A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
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ClinicalTrials.gov Identifier: NCT04537949 |
Recruitment Status :
Completed
First Posted : September 3, 2020
Results First Posted : March 24, 2022
Last Update Posted : March 24, 2022
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Sponsor:
BioNTech SE
Information provided by (Responsible Party):
BioNTech SE
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Tracking Information | |||||||
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First Submitted Date ICMJE | September 2, 2020 | ||||||
First Posted Date ICMJE | September 3, 2020 | ||||||
Results First Submitted Date ICMJE | February 14, 2022 | ||||||
Results First Posted Date ICMJE | March 24, 2022 | ||||||
Last Update Posted Date | March 24, 2022 | ||||||
Actual Study Start Date ICMJE | September 9, 2020 | ||||||
Actual Primary Completion Date | March 12, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults | ||||||
Official Title ICMJE | A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of a Prophylactic SARS-CoV-2 RNA Vaccine (BNT162b3) Against COVID-19 Using Different Dosing Regimens in Healthy Adults | ||||||
Brief Summary | Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was skipped due to changes in the overall clinical development plan. The conducted Part A was a dose-finding part to investigate the optimal dose, allowing dose adjustments upwards and downwards in younger participants. Doses tested in older participants were chosen based on acceptability of dosing in younger participants. | ||||||
Detailed Description | This study was a multi-site, Phase I/II, open-label, dose-escalation study. The study included the first in human dose and dose ranging groups in healthy younger participants (aged 18 to 55 years [yrs]) and older participants (aged 56 to 85 yrs). The conducted Part A followed a dose escalation design. Discretionary dose de-escalation and refinement was also planned. Study participants with the first-in-human [FIH] immunization and any subsequent dose escalation cohorts were immunized using a sentinel dosing/subject staggering. For any dose de-escalation or dose-refinement cohorts in younger adults, i.e., cohorts with doses lower than previously tested, participants were dosed using a subject staggering process. Cohorts in older participants were optional and dependent on acceptability of dosing in younger participants. Part A consisted of a treatment phase (screening to Visit 7) and a follow-up phase (Visits 8 to 10). | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE |
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Intervention ICMJE | Biological: BNT162b3
Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen).
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
96 | ||||||
Original Estimated Enrollment ICMJE |
120 | ||||||
Actual Study Completion Date ICMJE | February 7, 2022 | ||||||
Actual Primary Completion Date | March 12, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
OR For older adult cohorts, volunteers must be aged 56 to 85 years, have a body mass index over 19 kg/m^2 and under 30 kg/m^2 (i.e., be neither underweight nor obese), and weigh at least 50 kg at Visit 0.
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04537949 | ||||||
Other Study ID Numbers ICMJE | BNT162-04 2020-003267-26 ( EudraCT Number ) U1111-1254-4840 ( Other Identifier: WHO Universal Trial Number (UTN) ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | BioNTech SE | ||||||
Original Responsible Party | BioNTech RNA Pharmaceuticals GmbH | ||||||
Current Study Sponsor ICMJE | BioNTech SE | ||||||
Original Study Sponsor ICMJE | BioNTech RNA Pharmaceuticals GmbH | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | BioNTech SE | ||||||
Verification Date | March 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |