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Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2（COVID-19） Phase I Clinical Trial (3~17 Years Old)

NCT04961359 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

  • Coronavirus

Interventions

BIOLOGICAL

Recombinant new coronavirus vaccine (CHO cell) group

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

BIOLOGICAL

Recombinant new coronavirus vaccine (CHO cells) placebo group

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

Sponsors & Collaborators

  • Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-03
Primary Completion
2021-12-12
Completion
2023-04-06

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04961359 on ClinicalTrials.gov