Clinical trials: sponsored by BioNTech SE
SARS-CoV-2 Infection, COVID-19
Safety and Effects of an Investigational COVID-19 Vaccine as Booster in Healthy People
This was an exploratory Phase I, randomized, observer-blind, active-controlled, dose-escalation trial to evaluate four dose levels (DLs) of BNT162b4 given in combination with BNT162b2 Bivalent (original/Omicron BA.4/BA.5) to…
- Trial name
- NCT05541861
- Testing
- BNT162b2 Bivalent (original/Omicron BA.4/BA.5) 30 mcg, BNT162b4 5 mcg, BNT162b4 10 mcg
- Where
- 17 sites in United States
- Volunteers
- 383 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Tuberculosis
Safety and Immune Responses After Vaccination With Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers
This randomized, placebo-controlled, double-blind, safety and dose-finding Phase Ia trial will evaluate four dose levels of the BNT164 investigational vaccines (BNT164a1 and BNT164b1) to select a safe and tolerable dose in a…
- Trial name
- NCT05537038
- Testing
- BNT164a1, BNT164b1
- Where
- 3 sites in Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Influenza, COVID-19
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
The purpose of this study is to understand the safety and effects of a combined influenza and COVID-19 vaccine. This combined vaccine is compared to separate vaccines for the protection against influenza and SARS-CoV-2.
- Trial name
- NCT06178991
- Testing
- Influenza and COVID-19 Combination A, Licensed influenza vaccine, COVID-19 Vaccine
- Where
- 106 sites in United States
- Volunteers
- 8,795 people, healthy volunteers welcome
- Sponsor
- 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
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
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
A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children
The purpose of this clinical trial is to learn about the safety and immune responses of the study vaccine (called a bivalent BNT162b2 Omicron containing vaccine) in healthy infants and children.
- Trial name
- NCT05630352
- Testing
- Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
- Volunteers
- 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