MedTrace Logo

Covid-19 Vaccination in Adolescents and Children

NCT04800133 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1018

Last updated 2024-01-16

No results posted yet for this study

Summary

Objectives To assess the reactogenicity, measure the adaptive immune responses and track the long-term immune memory in healthy children and adults as well as pediatric patients receiving the COVID-19 vaccines-BNT162b2, CoronaVac-chosen by the Hong Kong Government; to compare the reactogenicity and immunogenicity across the vaccines used for these children and adults.

Hypothesis to be tested The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines in children are non-inferior to those in adults.

Design and subjects A single-site, comparative nonrandomised clinical trial for 450 healthy individuals or patients under 18 years old and one or both healthy parents and unrelated adults to receive one of COVID-19 vaccines by intramuscular injection (and intradermal injection)

Instruments Mobile app for subjects to record adverse effects, enzyme-linked immunosorbent assay, plaque reduction neutralization assay, luciferase immunoprecipitation system assay and flow cytometry.

Interventions BNT162b2 and CoronaVac, by intramuscular or intradermal route

Main outcome measures Types and frequencies of adverse effects within 7 days, and changes and peaks of antibody levels and antigen-specific memory T cell responses for 3 years.

Conditions

  • Covid19

Interventions

BIOLOGICAL

Tozinameran

mRNA vaccine developed by BioNTech against COVID-19

BIOLOGICAL

CoronaVac

Inactivated virus vaccine developed by SinoVac against COVID-19, intramuscular

BIOLOGICAL

CoronaVac, intradermal

Inactivated virus vaccine developed by SinoVac against COVID-19, intradermal

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Yu Lung Lau, MD · The University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-08
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • China

Study Locations

More Related Trials

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 NCT04800133 on ClinicalTrials.gov