Clinical Trials Logo

Clinical Trial Summary

This trial has two parts. Part A and Part B. Due to changes in the overall clinical development plan, Part B will no longer be conducted. The objectives originally described for Part B have been implemented in the ongoing development via a pivotal Phase I/II/III trial BNT162-02/C4591001 (ClinicalTrials.gov NCT: 04368728). Part A is for dose ranging of four different vaccines (BNT162a1, BNT162b1, BNT162b2, and BNT162c2) which will be undertaken with dose escalation and de-escalation plus the evaluation of interim dose levels. It also includes dose ranging in older participants. The vaccines BNT162a1, BNT162b1, BNT162b2, and BNT162c2 will be administered using a Prime/Boost (P/B) regimen. The vaccine BNT162c2 will also be administered using a Single dose (SD) regimen. Three additional cohorts aged from 18 to 85 years receiving BNT162b2 only. BNT162b2 has entered a Phase II/III evaluation of efficacy, with the intent to support an application for marketing authorization. The dosing regimen under investigation is two BNT162b2 doses given ~21 d apart.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04380701
Study type Interventional
Source BioNTech SE
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date April 23, 2020
Completion date April 2023

See also
  Status Clinical Trial Phase
Completed NCT04074928 - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects Phase 3
Completed NCT03321968 - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults Phase 3
Completed NCT04644484 - A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety Phase 3
Completed NCT00984945 - Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults Phase 1
Completed NCT00734175 - Safety of and Immune Response to Recombinant Live-Attenuated Influenza H6N1 Virus Vaccine Vaccine Phase 1
Completed NCT00516035 - Single Group Study of the Safety of and Immune Response to a Bird Flu Vaccine (H7N3) in Healthy Adults Phase 1
Active, not recruiting NCT05284097 - Ad26.ZEBOV, MVA-BN-Filo Vaccination in Children and Adults Previously Vaccinated With Control in the EBOVAC-Salone Study Phase 2
Completed NCT03739112 - Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly Phase 3
Recruiting NCT06113757 - Investigation of Efficacy and Safety of Electrical Signal Therapy Provided by Dr Biolyse® Device in COVID-19 Disease N/A
Completed NCT01991587 - Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults Phase 1/Phase 2
Completed NCT03294135 - The Aim of This Study is to Investigate the Persistence of Antibody Response in Adults up to 15 Years After One Booster Dose of GlaxoSmithKline (GSK) Biologicals' Encepur Adults Vaccine Phase 4
Active, not recruiting NCT02545517 - A Clinical Study to Evaluate Immune Responses to Rabies Vaccine in Adults Who Received Different Primary Rabies Vaccination Regimens Phase 3
Active, not recruiting NCT05619770 - Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects Phase 1
Not yet recruiting NCT01289301 - Studying the Effect of Changing Immunosuppression in Case of Polyoma BK Virus Infection of the Renal Transplant Phase 4
Active, not recruiting NCT01055990 - Basic and Clinical Research on Applying Blood Fix to Treat Critical H1N1 Patients Phase 2
Completed NCT01842997 - Safety of H1N1 Influenza Vaccination in Pregnant Women Phase 4
Completed NCT00980447 - Immunogenicity, Safety and Optimal Dose Finding Study of Recombinant Influenza H5N1 Vaccine in Healthy Young Adults Phase 2
Completed NCT00380237 - Safety of and Immune Response to a Bird Flu Virus Vaccine (H9N2) in Healthy Adults (Study B) Phase 1
Completed NCT00219453 - Pilot Safety Study to Determine the Ability of the Protector Cap Jet Injector to Prevent Cross-Contamination Phase 1
Completed NCT02548078 - A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children Phase 2