Clinical trials: Central Nervous System Bacterial Infections
Meningococcal Disease
Safety and Immunogenicity Study of Two Doses of Novartis Meningococcal Serogroup B Recombinant Vaccine in Adolescents Aged 11-17 Years.
The purpose of the study was to assess the immunogenicity and safety of two doses of Novartis Meningococcal B Recombinant (rMenB+OMV NZ) vaccine administered one month apart (0, 1 month schedule) in Korean adolescents aged…
- Trial name
- NCT01973218
- Testing
- Meningococcal B Recombinant vaccine rMenB+OMV NZ, Meningococcal ACWY-CRM conjugate vaccine
- Where
- 7 sites in South Korea
- Volunteers
- 264 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningitis, Meningococcal, Rotavirus Infections
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Primary objective: To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine.
- Trial name
- NCT00443846
- Testing
- RotaTeq®, NeisVac-C®
- Volunteers
- 247 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Diphtheria, Tetanus
Study of DAPTACEL® Administered as a 5th Dose in 4 to 6-Year-Old Children Previously Immunized With PENTACEL™
Objectives: To present the rates of adverse reactions after a dose of DAPTACEL® vaccine administered to children 4 to 6 years of age who have previously received four doses of PENTACEL™ vaccine.
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio
- Trial name
- NCT00802867
- Testing
- Diphtheria and Tetanus Toxoids and Acellular Pertussis (DAPTACEL®)
- Where
- 19 sites in United States
- Volunteers
- 989 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Regulatory Post-Marketing Surveillance Study for TETRAXIM™
The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis
- Trial name
- NCT01437423
- Testing
- TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio
- Where
- South Korea
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Bacterial Meningitis
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 75 Years of Age in India
This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.
- Trial name
- NCT01547715
- Testing
- Meningococcal ACWY conjugate vaccine
- Where
- 4 sites in India
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Novartis
Meningitis, Meningococcal, Serogroup B
Safety and Blood Donations in Adults Vaccinated With rMenB+OMV NZ.
The purpose of this trial is to assess the safety of a Meningococcal Group B Vaccine and to collect blood donation. Sera panel obtained from blood donations will be used as a control to measure the immunoresponse to the…
- Trial name
- NCT02305446
- Testing
- Meningococcal (group B) multicomponent recombinant adsorbed vaccine
- Where
- Poland
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Novartis
Meningococcal Disease, Meningococcal Meningitis
Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12
This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two…
- Trial name
- NCT00944034
- Testing
- rMenB+OMV NZ with routine vaccinations, rMenB+OMV NZ, two doses of rMenB+OMV NZ
- Where
- 72 sites in Belgium, Czechia and 4 more
- Volunteers
- 1,588 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Tetanus, Diphtheria
Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
The study was designed to compare the safety and immunogenicity of DTap-IPV with DAPTACEL® + IPOL® as the 5th dose booster in children ≥ 4 to < 7 years of age in the US and Puerto Rico who were previously vaccinated with…
- Conditions
- Tetanus, Diphtheria, Pertussis, Measles
- Trial name
- NCT01346293
- Testing
- Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus, Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus
- Where
- 72 sites in United States, Puerto Rico
- Volunteers
- 3,372 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningoccocal Disease, Meningococcal Meningitis
Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28
The aim of this extension study is to explore the antibody persistence 24 to 36 months after the last dose of vaccine, in infants that received a two or three dose primary series plus a booster dose at 11 months of age, of the…
- Trial name
- NCT01894919
- Testing
- Bexsero® vaccine (1 dose at study month zero), Bexsero® vaccine (2 doses 1 month apart)
- Where
- 17 sites in Hungary, Spain
- Volunteers
- 851 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningitis, Meningococcal Meningitis
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adolescents
The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed vaccine MENVEO® in…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02199691
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 1,715 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Cryptococcal Meningitis
Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis
Cryptococcal meningitis (CM) is a fungal infection that causes a severe syndrome of meningitis that is 100% fatal without antifungal therapy.
- Trial name
- NCT06414512
- Testing
- AMBITION trial control, Flucytosine
- Where
- 2 sites in Uganda
- Volunteers
- 48 people
- Sponsor
- University of Minnesota
Tetanus, Hepatitis B
Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083 vaccine co-administered with Prevenar 13® at 2, 4 and 12 months of age and with Rotarix™ at 2 and 4 months of age.
- Conditions
- Tetanus, Hepatitis B, Haemophilus Influenzae Type b, Poliomyelitis
- Trial name
- NCT01090453
- Testing
- GSK2202083A vaccine, Prevenar 13®, Infanrix hexa™
- Where
- 34 sites in Canada, France and 1 more
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningitis, Meningococcal Meningitis
Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
The purpose of the study was to evaluate immune lot consistency of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine and the immune non-inferiority compared to the licensed vaccine…
- Conditions
- Meningitis, Meningococcal Meningitis, Meningococcal Infections
- Trial name
- NCT02842853
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- 89 sites in United States
- Volunteers
- 3,344 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
To assess the safety and reactogenicity of the DTPa-IPV/Hib vaccine as primary and booster vaccination. The DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK Biologicals' rotavirus vaccine or…
- Conditions
- Diphtheria, Tetanus, Poliomyelitis, Acellular Pertussis
- Trial name
- NCT00325156
- Testing
- GSK Biologicals' combined DTPa-IPV/Hib vaccine
- Where
- Singapore
- Volunteers
- 2,590 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease, Meningococcal Meningitis
Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10
This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713).
- Trial name
- NCT01148524
- Testing
- No Vaccine, rMenB+OMV-NZ
- Where
- 6 sites in Chile
- Volunteers
- 817 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Poliomyelitis, Tetanus
Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine
This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT01353703
- Testing
- Infanrix hexa™
- Where
- 4 sites in India
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bacterial Meningitis
Slow Initial β-lactam Infusion With High-dose Paracetamol to Improve the Outcomes of Childhood Bacterial Meningitis
The main purpose of this trial is to test if mortality of childhood bacterial meningitis can be reduced by slow, continuous infusion of cefotaxime initially, instead of the traditional bolus administration four times daily (qid)…
- Trial name
- INFU/PARA (NCT01540838)
- Testing
- Infusion with paracetamol, Bolus without paracetamol
- Where
- Angola
- Volunteers
- 375 people
- Sponsor
- University of Helsinki
Infections, Meningococcal
Study to Assess the Immunological Long-term Persistence of Antibodies (Abs) 2 Years After GlaxoSmithKline (GSK) Meningococcal ABCWY Vaccination in the V102_15 (NCT02212457) and Response to a Booster in Adolescents
The purpose of this study is to compare the persistence of 2 or 3 doses of the GSK MenABCWY vaccine, or 2 doses of GSK rMenB+OMV vaccine (Bexsero) administered to healthy adolescents at approximately 24 months after the last…
- Trial name
- NCT02946385
- Testing
- Meningococcal ABCWY Vaccine, Meningococcal B Recombinant vaccine
- Where
- 17 sites in Finland, Poland
- Volunteers
- 604 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Meningitis, Tetanus
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine.
- Conditions
- Meningococcal Meningitis, Tetanus, Diphtheria, Pertussis
- Trial name
- NCT00355121
- Testing
- Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Where
- 26 sites in United States
- Volunteers
- 882 people, healthy volunteers welcome
- Sponsor
- Sanofi
Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children
Evaluate the persistency of immune response against Haemophilus influenzae type b by assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT booster vaccine approximately 4 years before.
- Trial name
- NCT02139228
- Testing
- Hib-CRM197, Hib-TT
- Where
- China
- Volunteers
- 426 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines