Clinical trials: Humans
Healthy Adult Subjects
A Study to Investigate the PK, Safety, and Tolerability Between AVT05, US and EU Simponi® in Healthy Adult Participants
Rationale: Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05.
- Trial name
- NCT05632211
- Testing
- AVT05, Simponi
- Where
- 2 sites in New Zealand, United Kingdom
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Hemorrhagic Fever, Ebola
Long-term Safety Follow-up of Participants Exposed to the Candidate Ebola Vaccines Ad26.ZEBOV and/or MVA-BN-Filo
The purpose of the study is to assess the long-term safety profile of Ad26.ZEBOV and MVA-BN-Filo in participants previously exposed to these vaccines in Phase 1, 2, or 3 clinical studies.
- Trial name
- NCT02661464
- Testing
- Ad26.ZEBOV, MVA-BN-Filo
- Where
- 16 sites in United States, Burkina Faso and 5 more
- Volunteers
- 677 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Nicotine Dependence, Nicotine Withdrawal
Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence
The objective of this proposal is to elucidate effects of bupropion SR + varenicline on smoking-cessation related processes in early abstinence using a human laboratory model.
- Trial name
- ChanBan (NCT00749658)
- Testing
- Bupropion, Varenicline
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Anti-Hepatitis A Antibody Levels in Heathy Subjects
Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)
This was a single center, open-label, single-arm study in which approximately 28 Hepatitis A virus (HAV)-seronegative healthy subjects were enrolled.
- Trial name
- GamaSTAN (NCT03351933)
- Testing
- Immune Globulin (Human)
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Grifols Therapeutics LLC
Severe Acute Respiratory Syndrome, Coronavirus
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19
This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of CVnCoV at different dose levels.
- Conditions
- Severe Acute Respiratory Syndrome, Coronavirus, SARS-CoV-2, COVID-19
- Trial name
- NCT04449276
- Testing
- CVnCoV Vaccine
- Where
- 4 sites in Belgium, Germany
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- CureVac
Influenza
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 4, 2012
This study will investigate markers, mechanisms and define general predictors for immunological health by comparing influenza vaccine responses in monozygotic and dizygotic twins.
- Trial name
- NCT03022435
- Testing
- TIV, High-Dose TIV, LAIV
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Stanford University
SARS-CoV-2, Influenza
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.
- Trial name
- NCT05375838
- Testing
- mRNA-1073, mRNA-1010, mRNA-1273
- Where
- 14 sites in United States
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Influenza, Pandemic
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults
The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014. BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu.
- Trial name
- IN-NE-rH5 (NCT05397119)
- Testing
- BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN, BW-1014: 100 µg rH5 in 20% NE - pipette - IN
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- BlueWillow Biologics
Influenza
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine, Fluarix/Influsplit Tetra® (2013/2014 Season), in Adults 18 Years of Age and Older
The purpose of this study is to assess, in adults 18 years of age and above, the immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit Tetra containing the four influenza strains (two A strains…
- Trial name
- NCT01878812
- Testing
- Fluarix/Influsplit Tetra® (2013-2014 season)
- Where
- 4 sites in Germany
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infections, Sexually Transmitted Diseases
Evaluation of Many Men, Many Voices, An STD/HIV Prevention Intervention for Black MSM
The purpose of this program evaluation is to determine whether the "Many Men, Many Voices" HIV/STD prevention intervention is effective in reducing HIV sex risk behaviors and increasing HIV testing among African-American men who…
- Trial name
- 3MV (NCT00137631)
- Testing
- Many Men, Many Voices (3MV)
- Where
- United States
- Volunteers
- 341 people, healthy volunteers welcome
- Sponsor
- Centers for Disease Control and Prevention
Influenza, Human
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
This Phase 3 study is a randomized, observer-blind immunogenicity and safety study of aQIV (an MF59-adjuvanted quadrivalent influenza vaccine) compared with a licensed quadrivalent influenza vaccine in adults 50 to 64 years of…
- Trial name
- NCT05044195
- Testing
- aQIV, Comparator QIV
- Where
- 29 sites in United States, Estonia and 1 more
- Volunteers
- 2,044 people, healthy volunteers welcome
- Sponsor
- Seqirus
Influenza
Safety and Reactogenicity of FluBlok and Comparison of Immunogenicity, Efficacy and Effectiveness Against TIV
The purpose of this study was to evaluate and compare the safety, reactogenicity, immunogenicity, relative efficacy and effectiveness of FluBlok to a licensed trivalent influenza vaccine (TIV)in healthy adults age 50-64 years.
