Clinical trials: Phase III
Serogroup B Meningococcal Meningitis
Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
The proposed study was aimed to assess the immunogenicity, safety, tolerability and lot to lot consistency of 3 lots of Novartis Meningococcal B vaccine when given concomitantly with routine infant vaccines.
- Trial name
- NCT00657709
- Testing
- Serogroup B meningococcal Vaccine lot 1 (rMenB Lot 1), Serogroup B meningococcal Vaccine lot 2 (rMenB Lot 2), Serogroup B meningococcal Vaccine lot 3 (rMenB Lot 3)
- Where
- 66 sites in Austria, Czechia and 3 more
- Volunteers
- 3,630 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Pertussis
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines
OBJECTIVES: I. Compare the efficacy of 2 acellular pertussis vaccines vs. whole-cell pertussis vaccine vs. placebo in infants living in Italy. II. Compare the relative protection of each of the acellular vaccines vs.
- Trial name
- NCT00004800
- Testing
- diphtheria-tetanus-pertussis vaccine containing whole-cell pertussis, diphtheria-tetanus vaccine
- Volunteers
- 13,250 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Vaccination
Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Have to be Vaccinated MenBVac®
The main objective of the study is to estimate the proportion of children, born between the 06/04/2004 and the 17/004/2008, living around Neufchatel en Bray, vaccinated by MenBVac, with a serum bactericidal activity against…
- Trial name
- EFFIVAC (NCT01054053)
- Testing
- MenBVac Vaccination
- Where
- France
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- University Hospital, Rouen
Neisseria Meningitidis, Bacterial Infections
Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination
Primary Series Primary objectives To demonstrate that the concomitant administration of the hexavalent vaccine with a meningococcal serogroup C conjugate vaccine is non inferior to the administration of the hexavalent vaccine…
- Conditions
- Neisseria Meningitidis, Bacterial Infections, Virus Diseases
- Trial name
- NCT01839175
- Testing
- Hexavalent vaccine, NeisVac-C, Prevenar 13
- Where
- 11 sites in Finland
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Japanese Encephalitis
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
The purpose of this study is to determine non-inferiority in seroconversion and to compare the safety and tolerability between ChimeriVaxTM-JE and JE-VAX to the respective homologous virus strain after completion of vaccination…
- Trial name
- NCT00314145
- Testing
- ChimeriVax™-JE, JE-VAX®
- Where
- 10 sites in United States, Australia
- Volunteers
- 820 people, healthy volunteers welcome
- Sponsor
- Sanofi
Chronic Periodontitis
The Effect of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients
To evaluate the effect of systemic administration of zinc on the gingival crevicular fluid level of total oxidant capacity in controlled Type-2 diabetic patients with stage-II and III periodontitis after non-surgical periodontal…
- Trial name
- NCT03923829
- Testing
- Zinc Sulfate, scaling and root planing
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Cairo University
Healthy Volunteers
A Study to Assess Bioavailability & Food Effect of Different Liquid and Capsule Formulations of TMC435.
The purpose of this study is to evaluate the relative bioavailability and the short-term safety and tolerability of TMC435 following administration of 3 single oral doses of 150 mg, given as different formulations in healthy…
- Trial name
- NCT01571570
- Testing
- TMC435 150 mg capsule, TMC435 150 mg oral suspension (20 mg/mL), TMC435 150 mg oral solution (10 mg/mL)
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Janssen R&D Ireland
Tick-Borne Encephalitis
Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and Older
The main purpose of this study is to provide safety and immunogenicity data in Japanese participants.
- Trial name
- NCT04648241
- Testing
- TBE vaccine 0.5 mL, TBE vaccine 0.25 mL
- Where
- 6 sites in Japan
- Volunteers
- 165 people, healthy volunteers welcome
- Sponsor
- Pfizer
Gynecological Laparoscopy
Pain Relief by Intra-Peritoneal Nebulization of Ropivacaine Under Remifentanil Anesthesia for Gynecological Laparoscopy
In our prospective, randomized, placebo controlled and double-blinded study we will study the efficacy of intraperitoneal ropivacaine nebulization on pain relief during gynecologic laparoscopic surgery.
