EUCTR2020-005442-42-FI进行中（未招募）1 期
A PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBOCONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV 2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDRE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BioNTech SE
- 入组人数
- 11,666
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age and Sex:
- •1. Male or female participants between =6 months and <12 years of age, at the time of randomization, at Visit 1 for the dose-finding/selected-dose evaluation
- •For the obtaining-serum samples-for-potential-troponin I testing portion of the study:
- •Male or female participants between =5 and <16 years of age.
- •Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1)
- •and female (Section 10.4.2) participants.
- •Type of Participant and Disease Characteristics:
- •2. Participants' parent(s)/legal guardian(s) and participants, as age
- •appropriate, who are willing and able to comply with all scheduled visits,
- •treatment plan, laboratory tests, lifestyle considerations, and other
- •study procedures.
- •3. Healthy participants who are determined by medical history, physical
- •examination, and clinical judgment of the investigator to be eligible for
- •inclusion in the study.
- •Note: Healthy participants with preexisting stable disease, defined as
- •disease not requiring significant change in the therapy or hospitalization
- •for worsening disease during the 6 weeks before enrollment, can be
- •Phase 2/3: Specific criteria for such participants with known stable
- •infection with HIV, HCV, or HBV can be found in Section 10.7.
- •4. Participants are expected to be available for the duration of the study
- •and whose parent(s)/legal guardian can be contacted by telephone
- •during study participation.
- •5. Negative urine pregnancy test for female participants who are
- •biologically capable of having children.
- •6. Female participant of childbearing potential or male participant able to
- •father children who is willing to use a highly effective method of
- •contraception as outlined in this protocol for at least 28 days after the
- •last dose of study intervention if at risk of pregnancy with her/his
- •partner; or female participant not of childbearing potential or male
- •participant not able to father children.
- •Informed Consent:
- •7. The participant or participant's parent(s)/legal guardian is capable of
- •giving signed informed consent as described in Appendix 1, which
- •includes compliance with the requirements and restrictions listed in the
- •ICD and in this protocol. Depending on the age of the participant and
- •according to local requirements, participants will also be asked to
- •provide assent as appropriate (verbal or written).
- •The investigator, or a person designated by the investigator, will obtain
- •written or electronically signed informed consent (and assent) from each
- •study participant or participant's legal guardian (as defined in Appendix
- •1) and the participant's assent, when applicable, before any studyspecific
- •activity is performed. All legal guardians should be fully
- •informed, and participants should be informed to the fullest extent
- •possible, about the study in language and terms they are able to
- •understand. The investigator will retain the original copy of each
- •participant's signed consent/assent document.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 11666
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- 另有 2 项未显示
排除标准
- •Medical Conditions:
- •1. Phase 1 only: Past clinical (based on COVID-19 symptoms/signs
- •alone, if a SARS CoV 2 NAAT result was not available) or microbiological
- •(based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT
- •result) diagnosis of COVID 19.
- •2. Phase 1 only: Known infection with HIV, HCV, or HBV.
- •3. Receipt of medications intended to prevent COVID-19.
- •4. Previous or current diagnosis of MIS-C.
- •5. Other medical or psychiatric condition including recent (within the
- •past year) or active suicidal ideation/behavior or laboratory abnormality
- •that may increase the risk of study participation or, in the investigator's
- •judgment, make the participant inappropriate for the study. Note: This
- •includes both conditions that may increase the risk associated with
- •study intervention administration or a condition that may interfere with
- •the interpretation of study results
- •6. History of severe adverse reaction associated with a vaccine and/or
- •severe allergic reaction (eg, anaphylaxis) to any component of the study
- •intervention(s).
- •7. Immunocompromised individuals with known or suspected
- •immunodeficiency, as determined by history and/or laboratory/physical
- •examination.
- •8. Individuals with a history of autoimmune disease or an active
- •autoimmune disease requiring therapeutic intervention, including but
- •not limited to systemic lupus erythematosus. Note: Stable type 1
- •diabetes and hypothyroidism are permitted.
- •9. Bleeding diathesis or condition associated with prolonged bleeding
- •that would, in the opinion of the investigator, contraindicate
- •intramuscular injection.
- •10. Female who is pregnant or breastfeeding.
- •Prior/Concomitant Therapy:
- •11. Previous vaccination with any coronavirus vaccine.
- •12. Individuals who receive treatment with immunosuppressive therapy,
- •including cytotoxic agents or systemic corticosteroids, eg, for cancer or
- •an autoimmune disease, or planned receipt throughout the study. If
- •systemic corticosteroids have been administered short term (<14 days)
- •for treatment of an acute illness, participants should not be enrolled into
- •the study until corticosteroid therapy has been discontinued for at least
- •28 days before study intervention administration. Inhaled/nebulized,
- •intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are
- •13. Receipt of blood/plasma products, immunoglobulin, or monoclonal
- •antibodies, from 60 days before study intervention administration, or
- •receipt of any passive antibody therapy specific to COVID-19 from 90
- •days before study intervention administration, or planned receipt
- •throughout the study.
- •Prior/Concurrent Clinical Study Experience:
- •14. Participation in other studies involving study intervention within 28
- •days prior to study entry and/or during study participation.
- •15. Previous participation in other studies involving study intervention
- •containing LNPs.
- •Diagnostic Assessments:
- 另有 6 项未显示
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