- Trial name
- NCT00539864
- Testing
- FluBlok Influenza Vaccination, TIV (Fluzone) Influenza Vaccination
- Where
- 5 sites in United States
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- Protein Sciences Corporation
Healthy
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
The study purpose is to evaluate the potential for a pharmacokinetic drug-drug interaction, safety and tolerability when Narlaprevir, Ritonavir (used as a metabolic inhibitor) and Tenofovir disoproxil fumarate (part 1) and…
- Trial name
- NCT03537404
- Testing
- Narlaprevir, Ritonavir, Tenofovir Disoproxil Fumarate
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- R-Pharm
Immune Response
Immune Responses Induced by Different Licensed Influenza Vaccines
The goal of this research is to find out how the body's immune system responds to different manufacturer's "flu" vaccines.
- Trial name
- NCT00902278
- Testing
- Flulaval, Fluvirin, Fluzone
- Where
- United States
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- University of Massachusetts, Worcester
Tetanus, Poliomyelitis
Study to Evaluate Antibody Persistence in Children Previously Vaccinated With Infanrix Hexa™ or Infanrix-IPV/Hib™
The aim of this study is to assess antibody persistence in infants who received three doses of Infanrix hexa™ (DTPa-HBV-IPV/Hib) or Infanrix-IPV/Hib™ (DTPa-IPV/Hib) at 3, 5 and 11 months of age in study NCT00307034.
- Conditions
- Tetanus, Poliomyelitis, Haemophilus Influenzae Type b, Acellular Pertussis
- Trial name
- NCT01358825
- Testing
- Blood Sampling
- Where
- 4 sites in Norway, Sweden
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Avian Influenza, H1N1 Influenza
H7N9 Vaccination With and Without AS03 and Unadjuvanted H3N2v Vaccination: Standard and Systems Biology Analyses
This is a single center, randomized, partially-blinded, Phase II, small, targeted, prospective study in approximately 30 healthy male and non-pregnant female subjects aged 18 to 49 years old, inclusive, designed to evaluate and…
- Conditions
- Avian Influenza, H1N1 Influenza, Influenza
- Trial name
- NCT02921997
- Testing
- AS03, Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203, Monovalent influenza A/H7N9 virus vaccine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Type 1 Diabetes
Measurement of Glucose/Glycogen Metabolism in Humans Using Magnetic Resonance at 4 or 7 Tesla
The long-range goal of this project is to determine the effects of diabetes and the hypoglycemic consequences of intensive therapy on in vivo brain glucose metabolism in humans.
- Trial name
- Glycogen (NCT00786825)
- Testing
- somatostatin
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Healthy
Assessing Choice in the Employer Setting (ACES) Study
The purpose of this study is to determine, among adults and in the total population, the effects of offering a choice of FluMist or trivalent inactivated vaccine (TIV) in the employer setting when compared to a control group.
- Trial name
- MA181 (NCT00808808)
- Testing
- Choice of TIV or FluMist with baseline advertisement, Choice of TIV or FluMist with enhanced advertisement and incentives, Control - Usual care offering TIV only with baseline advertisement
- Where
- 47 sites in United States
- Volunteers
- 4,411 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Infections, Papillomavirus
Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects
Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV…
- Trial name
- NCT00947115
- Testing
- Blood sampling, Cervico-vaginal secretion (CVS) samples
- Where
- 6 sites in Germany, Poland
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Streptococcus Pneumonia, Controlled Human Infection
Experimental Human Pneumococcal Challenge With SPN3
The 'Experimental Human Pneumococcal challenge' (EHPC) model is a way of putting drops of bacteria into the nose. Investigators have studied this model of putting bacteria in the nose safely in over 1500 volunteers over the past…
- Trial name
- Challenge3 (NCT05535868)
- Testing
- Serotype 3 Experimental Human Pneumococcal Challenge - Liverpool Isolate (LIV014-S3), Serotype 3 Experimental Human Pneumococcal Challenge - Malawi Isolate (MLW-10V)
- Where
- United Kingdom
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
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