Safety and Immunogenicity of heterologous prime-boost SARS-CoV-2 vaccine with inactivated and mRNA vaccine platforms in healthy Thai adolescent

ational Vaccine Institute0 个研究点目标入组 80 人开始时间: 2021年9月23日最近更新: 2024年8月19日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 80

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

Heterologous prime-boost vaccination with CoronaVac followed by BNT162b2 induced high neutralizing titer against SARS-CoV-2 Delta strain. After 5-month interval, booster with BNT162b2 induced high neutralizing titer against Omicron strain.

研究设计

研究类型: Interventional

入排标准

年龄范围: 12 Years 至 17 Years（—）
性别: All

入选标准

•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.

排除标准

•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

研究者

发起方

ational Vaccine Institute

相似试验

已完成

4 期

Safety and Immunological Responses after COVID-19 vaccination in Thai Pregnant WomePregnancy outcomes following COVID-19 pregnancy in Thai womenCOVID-19, vaccination, pregnant, Thai

TCTR20210717002ational Research Council of Thailand (NRCT)165

已完成

1 期

Immunogenicity to SARS-CoV-2 Omicron variant among school-aged children with 2-dose of inactivated SARS-CoV-2 vaccines followed by BNT162b2 boosterThe immunogenicity and safety of BNT162b2 as a booster dose following fully immunized with inactivated vaccine in Thai children aged 5-11 years.SARS-CoV-2, Inactivated SARS-CoV-2 vaccine, BNT162b2, Children, Booster

TCTR20220330001ational Vaccine Institute60

已完成

3 期

Safety and immunogenicity of heterologous prime/boost inactivated COVID-19 vaccine and viral vector vaccine: an experimental clinical studyImmunogenicityCOVID-19, SARS-CoV-2, Priming effect, Boost, Vaccine, Clinical trial, Antibody, Immunity, Interchangeability

TCTR20210628005ational Research Council of Thailand (NRCT)100

招募中

2 期

Immunogenicity and safety of heterologous prime boost COVID-19 vaccines in ThailandThe immune response after heterologous COVID-19 vaccine administration in healthy volunteers.COVID-19 vaccine, heterologous prime-boost, ChAdOx1, coronavac, Sinovac.

TCTR20210714003Chulabhorn Royal Academy264

已完成

不适用

TRAP VAC TRIAPaediatricsMalaria

PACTR2010020001771828niversity of Oxford30