Status:
UNKNOWN
Determining Reactogenicity and Immunogenicity of Delayed COVID-19 Vaccine Schedule in Children
Lead Sponsor:
KK Women's and Children's Hospital
Collaborating Sponsors:
Duke-NUS Graduate Medical School
Conditions:
Vaccine Reaction
COVID-19
Eligibility:
All Genders
5-11 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
BNT162b2 (Pfizer-BioNTech/Comirnaty®) vaccine is a mRNA vaccine that is (26/11/2021) approved for use in adults and adolescents (12 years old and above) under the Pandemic Special Access Route (PSAR) ...
Eligibility Criteria
Inclusion
- Healthy children aged 5 to 11 years old
- No contraindications to mRNA COVID-19 Pfizer-BioNTech vaccines
- Had never received any COVID-19 vaccine before
- Never had previous COVID-19 infections
Exclusion
- Children outside the age group.
- Immunocompromised children.
- Participants with previous history of COVID-19 infection.
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05329064
Start Date
March 24 2022
End Date
December 31 2023
Last Update
April 29 2022
Active Locations (1)
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1
KK Women's and Children's Hospital
Bukit Timah, Singapore, 229899