Clinical trials: Central Nervous System Bacterial Infections
Meningococcal Disease, Meningococcal Meningitis
A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea
This study is designed to evaluate the immunogenicity and the safety of a quadrivalent vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.
- Trial name
- NCT01274897
- Testing
- Novartis MenACWY-CRM
- Where
- 8 sites in South Korea
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Disease, Meningococcal Meningitis
Safety and Immunogenicity of Novartis Meningococcal B Vaccine Formulated With OMV Manufactured at Two Different Sites, in Healthy Adolescents Aged 11-17 Years
The primary objective of this study is to demonstrate the equivalence of rMenB+OMV NZ lot 1 to rMenB+OMV NZ lot 2 when administered to adolescents, as measured by human serum bactericidal activity (hSBA) geometric mean titers…
- Trial name
- NCT01423084
- Testing
- Serogroup B meningococcal vaccine
- Where
- 13 sites in Australia, Canada
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- Novartis
Meningococcal Infections, Meningococcal Meningitis
Exploratory Trial to Evaluate the Safety and Immunogenicity of Menactra® and Menomune® Vaccines in Subjects ≥ 56 Years
Safety: To describe the rates of immediate reactions, solicited injection-site and systemic reactions, all unsolicited adverse events, and serious adverse events following vaccination with either Menactra® vaccine or Menomune®…
- Trial name
- NCT00874549
- Testing
- Menomune®: A, C, Y, W-135 Meningococcal Polysaccharide, Menactra®: Polysaccharide Diphtheria Toxoid Conjugate
- Where
- 6 sites in United States
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningitis, Meningococcal Meningitis
Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam
The aim of the study is to assess the safety of Menactra vaccine in infants, toddlers, children, adolescents, and adults Objective: To describe the safety profile after each and any dose (when applicable) of Menactra vaccine in…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02640404
- Testing
- Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- Vietnam
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Infections
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe
Primary objective: This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared…
- Trial name
- NCT03547271
- Testing
- MenACYW conjugate vaccine, Meningococcal group A, C, W-135, and Y conjugate vaccine, DTaP-IPV-HB-Hib vaccine
- Where
- 33 sites in Czechia, Finland and 5 more
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infections, Meningococcal
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine With or Without Co-administration of Cervarix and Boostrix in Female Adolescents and Young Adults
The purpose of this study is to evaluate safety and immunogenicity of GSK Biologicals' meningococcal vaccine GSK134612 (MenACWY-TT) co-administered with Cervarix as compared to MenACWY-TT and Cervarix administered alone and the…
- Trial name
- NCT01755689
- Testing
- Meningococcal vaccine GSK134612, Cervarix®, Boostrix®
- Where
- 3 sites in Dominican Republic, Estonia and 1 more
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Poliomyelitis
Immunogenicity and Safety of Booster Dose of BoostrixTM Polio Vaccine in Previously Boosted Adults
This study will evaluate the persistence of immune response against diphtheria, tetanus, pertussis and poliomyelitis in healthy adults, 10 years after a booster dose, and also assess the immunogenicity and safety of another…
- Conditions
- Acellular Pertussis, Poliomyelitis, Diphtheria, Tetanus
- Trial name
- NCT01323959
- Testing
- BoostrixTM Polio
- Where
- 15 sites in France, Germany
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Poliomyelitis, Tetanus
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Diphtheria
- Trial name
- NCT01309646
- Testing
- Infanrix™-IPV+Hib, Infanrix™ IPV, Hiberix™
- Where
- 11 sites in South Korea
- Volunteers
- 454 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Poliomyelitis
Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)
This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4…
- Conditions
- Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b
- Trial name
- NCT01248884
- Testing
- Infanrix hexa™, Prevenar 13®, GSK217744
- Where
- 16 sites in Dominican Republic, Finland
- Volunteers
- 721 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bacterial Infections, Virus Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine.
- Trial name
- NCT01341639
- Testing
- V419, INFANRIX™ hexa, RotaTeq
- Volunteers
- 1,250 people, healthy volunteers welcome
- Sponsor
- MCM Vaccines B.V.
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
Poliomyelitis, Diphtheria
Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine
Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety…
- Conditions
- Poliomyelitis, Diphtheria, Tetanus, Acellular Pertussis
- Trial name
- NCT00635128
- Testing
- Boostrix-Polio
- Where
- 38 sites in Germany
- Volunteers
- 415 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Meningitis
A Phase 4, Placebo-Controlled, Randomized Study to Evaluate the Immunogenicity and Safety of HPV and Tdap When Administered With MenACWY in Adolescents
The main objective is to determine whether immune responses to Tdap (GlaxoSmithKline, Boostrix®) and HPV vaccine (Merck \& Co., Inc., Gardasil®) when administered concomitantly with MenACWY are comparable to responses elicited by…
- Trial name
- NCT01424644
- Testing
- MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine
- Where
- 20 sites in United States, Italy
- Volunteers
- 801 people, healthy volunteers welcome
- Sponsor
- Novartis
Cryptococcal Meningitis, Fungal Meningitis
Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis
This is a phase III trial to determine whether adjunctive sertraline will lead to improved survival 18-week survival. There was an initial phase I/II unmasked dose finding pharmacokinetic study of CSF concentrations in 172…
- Trial name
- ASTRO-CM (NCT01802385)
- Testing
- Sertraline
- Where
- 2 sites in Uganda
- Volunteers
- 460 people
- Sponsor
- University of Minnesota
Chronic Fatigue Syndrome
Myalgic Encephalomyelitis Chronic Fatigue at the National Institutes of Health
Background: Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS) refers to long-lasting and disabling fatigue or malaise, inability to recover after exercise, and physical and emotional discomfort that…
- Trial name
- NCT02669212
- Testing
- Cardiopulmonary Exercise Test (CPET)
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Meningococcal Infection, Meningitis
A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration.
- Trial name
- NCT01086969
- Testing
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)
- Where
- 3 sites in India
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Sanofi
Pertussis, Diphtheria
Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine
Post-marketing evaluation of reactions following receipt of recommended adolescent pertussis vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine.
- Conditions
- Pertussis, Diphtheria, Tetanus, Poliomyelitis
- Trial name
- NCT00304265
- Testing
- COVAXIS™: Tetanus, diphtheria, acellular 5-component pertussis, or + inactivated poliovirus vaccine (REPEVAX®)
- Where
- 17 sites in Germany
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Hepatitis B, Polio
Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00362336
- Testing
- DTaP-IPV-HB-PRP~T, CombAct-HIB®, Engerix B® Pediatric
- Where
- 2 sites in South Africa
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants
The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01177722
- Testing
- DTaP-IPV-Hep B-PRP-T Vaccine, DTaP-Hep B-IPV vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,375 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Meningitis, Measles
A Study of 2 Doses of Menactra®, a Meningococcal Conjugate Vaccine in Healthy Toddlers
This is a Phase III, modified single-blind, randomized, parallel-group, multicenter, comparative trial in the United States designed to evaluate the immunogenicity and safety of two doses of Menactra vaccine administered alone…
- Conditions
- Meningococcal Meningitis, Measles, Mumps, Rubella
- Trial name
- NCT00384397
- Testing
- Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine, Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
- Where
- 39 sites in United States
- Volunteers
- 1,128 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company