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IH Convidecia as Second Booster Dose Against Breakthrough Infections

NCT05517642 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2023-09-08

No results posted yet for this study

Summary

This will be a randomized single-blind controlled trial to determine the immunogenicity, efficacy and safety of IH Convidecia (CanSino), as a second booster vaccination against Omicron and other emerging VOCs to prevent breakthrough infections among people with a sub-optimal immune response to the first booster dose.

These subjects will be randomized in a ratio of 1:1 to receive a second booster dose of IH Convidecia vaccine (treatment arm), or a second booster dose of mRNA vaccine BNT162b2 (Pfizer).

Conditions

Interventions

BIOLOGICAL

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

Subjects will be randomized to receive a second booster dose of IH Convidecia vaccine (treatment arm)

BIOLOGICAL

mRNA vaccine BNT162b2 (Pfizer)

Subjects will be randomized to receive a second booster dose of BNT162b2.

Sponsors & Collaborators

  • CanSino Biologics Inc.

    lead INDUSTRY

Principal Investigators

  • Sharon Shi Min Ng · Hospital Ampang

  • Norliza Zainudin · Hospital Selayang

  • Sunita Bavanandam · Kuala Lumpur General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2023-05-02
Completion
2023-05-02

Countries

  • Malaysia

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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 NCT05517642 on ClinicalTrials.gov