Clinical trials: Gram-Positive Bacterial Infections
- Condition Gram-Positive Bacterial Infections
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Diphtheria, Tetanus
Safety and Immunogenicity of Hexavalent Vaccine(DTwP-HepB-IPV-Hib) in Healthy Infants
The purpose of the study is to evaluate immunogenicity and safety of three different doses of candidate hexvalent vaccine in comparison to co-administration of EupentaTM Inj.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT04073459
- Testing
- DTwP-HepB-Sabin IPV-Hib, Pentavalent vaccine and Salk IPV
- Volunteers
- 336 people, healthy volunteers welcome
- Sponsor
- LG Chem
Pneumococcal Infections
Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research \& Development Co., Ltd.
- Trial name
- NCT05092386
- Testing
- Investigational 13-valent Pneumococcal Polysaccharide Conjugate Vaccine, Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( WALVAX PCV13), Control 13-valent Pneumococcal Polysaccharide Conjugate Vaccine ( Pfizer PCV13)
- Where
- China
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sinovac Life Sciences Co., Ltd.
Botulism
BT-010 Registry for the Evaluation of Safety and Clinical Outcomes in Patients Treated With Botulinum Antitoxin
The purpose of the Registry was to evaluate patient safety following Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (BAT®) administration in adult and pediatric patients with a confirmed or suspected exposure to…
- Trial name
- NCT02055183
- Testing
- BAT
- Volunteers
- 162 people
- Sponsor
- Emergent BioSolutions
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
Infections, Streptococcal
Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged…
- Trial name
- NCT01545375
- Testing
- Pneumococcal vaccine GSK2189242A, Prevnar 13®, PedvaxHIB®
- Where
- 5 sites in United States
- Volunteers
- 1,806 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Immunogenicity and Safety of Pentaxim™ in an Indian Population
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose…
- Conditions
- Diphtheria, Tetanus, Polio, Pertussis
- Trial name
- NCT00259337
- Testing
- Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
- Where
- India
- Volunteers
- 226 people, healthy volunteers welcome
- Sponsor
- Sanofi
Diphtheria, Tetanus and Acellular Pertussis
Inter-lot Consistency Clinical Trial of Adsorbed Cell-free DTP (Three-component) Combined Vaccine
This is a randomized, blinded, peer-controlled study. There will be 3 treatment groups, screened subjects were randomized in a 1:1:1 ratio to receive three batches of the DTcP trial vaccine, and completed the primary immunization…
- Trial name
- NCT06857370
- Testing
- Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 1), Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 2), Diphtheria, Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed (DTcP Lot 3)
- Where
- China
- Volunteers
- 780 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Impetigo
Fucidin® Cream in the Treatment of Impetigo
To investigate the clinical and bacteriological efficacy of Fucidin® cream in the treatment of impetigo in paediatric patients. To assess the validity of in vitro susceptibility-testing of S.
- Trial name
- NCT00986856
- Testing
- Fucidin® cream
- Where
- 2 sites in Norway, Sweden
- Volunteers
- 58 people
- Sponsor
- LEO Pharma
Diphtheria, Tetanus
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Primary Objectives: 1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of DAPTACEL® or Pentacel™. 2.
- Conditions
- Diphtheria, Tetanus, Pertussis
- Trial name
- NCT00258895
- Testing
- DAPTACEL®: DTaP
- Where
- 22 sites in United States
- Volunteers
- 649 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Streptococcal Infections
A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine
Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.
- Trial name
- NCT00169481
- Testing
- Pneumococcal (vaccine)
- Where
- 56 sites in Germany
- Volunteers
- 689 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Tetanus
US-licensed Combined Vaccine Against Tetanus & Diphtheria, Given With US-licensed Vaccine Against Meningococcal Disease
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention…
- Conditions
- Acellular Pertussis, Tetanus, Diphtheria
- Trial name
- NCT00282295
- Testing
- Boostrix®, Menactra™
- Where
- 24 sites in United States
- Volunteers
- 1,344 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Diphtheria, Tetanus
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary…
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT00831311
- Testing
- DTaP-IPV-HB-PRP~T, DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
- Where
- Argentina
- Volunteers
- 624 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infections, Streptococcal
Primary Vaccination Course in Children Receiving the Pneumococcal Vaccine GSK 1024850A, Zilbrix™ Hib and Polio Sabin™
The purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of…
- Trial name
- NCT00678301
- Testing
- GSK Biologicals' Synflorix™, GSK Biologicals' Polio Sabin™, GSK Biologicals' Zilbrix™ Hib
- Where
- 2 sites in Mali, Nigeria
- Volunteers
- 365 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pneumococcal Infectious Disease
Clinical Trial of PCV24 in Children Aged 2-17 Years
A Phase Ia clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Sinovac Life Science Co., Ltd will be conducted in children aged 2-17 years.
- Trial name
- NCT06550830
- Testing
- Sinovac PCV24 formulation 1, Sinovac PCV24 formulation 2, Prevenar13®
- Where
- China
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Sinovac Life Sciences Co., Ltd.
Clostridium Infections, Diarrhea
PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD)
This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
- Trial name
- NCT00468728
- Testing
- PAR-101/OPT-80, Vancomycin
- Where
- 116 sites in United States, Belgium and 7 more
- Volunteers
- 535 people
- Sponsor
- Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Treponema Pallidum, Treponema Pallidum Infection
This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.
This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit.
- Conditions
- Treponema Pallidum, Treponema Pallidum Infection, Syphilis Infection, Serum
- Trial name
- NCT07089836
- Testing
- ALPCO Syphilis-T, ALPCO Syphilis-NT CLIA Kits
- Where
- 6 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- American Laboratory Products Company
Latent Tuberculosis Infection
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein
Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients.
- Trial name
- NCT05746611
- Testing
- Recombinant Mycobacterium tuberculosis fusion protein for injection, TB-PPD was injected
- Where
- China
- Volunteers
- 7,500 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Pneumococcal Infections
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)
This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age.
- Trial name
- NCT02987972
- Testing
- V114 Lot 1, V114 Lot 2, Prevnar 13™
- Where
- 49 sites in United States, Canada and 4 more
- Volunteers
- 1,051 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pneumococcal Infectious Disease
A Clinical Trial to Observe the Safety of 23-Valent Pneumococcal Polysaccharide Vaccine in Target Population
An open clinical trial of a 23-valent pneumococcal polysaccharide vaccine (PPV23) developed by Sinovac Life Science Co., Ltd was conducted to evaluate the safety of Sinovac PPV23 in target population of individuals aged 2 years…
- Trial name
- NCT07071701
- Testing
- 23-valent pneumococcal polysaccharide vaccine, Influenza vaccine
- Where
- China
- Volunteers
- 19,267 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Gram-positive Bacterial Infections
Open Label, Dose-finding, Pharmacokinetics, Safety and Tolerability Study of Oritavancin in Pediatric Participants With Suspected or Confirmed Bacterial Infections
The purpose of this Phase 1 trial is to evaluate the pharmacokinetics (PK), safety and tolerability of oritavancin in participants <18 years old with a confirmed or suspected bacterial infection.
- Trial name
- NCT02134301
- Testing
- Oritavancin
- Where
- 8 sites in United States
- Volunteers
- 41 people
- Sponsor
- Melinta Therapeutics, LLC