COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-005197-25/DE

BioNTech SE - Regulatory Affairs Strategist

regulatory@biontech.de

2021-11-29

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

Participants are eligible to be included in the study only if all of the substudy-specific inclusion criteria are met. For Substudy A, see Section 10.7.5.1. of the Study Protocol. For Substudy B, see Section 10.8.5.1. of the Study Protocol. For Substudy C, see Section 10.9.5.1. of the Study Protocol. For Substudy D, see Section 10.10.5.1. of the Study Protocol. For Substudy E, see Section 10.11.5.1. of the Study Protocol. For Substudy F, see Section 10.12.5.1. of the Study Protocol. Some inclusion criteria are common to all substudies: participants (and their parent(s)/legal guardian(s) willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures, participants should be healthy, and participants (or their parent[s]/legal guardian[s]) must be capable of giving personal signed informed consent.

Participants are excluded from the study if any of the substudy-specific exclusion criteria apply. Some exclusion criteria are common to all substudies: participants with medical or psychiatric conditions that may increase the risk of study participation, history of severe adverse reactions associated with a vaccine and/or severe allergic reaction to any component of the study vaccination, previous clinical or microbiological diagnosis of COVID-19, immunocompromised individuals, or participants with bleeding diathesis. For Substudy A, see Section 10.7.5.2. of the Study Protocol. For Substudy B, see Section 10.8.5.2. of the Study Protocol. For Substudy C, see Section 10.9.5.2. of the Study Protocol. For Substudy D, see Section 10.10.5.2. of the Study Protocol. For Substudy E, see Section 10.11.5.2. of the Study Protocol. For Substudy F, see Section 10.12.5.2. of the Study Protocol.

2

BioNTech SE

12

100

Brazil;Israel;South Africa;United States;Germany

Healthy volunteers

N/A

51

Substudy A - Please refer to Section 10.7.3. of the Protocol. Substudy B Primary Safety - Troponin I level - Local reactions (pain at the injection site, redness, and swelling) - Systemic events (fever, fatigue/tiredness, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) - AEs - SAEs Substudy C Primary Efficacy - Local reactions (pain at the injection site, redness, and swelling) - Systemic events (fever, fatigue/tiredness, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain) - AEs - SAEs Primary Immunogenicity - SARS-CoV-2 reference-strain neutralizing titers Substudy D: - Please refer to Section 10.10.3 of the Protocol. Substudy E - Please refer to Section 10.11.3. of the protocol. Substudy F - Please refer to Section 10.12.3. of the protocol.

Declared number of arm (25.0) differs from found arms (2.0)

Phase 3

[{"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]