Virus Diseases Clinical Trial
Official title:
A Multi-site, Phase I/II, 2-Part, Dose-Escalation Trial Investigating the Safety and Immunogenicity of Four Prophylactic SARS-CoV-2 RNA Vaccines Against COVID-2019 Using Different Dosing Regimens in Healthy and Immunocompromised Adults
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.
n/a
| 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 |