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Clinical Evaluation for Batch Consistency of Ad5-nCoV in Chinese Healthy Adults

NCT05313646 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1050

Last updated 2022-04-06

No results posted yet for this study

Summary

This is a randomized, double-blind, parallel-controlled, equivalence trial, for evaluation of safety and immunogenicity, and batch-to-batch consistency of a recombinant adenovirus type-5-vectored Covid-19 vaccine Convidecia in one shot schedule in Chinese healthy adults aged 18 years and above. In total 1050 healthy adults will be recruited in this study. Subjects in both cohort will be randomized stratified into two cohort by age(18\~59 years and≥60 years) in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia. The primary objective is to test the equivalence of the immune responses to three consecutive manufacturing lots of Convidecia in healthy adults. The secondary objectives were to evaluate the immunogenicity and safety of Convidecia for each lot and the pooled data of three lots)

Conditions

Interventions

BIOLOGICAL

batch 1 of Ad5-nCoV

The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101001. It contains 5×10\^10 viral particles per 0.5 mL in a vial.

BIOLOGICAL

batch 2 of Ad5-nCoV

The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101002. It contains 5×10\^10 viral particles per 0.5 mL in a vial.

BIOLOGICAL

batch 3 of Ad5-nCoV

The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202102003. It contains 5×10\^10 viral particles per 0.5 mL in a vial.

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Principal Investigators

  • Fengcai Zhu, MSc · Jiangsu Provincial Center for Diseases Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2021-04-08
Completion
2021-09-08

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05313646 on ClinicalTrials.gov