Clinical trials: completed, sponsored by BioNTech SE
SARS-CoV-2 Infection, COVID-19
To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.
Substudy A: The study will evaluate the safety, tolerability, and efficacy of a booster dose of BNT162b2 when administered to participants having previously received 2 doses of BNT162b2 at least 6 months prior to randomization.
- Trial name
- NCT04955626
- Testing
- BNT162b2, BNT162b2 OMI, Combination BNT162b2 and BNT162b2 OMI
- Where
- 154 sites in United States, Brazil and 3 more
- Volunteers
- 16,372 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals
The purpose of this clinical trial is to learn about the safety, tolerability and immunogenicity of BNT162b RNA-based SARS-CoV-2 vaccine candidates in adults to prevent COVID-19.
- Trial name
- NCT05472038
- Testing
- BNT162b5 Bivalent (WT/OMI BA.2), BNT162b2 Bivalent (WT/OMI BA.1), BNT162b2 Bivalent (WT/OMI BA.4/BA.5)
- Where
- 31 sites in United States
- Volunteers
- 1,453 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Solid Tumor
Dose Escalation Trial of BNT152+153 in Patients With Cancer
This is an open-label, multisite Phase I dose escalation, safety, pharmacokinetics (PK) and pharmacodynamics (PD) trial of BNT152+153 in various solid tumor indications.
- Trial name
- NCT04710043
- Testing
- BNT152, BNT153
- Where
- 7 sites in United States, Czechia
- Volunteers
- 86 people
- Sponsor
- BioNTech SE
Malaria
Safety and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This first-in-human clinical trial, was a dose escalation multi-center trial designed to assess the safety, tolerability, and immunogenicity of the vaccine component, BNT165b1, a ribonucleic acid (RNA)-lipid nanoparticle (LNP)…
- Trial name
- NCT05581641
- Testing
- BNT165b1
- Where
- 5 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Influenza, Human, COVID-19
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi…
- Trial name
- NCT05596734
- Testing
- bivalent BNT162b2 (original/Omi BA.4/BA.5), qIRV (22/23), QIV
- Where
- 59 sites in United States
- Volunteers
- 1,019 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older
Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability…
- Conditions
- SARS-CoV-2 Infection, COVID-19, Maternal Immunization
- Trial name
- NCT04754594
- Testing
- BNT162b2
- Where
- 90 sites in United States, Brazil and 3 more
- Volunteers
- 726 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Safety and Immunogenicity of RNA-based Vaccines Against SARS-CoV-2 Variants in Healthy Participants
This trial consisted of three parts, Part A, Part B, and Part C, and evaluated the safety and immunogenicity of a third (booster) injection of the multivalent vaccine BNT162b2 (B.1.1.7 + B.1.617.2), and the safety and…
- Conditions
- SARS-CoV-2 Infection, COVID-19, SARS-CoV-2 Acute Respiratory Disease, SARS (Disease)
- Trial name
- NCT05004181
- Testing
- BNT162b2, Multivalent BNT162b2 (B.1.1.7 + B.1.617.2), Monovalent BNT162b2 (B.1.1.7)
- Where
- 35 sites in United States, Germany and 2 more
- Volunteers
- 1,380 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID19
Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants ≥2 Years
This is a 4 dose study with 124 participants (7 adults ,117 children). Adults are considered to be participants 18 years of age or older. Participants are going to be enrolled based on conditions that make them immunocompromised.
- Trial name
- NCT04895982
- Testing
- BNT162b2
- Where
- 29 sites in United States, Brazil and 2 more
- Volunteers
- 124 people
- Sponsor
- BioNTech SE
COVID-19, SARS-CoV-2 Infection
A Trial Investigating the Safety and Effects of One or Two Additional Doses of Comirnaty or One Dose of BNT162b2s01 in BNT162-01 or BNT162-04 Trial Subjects
Trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 (Variant of concern [VOC] strain B.1.351) in BNT162-01 trial participants, or two boosting doses of Comirnaty in…
- Trial name
- NCT04949490
- Testing
- BNT162b2s01, BNT162b2
- Where
- 4 sites in Germany
- Volunteers
- 137 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Infections, Respiratory, Virus Diseases
A Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 in Healthy and Immunocompromised Adults
Originally, the study was planned to include two parts, i.e., Part A and Part B, however Part B was cancelled due to changes in the overall clinical development plan.
- Conditions
- Infections, Respiratory, Virus Diseases, Infection Viral, Vaccine Adverse Reaction
- Trial name
- NCT04380701
- Testing
- BNT162a1, BNT162b1, BNT162b2
- Where
- 5 sites in Germany
- Volunteers
- 512 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Safety and Immunogenicity of BNT162b2 Coadministered With SIIV in Adults 18 Through 64 Years of Age
This study will assess the safety and immunogenicity of a fourth dose (booster) of BNT162b2 when coadministered with SIIV compared to separate administration of the vaccines when given 1 month apart (SIIV followed by BNT162b2)…
- Trial name
- NCT05310084
- Testing
- BNT162b2, Seasonal Inactivated Influenza Vaccine
- Where
- 26 sites in Australia, New Zealand
- Volunteers
- 1,134 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Covid-19, Protection Against COVID-19
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
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.
- Trial name
- NCT04537949
- Testing
- BNT162b3
- Where
- 2 sites in Germany
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects
This was a phase I, randomized, placebo-controlled, observer-blind study, for evaluation of safety and immunogenicity of SARS-CoV-2 mRNA vaccine (BNT162b1) in Chinese healthy population.
- Trial name
- NCT04523571
- Testing
- BNT162b1
- Where
- China
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against…
- Trial name
- NCT04588480
- Testing
- BNT162b2
- Where
- 2 sites in Japan
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior.
- Trial name
- NCT04816669
- Testing
- BNT162b2
- Where
- 21 sites in United States
- Volunteers
- 629 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
This is a Phase 3, randomized, observer-blind study in healthy individuals. The primary study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate (BNT162b2): As a 30-microgram dose…
- Trial name
- NCT04713553
- Testing
- BNT162b2, BNT162b2.B.1.351
- Where
- 17 sites in United States
- Volunteers
- 1,574 people, healthy volunteers welcome
- Sponsor
- BioNTech SE