CompletedNCT05107375Updated Jun 8, 2023

Clinical Study of Recombinant Novel Coronavirus（COVID-19） Vaccine (CHO Cell) Combined With Influenza Vaccine

A Phase 3 interventional study of Tetravalent influenza virus lysis vaccine and Recombinant new coronavirus vaccine (CHO cell) group in Coronavirus Disease 2019, sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-08.

Sponsored by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (part of Chongqing Zhifei Biological Products Co., Ltd.) · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 299
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed 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.

Conditions studied

Coronavirus Disease 2019

Browse trials for

COVID-19 7,774

Keywords

Recombinant Novel Coronavirus Vaccine
Tetravalent influenza virus lysis vaccine

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 299 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. is the lead sponsor of 48 studies on the registry; 3 are open to participants now.

Browse Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. studies →All Chongqing Zhifei Biological Products Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Healthy subjects aged 18 and above with full capacity for civil conduct, who can provide valid identification;
The subjects voluntarily agree to participate in the study and sign the informed consent to understand and comply with the requirements of the study protocol;
Fertile men and women of reproductive age did not have sex from day 1 of the last menstrual cycle to day 1 of the study, or did not have sex using effective contraceptive methods and did not experience contraceptive failure (examples of contraceptive failure include male condom rupture during sex). At the same time, subjects agreed to take effective contraceptive measures for 1 month from the signing of informed consent to the full immunization and no pregnancy plans during this period.

Exclusion criteria

Exclusion Criteria:

History of novel coronavirus infection confirmed or asymptomatic infected persons or positive nucleic acid test of novel Coronavirus;
SARS virus history;
For those with fever, axillary temperature ≥37.3℃ on the day of inclusion;
A past history of severe allergy to any vaccine, or to the active ingredient of the test vaccine, any inactive ingredient, or substance used in the manufacturing process, including aluminum preparations, egg protein, neomycin, formaldehyde, tritonX-100, such as: Acute anaphylaxis, dyspnea, angioneurotic edema, etc., or allergies during previous vaccinations of the same kind;
Patients with uncontrolled epilepsy and other serious neurological diseases (e.g., transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.);
Patients with acute diseases, or acute episodes of chronic diseases, or uncontrolled severe chronic diseases (such as hypertension that cannot be controlled by drugs, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
Patients at the active stage of autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, sjogren's syndrome, etc.), patients with congenital or acquired immune deficiency, HIV infection with opportunistic infection or uncontrolled malignant tumor, lymphoma and leukemia;
No spleen, or splenic operation history;
Received immunomodulators within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical use (such as ointments, eye drops, inhalants or nasal sprays) is allowed;
Has received blood or blood-related products, including immunoglobulin (including rabies immunoglobulin and tetanus immunoglobulin), within 3 months prior to experimental vaccine vaccination; Or planned use of the experimental vaccine within 1 month of vaccination;
If subunit vaccine and inactivated vaccine are administered within 7 days prior to experimental vaccine inoculation, live attenuated vaccine shall be administered within 14 days prior to experimental vaccine inoculation;
Lactating women or pregnant women (including women of childbearing age with positive urine pregnancy test);
Those who have participated in or are participating in clinical trials related to COVID-19, or are participating in clinical trials of other drugs, or have received COVID-19 vaccines; The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk; Subjects cannot meet the requirements of the program; Conditions that interfere with the assessment of vaccine response.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 299 participants (actual)

Study arms

Experimental
Population Ⅰ
One dose of influenza virus split vaccine and one dose of recombinant Novel coronavirus vaccine (CHO cells) were given 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, all in the upper arm deltoid muscle.
Biological: Tetravalent influenza virus lysis vaccine · Biological: Recombinant new coronavirus vaccine (CHO cell) group
Experimental
Population Ⅱ
The first dose of recombinant Novel Coronavirus vaccine (CHO cells) was given 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, all in the upper arm deltoid muscle.
Biological: Tetravalent influenza virus lysis vaccine · Biological: Recombinant new coronavirus vaccine (CHO cell) group

Interventions

BiologicalTetravalent influenza virus lysis vaccine
Influenza virus lysis vaccine, one dose at a time, each dose 0.5mL, containing each influenza virus strain hemagglutinin 15μg.
BiologicalRecombinant new coronavirus vaccine (CHO cell) group
One dose of recombinant Novel Coronavirus vaccine (CHO cells) was administered at 0.5mL each dose, containing 25μg nCP-RBD protein.

What researchers measure

Primary outcomes

Primary endpoint:
Positive conversion rate of SARS-COV-2 neutralizing antibody at day 14 after full inoculation of recombinant Novel Coronavirus vaccine (CHO cells).
Time frame: 14 days after vaccination

Secondary outcomes

Secondary endpoint:
SARS-cov-2 neutralizing antibody GMT on day 14 after full immunization with recombinant Novel Coronavirus vaccine (CHO cells);
Time frame: 14 days after vaccination
Secondary endpoint:
HI antibody GMT, positive conversion rate and serum protection rate of influenza virus typing 30 days after influenza vaccination;
Time frame: 1 months after full vaccination
Secondary endpoint:
Incidence of adverse reactions/events at each time point after each dose of recombinant Novel Coronavirus vaccine (CHO cells) (at least 30 min, 0-7 days and 8-30 days after inoculation);
Time frame: 1 months after full vaccination
Secondary endpoint:
Incidence of adverse reactions/events within 30 minutes of influenza vaccination;
Time frame: within 30 minutes of influenza vaccination
Secondary endpoint:
Incidence of all serious adverse events (SAE) and incidence of vaccine-related SAE from the first dose of recombinant Novel Coronavirus vaccine (CHO cells) to 1 month after full vaccination.
Time frame: 1 months after full vaccination

Study locations

1 site

Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan 411228, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2021 to primary completion in Mar 2022, 6 months.

Of 157 industry-sponsored phase 3 interventional studies under COVID-19, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 15. This study's 6 months is below that.

Counting every sponsor, half of 436 studies reached it within 9 months; a quarter within 5 and three quarters within 17.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 1, 2021
First posted: Nov 4, 2021
StartActual: Sep 3, 2021
Primary completionActual: Mar 4, 2022
CompletionActual: Mar 4, 2022
Last update: Jun 8, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05107375
Lead sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Responsible party: Sponsor
First posted: Nov 4, 2021
Start date: Sep 3, 2021
Primary completion: Mar 4, 2022
Completion: Mar 4, 2022
Last update: Jun 8, 2023

Study contacts

Tao Huang

principal investigator · Hunan Provincial Center for Disease Control and Prevention

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: CHO cell

Other studies in this condition

COVID-19 →

Other studies from this sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. →

Start the discussion