Clinical trials: Safety and Tolerability in Healthy Volunteers
Healthy Subjects, Pneumococcal Infections
Study Evaluating Pneumococcal Vaccine in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
- Trial name
- NCT00205803
- Testing
- 13-Valent Pneumococcal Conjugate Vaccine (13vPnC), 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
- Where
- United States
- Volunteers
- 249 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy Volunteers, Propionic Acidemia
A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy Volunteers and Patients With Propionic Acidemia or Methylmalonic Acidemia
The purpose of this study is to assess the safety, tolerability, PK and PD of BBP-671 in healthy volunteers and patients with Propionic Acidemia or Methylmalonic Acidemia.
- Conditions
- Healthy Volunteers, Propionic Acidemia, Methylmalonic Acidemia, Organic Acidemia
- Trial name
- NCT04836494
- Testing
- BBP-671
- Where
- 3 sites in United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- CoA Therapeutics, Inc., a BridgeBio company
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
Safety and Tolerability in Healthy Volunteers
Safety and Tolerability Evaluation of BP-LT
This study evaluates the safety and tolerability of the food ingredient BP-LT when added to a daily diet. BP-LT is a stable protein ingredient being functional in the gastrointestinal tract and without systemic absorption.
- Trial name
- NCT07819695
- Testing
- BP-LT
- Where
- Bangladesh
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bactolife A/S
Healthy
Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine (TDV) (previously DENVax) administered subcutaneously in healthy adults and children.
- Trial name
- NCT01511250
- Testing
- TDV
- Where
- 8 sites in Colombia, Puerto Rico and 2 more
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- Takeda
Other
A Study of IW-6463 in Healthy Volunteers
Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of…
- Trial name
- NCT03856827
- Testing
- IW-6463
- Where
- Netherlands
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Tisento Therapeutics
Blister, Wound of Skin
Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa.
This is a three-part, Phase I, first-in-human study designed to evaluate the safety, tolerability, and potential systemic exposure of multiple topical doses of TCP-25.
- Conditions
- Blister, Wound of Skin, Epidermolysis Bullosa, Varicose Ulcer of Lower Limb
- Trial name
- NCT05378997
- Where
- Sweden
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Xinnate AB
Chronic Hepatitis B
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Oral HRS5091 in Healthy Subjects and Chronic Hepatitis B Patients
The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and food effect of HRS5091.
- Trial name
- NCT04480294
- Testing
- HRS5091
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Meningococcal Vaccine, rLP2086
A Trial to Assess the Safety, Tolerability and Immunogenicity of Repevax and rLP2086 Vaccine When Given Together in Healthy Subjects Aged >=11 to <19 Years.
This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how it is tolerated when given together with Repevax.
- Conditions
- Meningococcal Vaccine, rLP2086, Repevax, N Meningitidis Serogroup B
- Trial name
- NCT01323270
- Testing
- rLP2086, Repevax, Saline
- Where
- 36 sites in Finland, Germany and 1 more
- Volunteers
- 753 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pneumococcal Vaccines
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children
The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar.
- Trial name
- NCT00824655
- Testing
- 13vPnC
- Where
- 7 sites in Sweden
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- Pfizer
Meningitis, Meningococcal
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control.
- Trial name
- NCT01352793
- Testing
- rLP2086 vaccine, control
- Where
- 86 sites in United States, Australia and 10 more
- Volunteers
- 5,715 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pandemic Influenza Disease
Immunogenicity, Tolerability and Safety of One or Two Doses of an Adjuvanted Swine-origin A H1N1 Influenza Vaccine in Healthy Subjects 18 or More Years of Age Both Vaccinated and Not Yet Vaccinated Against Seasonal Influenza 2009/10
This present study, a phase II, open label study will evaluate the immunogenicity, tolerability and safety of an adjuvanted, inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in healthy subjects…
- Trial name
- NCT00992212
- Testing
- Monovalent A/H1N1 influenza vaccine
- Where
- 5 sites in Italy
- Volunteers
- 418 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Sickle Cell Disease
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.
- Trial name
- NCT06546670
- Testing
- ITU512
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteers
Safety, Tolerability, and Immunogenicity of Recombinant Meningococcal Group B Vaccine (E.Coli)
The research objective is to evaluate the safety and tolerability of the recombinant Group B meningococcal vaccine (E. coli) and explore its preliminary immunogenicity.
- Trial name
- NCT06314880
- Testing
- Recombinant Meningococcal Group B Vaccine (E. Coli) (low-dose), Recombinant Meningococcal Group B Vaccine (E. Coli) (hign-dose)
- Where
- China
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Healthy
A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001).
Epstein Barr virus (EBV) is a virus which can cause infectious mononucleosis and is associated with certain kinds of cancer and multiple sclerosis.
- Trial name
- NCT06655324
- Testing
- V350A, V350B
- Where
- 9 sites in United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Meningococcal Vaccine
A Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years
This study is to look at a new vaccine that might prevent meningococcal disease, and to look at the safety of the new vaccine as well as how well it is tolerated.
- Trial name
- NCT01299480
- Testing
- Vaccine
- Where
- 63 sites in Czechia, Denmark and 5 more
- Volunteers
- 1,714 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers.
AZD6423 SAD/MAD Study in Healthy Volunteers
This is a randomized, double-blind, placebo-controlled study of single and multiple ascending dosage levels of AZD6423 in healthy volunteers.
- Trial name
- AZD6423 (NCT01926366)
- Testing
- AZD6423
- Where
- United States
- Volunteers
- 175 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Lyme Disease
An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)
The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe.
- Trial name
- VALOR (NCT05477524)
- Testing
- VLA15, Saline
- Where
- 129 sites in United States, Canada and 5 more
- Volunteers
- 12,546 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Subjects
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Healthy Children Aged 15 Months to 17 Years
This open-label, multicenter study is designed to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal conjugate vaccine in healthy children aged more than 15 months up to less than 18 years.
- Trial name
- NCT00761631
- Testing
- 13 valent pneumococcal conjugate vaccine
- Where
- 36 sites in United States
- Volunteers
- 1,200 people
- Sponsor
- Pfizer
Meningococcal Vaccine
A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years
This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way.
- Trial name
- NCT01830855
- Testing
- rLP2086, Havrix (HAV), Saline
- Where
- 99 sites in United States, Canada and 6 more
- Volunteers
- 3,596 people, healthy volunteers welcome
- Sponsor
- Pfizer