COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005442-42/PL

BioNTech SE - Regulatory Affairs Strategist

Ruben.Rizzi@biontech.de

2021-08-11

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

Age and Sex: 1. Male or female participants ≥6 months to <12 years of age, at the time of randomization, at Visit 1. 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 included. 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’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’s legal guardian (as defined in Appendix 1) and the participant’s assent, when applicable, before any study-specific 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.

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. 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. 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 permitted. 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: Not applicable. Other Exclusions: 16. Participants who are direct descendants (child or grandchild) of investigational site staff members or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

2

BioNTech SE

0

12

Finland;Poland;Spain;United States;Germany

Healthy volunteers

N/A

290

Phase 1: • Participants ≥5 to <12 years and ≥2 to <5 years of age: • Local reactions (pain at the injection site, redness, and swelling) • Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) • AEs • SAEs Participants ≥6 months to <2 years of age: • Local reactions (tenderness at the injection site, redness, and swelling) • Systemic events (fever, decreased appetite, drowsiness, and irritability) • AEs • SAEs Phase 2/3 Primary Safety: Participants ≥5 to <12 years and ≥2 to <5 years of age: • Local reactions (pain at the injection site, redness, and swelling) • Systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) • AEs • SAEs Participants ≥6 months to <2 years of age: • Local reactions (tenderness at the injection site, redness, and swelling) • Systemic events (fever, decreased appetite, drowsiness, and irritability) • AEs • SAEs Primary Immunogenicity: •SARS-CoV-2 neutralizing titers

Declared number of arm (5.0) differs from found arms (2.0)

Phase 1/Phase 2/Phase 3

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