NCT04961359

Brief Summary

Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (3\~17 years old) Research purpose:Main purpose:To evaluate the safety and tolerability of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Secondary purpose: To explore the immunogenicity and persistence of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Overall design:A single center, randomized, blind, placebo-controlled trial design was adopted. Study population: 75 healthy people aged 3 to 17 years old, both male and female. Test groups: 3 to 5 years old: 20 cases in experimental group and 5 cases in placebo group; 6 to 11 years old: 20 patients in the experimental group and 5 patients in the placebo group; 12 to 17 years old: 20 patients in experimental group and 5 patients in placebo group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2021

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

5 months

First QC Date

July 8, 2021

Last Update Submit

April 23, 2023

Conditions

Coronavirus

Keywords

Recombinant Novel Coronavirus Vaccine

Outcome Measures

Primary Outcomes (2)

  • The number of adverse events after intramuscular injection

    The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site.

    12 months after full vaccination

  • Immunogenic end point

    The positive rate of neutralizing antibody, S protein binding antibody (IgG), RBD protein binding antibody (IgG) of all subjects before the first dose, 1 month，3 months and 6 months after the full vaccination. And titer levels and their fold increase before immunity.

    Within 6 months after the last dose of vaccination

Study Arms (6)

Population Ⅰ

EXPERIMENTAL

Population Ⅰ has 20 subjects aged 12 to 17 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. PopulationⅠis intramuscular injection of deltoid muscle of upper arm with vaccine.

Biological: Recombinant new coronavirus vaccine (CHO cell) group

Population Ⅱ

PLACEBO COMPARATOR

Population Ⅱ has 5 subjects aged 12 to 17 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅱ is a placebo intramuscular injection of deltoid muscle of the upper arm.

Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group

Population Ⅲ

EXPERIMENTAL

Population Ⅲ has 20 subjects aged 6 to 11 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅲ is intramuscular injection of deltoid muscle of upper arm with vaccine.

Biological: Recombinant new coronavirus vaccine (CHO cell) group

Population Ⅳ

PLACEBO COMPARATOR

Population Ⅳ has 5 subjects aged 6 to 11 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅳ is a placebo intramuscular injection of deltoid muscle of the upper arm.

Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group

Population Ⅴ

EXPERIMENTAL

Population Ⅴ has 20 subjects aged 3 to 5 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. PopulationⅤ is intramuscular injection of deltoid muscle of upper arm with vaccine.

Biological: Recombinant new coronavirus vaccine (CHO cell) group

Population Ⅵ

PLACEBO COMPARATOR

Population Ⅵ has 5 subjects aged 3 to 5 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅵ is a placebo intramuscular injection of deltoid muscle of the upper arm.

Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group

Interventions

Recombinant new coronavirus vaccine (CHO cell) groupBIOLOGICAL

Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Population ⅠPopulation ⅢPopulation Ⅴ
Recombinant new coronavirus vaccine (CHO cells) placebo groupBIOLOGICAL

Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.

Population ⅡPopulation ⅣPopulation Ⅵ

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Aged 3-17 years old (all inclusive);
  • The subject voluntarily agrees to participate in the study (or the legal guardian of the subject voluntarily agrees the child to participate in the study), and the guardian and the subject (8-17 years old) sign the informed consent form, and can provide valid identification; Understand and comply with test protocol requirements;
  • The subject and / or the legal guardian of the subject have the ability to understand the (non illiterate) study procedure and participate in the planned follow-up;
  • Axillary temperature \< 37.3 ℃ (\> 14 years old), axillary temperature \< 37.5 ℃(≤14 years old);
  • Female and male subjects of childbearing age agreed to take effective contraceptive measures during the study.

You may not qualify if:

  • The results of physical examination and laboratory examination before screening were abnormal and clinically significant;
  • Any component of the test vaccine, including aluminum preparation, has a history of severe allergy, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioneurotic edema, etc; Or the above-mentioned serious adverse reactions occurred after the use of any vaccine or drug in the past;
  • Patients with history of SARS and SARS-CoV-2 (meet any of the following items):
  • ① History of infection or history of SARS and SARS-CoV-2;
  • ② During the epidemic of sras-cov-2, there was a history of contact with patients diagnosed / suspected with new crown;
  • ③ The detection of SARS-CoV-2 IgM and / or IgG antibody was positive;
  • ④ RT-PCR was positive.
  • They had taken antipyretics or analgesics within 24 hours before the first dose of vaccine;
  • those who have been vaccinated with New Coronavirus or inoculated with live attenuated vaccine within 30 days within 14 days before the first dose of the vaccine are inoculated with the subunit vaccine and / or inactivated vaccine;
  • Patients with the following diseases:
  • ① Patients with acute (within 72 hours) febrile diseases (\> 14 years old, axillary temperature ≥ 37.3 ℃; ≤4 years old,axillary temperature ≥37.5 ℃);
  • ② Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;
  • ③ Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
  • ④ A history of congenital or acquired immunodeficiency or autoimmune disease or immunomodulatory therapy 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, local medication (such as ointment, eye drops, inhaler or nasal spray) is allowed;
  • ⑤ Known to be diagnosed with infectious diseases, such as active tuberculosis, viral hepatitis, present or / or human immunodeficiency virus HIV antibody positive or syphilis specific antibody positive, or parents who are HIV infected;
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan Provincial Center for Disease Control and Prevention

Changsha, Hunan, 411228, China

Location

Related Publications (1)

  • Gao L, Li Y, He P, Chen Z, Yang H, Li F, Zhang S, Wang D, Wang G, Yang S, Gong L, Ding F, Ling M, Wang X, Ci L, Dai L, Gao GF, Huang T, Hu Z, Ying Z, Sun J, Zuo X. Safety and immunogenicity of a protein subunit COVID-19 vaccine (ZF2001) in healthy children and adolescents aged 3-17 years in China: a randomised, double-blind, placebo-controlled, phase 1 trial and an open-label, non-randomised, non-inferiority, phase 2 trial. Lancet Child Adolesc Health. 2023 Apr;7(4):269-279. doi: 10.1016/S2352-4642(22)00376-5. Epub 2023 Feb 17.

    PMID: 36803632DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 14, 2021

Study Start

July 3, 2021

Primary Completion

December 12, 2021

Study Completion

April 6, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)