Clinical trials: mRNA Vaccine
Quality of Life, Injection Site Reaction
Simultaneous mRNA COVID-19 and IIV4 Vaccination Study
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or…
- Conditions
- Quality of Life, Injection Site Reaction, Adverse Drug Event, Systemic Reaction
- Trial name
- NCT05028361
- Testing
- mRNA COVID-19, IIV4
- Where
- 3 sites in United States
- Volunteers
- 348 people, healthy volunteers welcome
- Sponsor
- Duke University
COVID-19
Phase 3 Adolescent Study for SARS-CoV-2 rS Variant Vaccines
This study is a large-scale investigation (Phase 3) into a new booster shot designed specifically for teenagers. The booster targets a particular variant of COVID-19, Omicron XBB.1.5.
- Trial name
- COVID-19 (NCT05973006)
- Testing
- NVX-CoV2601 co-formulated Omicron XBB.1.5 SARS-CoV-2 rS vaccine, Prototype/XBB.1.5 Bivalent Vaccine (5 µg)
- Where
- 20 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Novavax
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
Systemic Allergic Reaction
The Safety of Administering a Second Dose of a COVID-19 mRNA Vaccine in Individuals Who Experienced a Systemic Allergic Reaction to an Initial Dose
Background: Some people have allergic reactions to COVID-19 mRNA vaccines. Researchers want to learn more about these reactions to provide guidance on who can safely receive the vaccines, including a second dose in people who had…
- Trial name
- NCT04977479
- Testing
- Pfizer-BioNTech COVID-19 Vaccine (Comirnaty), Pfizer-BioNTech COVID-19 Vaccine, Bivalent
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
SARS-CoV-2
A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age
The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children as intramuscular (IM) injection in 2 doses (in Parts 1 and 2) and 3 doses (in Part 3), and a third dose or an…
- Trial name
- NCT04796896
- Testing
- mRNA-1273, mRNA-1273.214
- Where
- 91 sites in United States, Canada
- Volunteers
- 11,942 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
SARS-CoV-2
Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants
The study evaluated the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in infants aged 12 weeks to < 6 months.
- Trial name
- BabyCOVE (NCT05584202)
- Testing
- mRNA-1273.214
- Where
- 39 sites in United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Influenza, COVID-19
Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations
This is a prospective, randomized randomized immunologic study of response to influenza and SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network study sites.
- Trial name
- NCT06020118
- Testing
- Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster), Sequential Vaccination (Influenza vaccine then mRNA COVID booster), Sequential Vaccination (mRNA COVID booster then Influenza vaccine)
- Where
- 8 sites in United States
- Volunteers
- 455 people, healthy volunteers welcome
- Sponsor
- Duke University
Immunocompromised, Immunosuppressed
COVID-19 Vaccination and Breakthrough Infections Among Persons With Immunocompromising Conditions in the United States
This retrospective study will evaluate characteristics, vaccine utilization and outcomes among subjects with immunocompromising conditions that received COVID-19 vaccination.
- Conditions
- Immunocompromised, Immunosuppressed, Covid-19, SARS-COV-2
- Trial name
- NCT05020145
- Testing
- BNT162b2 (Tozinameran)
- Where
- United States
- Volunteers
- 1,277,747 people
- Sponsor
- Pfizer
Fever After Vaccination, Fever
Safety of Simultaneous mRNA COVID-19 Vaccine With Other Childhood Vaccines in Young Children
This is a prospective, randomized, open-label clinical trial to evaluate the safety of COVID-19 vaccination and other routine childhood vaccines given simultaneously at Visit 1, as compared to sequential vaccination of COVID-19…
- Conditions
- Fever After Vaccination, Fever, Seizures Fever
- Trial name
- NCT06038617
- Testing
- mRNA COVID-19 Vaccine, Routine Childhood Vaccinations
- Where
- 5 sites in United States
- Volunteers
- 347 people, healthy volunteers welcome
- Sponsor
- Duke University
Papillomavirus Infections, Coronavirus Disease (COVID-19)
Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) (COVID-19) Vaccine (V503-076)
The purpose of this study to evaluate the safety and immunogenicity of a 2-dose regimen of 9vHPV vaccine, where the first dose is administered concomitantly with a first dose of a 2-dose regimen of mRNA-1273 vaccine versus…
- Trial name
- NCT05119855
- Testing
- 9vHPV Vaccine, mRNA-1273 Vaccine
- Where
- 38 sites in United States
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
COVID-19
A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815…
- Trial name
- NextCOVE (NCT05815498)
- Testing
- mRNA-1283.222, mRNA-1273.222, mRNA-1283.815
- Where
- 230 sites in United States, Canada and 2 more
- Volunteers
- 13,553 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
SARS-CoV-2
A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19
This is a 2-part study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.529 and mRNA-1273.214 administered as a booster dose.
- Trial name
- NCT05249829
- Testing
- mRNA-1273.529, mRNA-1273, mRNA-1273.214
- Where
- 29 sites in United Kingdom
- Volunteers
- 3,548 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
SARS-CoV-2
A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19
The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection.
- Trial name
- TeenCove (NCT04649151)
- Testing
- mRNA-1273, mRNA-1273.222
- Where
- 53 sites in United States, Dominican Republic
- Volunteers
- 4,328 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
COVID-19
A Study to Understand is the COVID-19 Vaccine BNT162b2 is Safe in Indonesia People
The purpose of this study is to characterize descriptively the BNT162b2 vaccination safety experience among the Indonesian people.
- Trial name
- NCT05621239
- Testing
- BNT162b2
- Where
- Indonesia
- Volunteers
- 260 people
- Sponsor
- Pfizer
Respiratory Syncytial Virus
A Study of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in Children 2 to <18 Years of Age at High Risk of Respiratory Syncytial Virus
Part A: The purpose is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to <5 years (Cohort 1) and in children at high risk of respiratory syncytial virus (RSV) disease 5 to <18 years of…
- Trial name
- NCT06097299
- Testing
- mRNA-1345
- Where
- 50 sites in United States, Panama
- Volunteers
- 349 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.