Clinical trials: completed, sponsored by BioNTech SE
COVID-19, SARS-COV-2 Infection
A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age
This study is designed to find out how well the COVID-19 vaccine protects people 50 to 64, who don't have any serious health problems, compared to a group that receives a vaccine that doesn't contain an ingredient to protect…
- Trial name
- NCT07300839
- Testing
- BNT162b2 Vaccine
- Where
- 196 sites in United States
- Volunteers
- 5,240 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Bacterial Vaginosis
A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis
This was a two-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy (for Part B) of BNT331 in healthy women (Part A) and in women diagnosed…
- Trial name
- NCT06469164
- Testing
- BNT331
- Where
- 6 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Monkeypox
A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
This was a dose-escalation, Phase I/II study evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox…
- Trial name
- NCT05988203
- Testing
- BNT166a
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Malaria
A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria
This was a randomized, dose-escalation Phase I/IIa study to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P.
- Trial name
- NCT06069544
- Testing
- BNT165c, BNT165d
- Where
- 5 sites in United States
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Influenza,Human, COVID-19
A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
This study is to learn about flu and COVID vaccines, either alone or when mixed together. Healthy people aged 18 or older can join. Participants will get one shot in each arm, either a flu or COVID vaccine, alone or mixed.
- Trial name
- NCT06683352
- Testing
- Investigational Influenza Vaccine, COVID-19 Vaccine, Investigational Influenza/COVID-19 Vaccine
- Where
- 22 sites in United States
- Volunteers
- 1,353 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
COVID-19, SARS-COV-2 Infection
A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19, called BNT162b2 (2025/2026 formulation).
- Trial name
- NCT07222384
- Testing
- BNT162b2 (2025/2026 formulation)
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2
A Study to Learn About Variant-Adapted COVID-19 RNA Vaccine Candidate(s) in Healthy Children
The purpose of this clinical trial is to learn about the safety, extent of the side effects, and immune responses of the study vaccine (called variant-adapted BNT162b2 RNA-based vaccine) in healthy children.
- Conditions
- SARS-CoV-2 Virus, Severe Acute Respiratory Syndrome Coronavirus 2, COVID-19
- Trial name
- NCT05543616
- 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
- Where
- 96 sites in United States, Brazil and 3 more
- Volunteers
- 4,338 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
COVID-19, SARS-COV-2 Infection
A Study to Learn About COVID-19 RNA-Based Variant-Adapted Vaccine Candidate(s) Against SARS-CoV-2 in Participants Ages 12 Through 64 Years Considered at Higher Risk of Severe COVID-19, and Participants Ages ≥65 Years
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19.
- Trial name
- NCT07069309
- Testing
- BNT162b2 (2025/2026 recommended SARS-CoV-2 strain)
- Where
- 19 sites in United States
- Volunteers
- 774 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 Children
This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and…
- Trial name
- NCT04816643
- Testing
- Biological/Vaccine: BNT162b2 10mcg, BNT162b2 20mcg, BNT162b2 30mcg
- Where
- 128 sites in United States, Brazil and 4 more
- Volunteers
- 11,837 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy
This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx)…
- Trial name
- NCT04813627
- Testing
- Regular blood sample collection for ctDNA assessment
- Where
- 74 sites in United States, Belgium and 2 more
- Volunteers
- 2,079 people
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
The purpose of this clinical protocol is to learn about the safety, tolerability, and immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of SARS-CoV-2 in healthy people.
- Trial name
- NCT05997290
- Testing
- BNT162b2 (Omi XBB.1.5), BNT162b2 (Omi JN.1), BNT162b2 (Omi KP.2)
- Where
- 37 sites in United States
- Volunteers
- 1,051 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2 Infection, COVID-19
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals
This is a Phase 1/2/3, randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection, and efficacy study in healthy individuals.
- Trial name
- NCT04368728
- Testing
- BNT162b1, BNT162b2, BNT162b2SA
- Where
- 175 sites in United States, Argentina and 4 more
- Volunteers
- 46,969 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
SARS-CoV-2
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population
This was a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population.
- Trial name
- NCT04649021
- Testing
- BNT162b2
- Where
- China
- Volunteers
- 960 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Breast Cancer (Triple Negative Breast Cancer (TNBC))
RNA-Immunotherapy of IVAC_W_bre1_uID and IVAC_M_uID
The Mutanome Engineered RNA Immuno-Therapy (MERIT) study introduced a novel concept for Individualized Cancer Immunotherapy (IVAC®) to treat each patient with the relevant and immunogenic RNA vaccines for a given patient's tumor.
- Trial name
- TNBC-MERIT (NCT02316457)
- Testing
- IVAC_W_bre1_uID, IVAC_W_bre1_uID/IVAC_M_uID
- Where
- 4 sites in Germany, Sweden
- Volunteers
- 42 people
- Sponsor
- BioNTech SE
Melanoma
Evaluation of the Safety and Tolerability of i.v. Administration of a Cancer Vaccine in Patients With Advanced Melanoma
The purpose of this study is to determine the safety and tolerability of intravenous administration of a tetravalent RNA-lipoplex cancer vaccine targeting four tumor-associated antigens in patients with advanced melanoma.
- Trial name
- Lipo-MERIT (NCT02410733)
- Testing
- Lipo-MERIT
- Where
- 4 sites in Germany
- Volunteers
- 119 people
- Sponsor
- BioNTech SE
Influenza, COVID-19 (Coronavirus Disease 2019)
A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People
The purpose of this study is to learn about how the flu and COVID vaccines act when given alone or when mixed together. This study is seeking healthy participants aged 18 or older.
- Trial name
- NCT06821061
- Testing
- Investigational Influenza Vaccine, Investigational COVID-19 Vaccine, Investigational Influenza and COVID-19 Combination Vaccine
- Where
- 31 sites in United States
- Volunteers
- 2,650 people, healthy volunteers welcome
- Sponsor
- 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
Melanoma Stage III, Melanoma Stage IV
A Study to Investigate the Novel Agent BNT111 and Cemiplimab in Combination or as Single Agents in Patients With Advanced Melanoma That Has Not Responded to Other Forms of Treatment
This is an open-label, randomized, multi-site, Phase II, interventional trial designed to evaluate the efficacy, tolerability, and safety of BNT111 + cemiplimab in anti-programmed death protein 1 (PD-1)/anti-programmed death…
- Conditions
- Melanoma Stage III, Melanoma Stage IV, Unresectable Melanoma
- Trial name
- NCT04526899
- Testing
- BNT111, Cemiplimab
- Where
- 49 sites in United States, Australia and 5 more
- Volunteers
- 184 people
- 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