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A Study to Evaluate the Safety and Immunogenicity of Ad5-nCoV and Ad5-nCoV-IH in CoronaVac Immunized Children and Adolescents

NCT05169008 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2023-06-15

No results posted yet for this study

Summary

This is a multicenter, randomized, and open-label study to evaluate the immune responses and safety profiles of children aged 6-12 years and adolescents aged 13-17 years receiving Ad5-nCoV (intramuscular injection) or Ad5-nCoV-IH (nebulized inhalation) ≥ 90 days after receiving two doses of CoronaVac.

Conditions

Interventions

BIOLOGICAL

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)

Intramuscular injection

BIOLOGICAL

Recombinant COVID-19 vaccine (adenovirus type 5 vector) for Inhalation (Ad5-nCoV-IH)

Nebulized inhalation through the mouth

Sponsors & Collaborators

  • Beijing Institute of Biotechnology

    collaborator OTHER

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Stephania Passalacqua · Hospital Base de Osorno, Chile

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-02-25
Primary Completion
2023-01-13
Completion
2023-01-13

Countries

  • Chile

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 NCT05169008 on ClinicalTrials.gov