Immunogenicity of 2 dose regimen of BNT162b2 mRNA vaccine in Thai children aged 6 months to 4 years following COVID 19 (COVID-19)

Ratchadaphisek Sompoch Research Fund0 个研究点目标入组 80 人开始时间: 2022年10月18日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Participants must age 6 months to <5 years old on the day of first dose vaccination.
•2.Participants have never received vaccination against SARS-CoV-2 prior to study enrollment.
•3.Participants must be in good health at the time of entry into the trial as determined by medical history, and the clinical judgment of the investigator.
•4.Parent(s) or legally authorized representative(s) gave consent to participants in the trial.
•Group A: Participants have previous symptomatic SARS-CoV-2 infection prior to study enrollment. (Documented by Antigen detection test or PCR at SARS-CoV-2 during July1, 2021 to November30, 2021)
•Group B: Participants have previous symptomatic SARS-CoV-2 infection prior to study enrollment. (Documented by Antigen detection test or PCR at SARS-CoV-2 during February1, 2022 to December31, 2022 (the Omicron predominant Period)
•(Note*: exclude Time overlapping between the Delta and the Omicron predominant periods is during December, 2021 to January, 2022)

•1.Known anaphylaxis to any of the trial vaccine components (including excipients of the trial vaccines) or drugs.
•2.Receipt of immunoglobulins or blood products within 3 months of first vaccination.
•3.Use of or anticipated need to use, within the next 6 months of any medications that may be associated with impaired immune responsiveness or with immunosuppression.
•4.Presence of any acute illness required medical attention within 14 days of first vaccination.

发起方

Ratchadaphisek Sompoch Research Fund