Clinical trials: Covid19, Vaccines
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
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
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
COVID-19 Vaccines
Improving COVID-19 Vaccine Uptake in Nursing Homes
SARS-CoV-2 vaccine, now being administered to skilled nursing facility (SNF) residents and staff, has highly variable acceptance between facilities.
- Trial name
- NCT04732819
- Testing
- High touch multi-pronged behavioral intervention
- Where
- 4 sites in United States
- Volunteers
- 23,768 people
- Sponsor
- Brown 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, COVID-19 Vaccines
Effectiveness of BNT162b2 Formulations Using State Vaccine Registry and Insurance Claims Data
The primary purpose of this study is to learn about how well different versions of the Pfizer-BioNTech COVID-19 vaccine (called BNT162b2) work at preventing death, severe COVID-19 that requires a trip to the hospital, and overall…
- Trial name
- NCT06199934
- Testing
- Vaccination
- Where
- United States
- Volunteers
- 19,853,610 people
- Sponsor
- Pfizer
COVID-19
A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELL VACCINE TRIAL
This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic hAd5-S-Fusion+N-ETSD against COVID-19.
- Trial name
- NCT06022224
- Testing
- hAd5-S-Fusion+N-ETSD
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- ImmunityBio, Inc.
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)
Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE)
COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders
This is a randomized, multi-site, adaptive, open-label clinical trial comparing the immune response to different additional doses of COVID-19 vaccine in participants with autoimmune disease requiring IS medications.
- Conditions
- Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Pemphigus Vulgaris, Multiple Sclerosis (MS)
- Trial name
- NCT05000216
- Testing
- Moderna mRNA-1273, BNT162b2, Ad26.COV2.S
- Where
- 29 sites in United States
- Volunteers
- 258 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
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.
Covid19
COVID-19 Vaccine Text Outreach
This project aims to evaluate different approaches to increase COVID-19 vaccine uptake among at-risk patients at Penn Medicine in an equitable and systematic manner through a centralized outreach program.
- Trial name
- NCT04834726
- Testing
- Opt-In (Call-Back), Opt-in (In-Bound), Standard Message
- Where
- United States
- Volunteers
- 19,554 people
- Sponsor
- University of Pennsylvania
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.
Vaccination Refusal, COVID-19
COVID-19 Vaccine Uptake Trial
The goal of this study is to assess the best COVID-19 vaccine uptake strategy among students, staff and household members that have not been vaccinated.
- Trial name
- NCT05419232
- Testing
- Short Message Service (SMS) + Website Link Strategy, Phone Call with Peer Strategy
- Where
- 8 sites in United States
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
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
Vaccine Refusal, Covid19
Project 2VIDA! COVID-19 Vaccine Intervention Delivery for Adults in Southern California
The United States (U.S.) is the country with the largest number of infections and deaths due to COVID- 19 and racial/ethnic minorities are disproportionately affected.
- Trial name
- 2VIDA! (NCT05022472)
- Testing
- COVID-19 Individual Awareness and Education., COVID-19 Community Outreach & Health Promotion., COVID-19 Individual Health Education & Linkages to Medical and Supportive Services.
- Where
- 6 sites in United States
- Volunteers
- 1,051 people, healthy volunteers welcome
- Sponsor
- Britt Skaathun
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