- Trial name
- PSDR (NCT00927979)
- Testing
- 10 mLRopivacaine 1%, Water for injection, 10 mL Ropivacaine 1%
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Carmel Medical Center
Bladder Cancer, Kidney Cancer
Biomarkers in Patients With Kidney Cancer or Cancer of the Urothelium and in Healthy Participants
RATIONALE: Studying samples of blood and urine from patients with cancer and from healthy participants in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
- Conditions
- Bladder Cancer, Kidney Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
- Trial name
- NCT00900276
- Testing
- immunologic technique, laboratory biomarker analysis, mass spectrometry
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
RSV Immunisation
Efficacy, Immunogenicity, and Safety Study of a Respiratory Syncytial Virus Vaccine in Infants and Toddlers
This study is a phase III, randomized, observer-blind, placebo-controlled, multinational, multi-center study to be conducted in approximately 6300 children 6 months to < 22 months of age.
- Trial name
- PEARL (NCT06252285)
- Testing
- RSVt Vaccine
- Where
- 130 sites in United States, Argentina and 14 more
- Volunteers
- 6,300 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Upper Respiratory Tract Infection
Montelukast as Prophylaxis for Upper Respiratory Tract Infections in Children: a Randomised, Double-blind, Placebo-controlled Study
Viral upper respiratory tract infection (URI) is one of the most common diseases among toddlers and pre-school children.Complete and effective prevention measures for URI are currently unavailable.
- Trial name
- NCT00551382
- Testing
- Muntelukast
- Where
- 3 sites in Israel
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Assaf-Harofeh Medical Center
Contraception, Women at Risk for Pregnancy
Evaluation of the Efficacy, Safety, and Tolerability of LevoCept
To assess the contraceptive efficacy (prevention of pregnancy) of LevoCept
- Trial name
- NCT04457076
- Testing
- LevoCept
- Where
- 27 sites in United States
- Volunteers
- 1,525 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
Respiratory Syncytial Viruses, Respiratory Syncytial Virus Infections
A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults
To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged >=50 years of age.
- Trial name
- RSV-OA=ADJ-020 (NCT05966090)
- Testing
- RSVPreF3 OA investigational vaccine, HZ/su vaccine
- Where
- 31 sites in United States, Canada
- Volunteers
- 530 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents
The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years.
- Trial name
- NCT00645411
- Testing
- Cell culture-derived influenza subunit vaccine (cTIV), Egg derived influenza subunit vaccine (eTIV)
- Where
- 60 sites in United States, Croatia and 5 more
- Volunteers
- 3,604 people, healthy volunteers welcome
- Sponsor
- Novartis
Device - Intubating Laryngeal Airway
Evaluation of the Intubating Laryngeal Airway in Children
The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically engineered for use both as a standalone laryngeal mask airway (LMA) and as a rescue device or "Plan B" device in the event of a difficult…
- Trial name
- NCT01233011
- Where
- Canada
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- University of British Columbia
Respiratory Syncytial Virus (RSV)
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of RSVpreF in children 5 to <18 years of age at high risk for RSV disease, including those who are immunocompromised.
- Trial name
- NCT07839871
- Testing
- RSVpreF
- Where
- 2 sites in United States, Japan
- Volunteers
- 920 people, healthy volunteers welcome
- Sponsor
- Pfizer
HIV Infections
Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
This study will evaluate the safety and efficacy of the long-acting injectable agent cabotegravir (CAB LA) compared to daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for pre-exposure prophylaxis (PrEP) in…
- Trial name
- NCT03164564
- Testing
- Oral CAB, Oral TDF/FTC, CAB LA
- Where
- 20 sites in Botswana, Eswatini and 5 more
- Volunteers
- 3,224 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Photoaging, Actinic Keratosis
5fluorouracil for Advanced Photoaging
It is well known the efficacy of 5% 5-fluoruracil for multiple and superficial actinic keratosis (AKs)treatment. Recently its additional benefit for advanced and severe photoaging while treating Aks was reported.
- Trial name
- NCT01405144
- Testing
- 5-fluoruracil
- Where
- Brazil
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Federal University of São Paulo
Meningococcal Infections
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
- Trial name
- NCT00616421
- Testing
- MenACWY-CRM, Licensed meningococcal ACWY vaccine
- Where
- 68 sites in United States, Canada
- Volunteers
- 2,907 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
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