicitation AE) were collected; All SAE
were collected from the first dose to 1 month after full immunization.
Solicitation AE[the following events occurring within 7 days after vaccination with
recombinant Novel Coronavirus vaccine (CHO cells)] :
Inoculation site (local) AE: pain, swelling, induration, redness, rash, pruritus Vital signs:
fever Non-inoculated site (whole body) AE: headache, fatigue/fatigue, diarrhea, nausea,
vomiting, muscle pain (non-inoculated site), acute allergic reaction, cough
Vital signs and physical examination
All subjects shall have their axillary body temperature checked daily during the screening
period, before the subsequent dose of recombinant Novel Coronavirus vaccine (CHO cells), and
within 7 days after each dose of recombinant Novel Coronavirus vaccine (CHO cells); Subjects
in group B will have their armpit temperature measured before influenza vaccination (the day
of vaccination).
All subjects underwent physical examination (skin and cardiopulmonary auscultation) and blood
pressure measurement during the screening period.
Pregnancy event
Urine pregnancy test should be performed on women of childbearing age before each dose of
recombinant Novel Coronavirus vaccine (CHO cells); Women of childbearing age in group B
should have a urine pregnancy test prior to influenza vaccination.
Pregnancy events occurring within 1 month from the first dose of vaccine to full immunization
were collected.
ADE/VED risk monitoring
After vaccination (at least 1 dose of trial vaccine) (at each visit), subjects will be
reminded to contact the investigator in case of fever and/or respiratory symptoms (e.g.,
dyspnea, sore throat, etc.), suspected or confirmed cases of COVID-19 occurring during the
study period. If the subjects are suspected or confirmed to be infected with SARS-COV-2
during the trial period, they should go to a local designated hospital for diagnosis and
treatment. A detailed case-by-case investigation is required for confirmed cases. In the
event of severe COVID-19 infection or death, an expert meeting should be held to evaluate
ADE/VED.