Safety and Immunogenicity of SARS CoV-2 mRNA vaccine platform in healthy Thai adolescent

ational Vaccine Institute0 个研究点目标入组 120 人开始时间: 2021年9月17日最近更新: 2024年8月19日

适应症

试验速览

Healthy adolescents had good immune responses to the fractional dose regimen of BNT162b2 and this may be considered as an alternative option.

•1. Participants must age 12 to <18 years old.
•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, physical examination (including vital signs), and the clinical judgment of the investigator.
•4. Participants must be able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
•5. Participants and/or parent(s) or legally authorized representative(s) must sign a written informed consent form, including any required privacy authorization form, prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.

•1. Known anaphylaxis to any of the trial vaccine components (including excipients of the trial vaccines) or drugs.
•2. Participants with previous documented SARS-CoV-2 infection within 6 months of first vaccination.
•3. Receipt of immunoglobulins or blood products within 3 months of first vaccination.
•4. Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial.
•5. 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.
•6. Participants who are pregnant or breastfeeding.
•7. Presence of any acute illness required medical attention within 14 days of first vaccination.
•8. Participants with body mass index more than 35 kg/m2

发起方

ational Vaccine Institute