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Determining Reactogenicity and Immunogenicity of Delayed COVID-19 Vaccine Schedule in Children

NCT05329064 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-04-29

No results posted yet for this study

Summary

COVID-19 vaccine response data in children 5 to 11 years old remain scarce. Our understanding of the safety and immune responses including humoral and cellular responses generated in children remains limited.

Safety of the vaccine is critical in the risk benefit assessment of vaccination in young children. Available data show a trend for increased risk of myocarditis after second dose, especially in males and younger age groups. It is unknown if reduced antigen dose will alter this risk in 5y to \<12y age group. Reassuringly, data from early roll-out in the USA have not reported any safety signals to date. Alternate (reduce dosing or delayed dosing) strategies could help ensure maximum protection with reduced risk of side-effects. There is currently no data available to inform how long protection would last in the reduced dose or delayed dosing strategy.

The trial will inform the potential use of alternate dosing schedules such as single dose or delayed dose to minimise risk and maximise benefit of COVID-19 vaccination in children 5 to 11 years old.

Conditions

  • Vaccine Reaction
  • COVID-19
  • Children, Only

Interventions

BIOLOGICAL

BNT162b2 Pfizer-BioNTech/Comirnaty

The study will use 10mcg of BNT162b2 (Pfizer-BioNTech/Comirnaty®) for each dose. Two doses will be given at 2 months apart between doses.

Sponsors & Collaborators

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Singapore

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 NCT05329064 on ClinicalTrials.gov