Clinical trials: Gram-Positive Bacterial Infections
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
Tuberculosis
Evaluation of Safety, Immunogenicity, and Prevention of TB With AERAS-404 and BCG Revaccination in Healthy Adolescents
Randomized, Placebo Controlled, Partially Blinded Phase II Study to Evaluate Safety, Immunogenicity, and Prevention of Infection with Mycobacterium tuberculosis of AERAS-404 and BCG Revaccination in Healthy Adolescents
- Trial name
- NCT02075203
- Testing
- AERAS-404, Bacillus Calmette-Guérin (BCG)
- Where
- 2 sites in South Africa
- Volunteers
- 989 people, healthy volunteers welcome
- Sponsor
- Aeras
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
Pneumococcal Infections
Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)
The purpose of this study is to 1) evaluate the safety and tolerability of V114 and 2) to compare the immune responses of the 15 serotypes contained in V114 with V114 versus Prevnar 13™.
- Trial name
- PNEU-AGE (NCT03950622)
- Testing
- V114, Prevnar 13®
- Where
- 30 sites in United States, Canada and 3 more
- Volunteers
- 1,205 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
C. Diff. Infections
Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.
- Trial name
- NCT04893239
- Testing
- LMN-201 Anti-toxin B VHH-1, LMN-201 Anti-toxin B VHH-2, LMN-201 Anti-toxin B VHH-3
- Where
- 3 sites in Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Lumen Bioscience, Inc.
Pneumococcal Disease
Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults 50 Years of Age or Older (V116-010, STRIDE-10)
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age and older.
- Trial name
- NCT05569954
- Testing
- V116, PPSV23
- Where
- 55 sites in Argentina, Australia and 9 more
- Volunteers
- 1,484 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
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
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
Infections, Streptococcal, Streptococcal Infections
Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to 40 years of age the safety and immunogenicity of a liquid formulation of Group B Streptococcus (GBS) Trivalent Vaccine (not requiring…
- Trial name
- NCT02270944
- Testing
- GBS Vaccine
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 1,053 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
Anthrax
Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)
The purpose of this study is to: evaluate the safety profile of a single intravenous administration of AIGIV (containing either 3.5 mg/kg, 7.0 mg/kg or 14.0 mg/kg anti-PA IgG) as compared with either 90 mg/kg, 180 mg/kg or 360…
- Trial name
- NCT00845650
- Testing
- AIGIV 3.5 mg/kg, Gamunex 90 mg/kg, AIGIV 7.0 mg/kg
- Where
- United States
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Streptococcal Infection, Gram-positive Bacterial Infection
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.
- Conditions
- Streptococcal Infection, Gram-positive Bacterial Infection, Bacterial Infection
- Trial name
- NCT01446289
- Testing
- Group B Streptococcus Trivalent Vaccine
- Where
- 5 sites in Belgium, Canada
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Novartis
Pneumococcal Disease
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
The purpose of this study is to describe the safety of the study vaccine (called 13vPnC) in people who are 18-49 years of age in India.
- Trial name
- NCT05329259
- Testing
- 13-valent pneumococcal conjugate vaccine
- Where
- 5 sites in India
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pneumococcal Disease
Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.
- Trial name
- NCT05489328
- Testing
- Candidate-1, Candidate-2, Candidate-3
- Where
- 18 sites in United States
- Volunteers
- 394 people, healthy volunteers welcome
- Sponsor
- Pfizer
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
Tuberculosis
Study of AERAS-402 in Healthy Infants
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
- Trial name
- NCT01198366
- Testing
- AERAS-402 1.5 x 10^10 vp, AERAS-402 3.0 x 10^10 vp, AERAS-402 1.0 x 10^11 vp
- Where
- 7 sites in Kenya, Mozambique and 1 more
- Volunteers
- 487 people, healthy volunteers welcome
- Sponsor
- Aeras
Pneumococcal Infections
Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
This study will evaluate the safety, tolerability and immunogenicity of study vaccines 13vPnC and 23vPS in older, healthy subjects who have previously received a dose of 23vPS at least 5 years ago.
- Trial name
- NCT00546572
- Testing
- 13 valent Pneumococcal Conjugate Vaccine, 23vPS
- Where
- 58 sites in United States, Sweden
- Volunteers
- 938 people, healthy volunteers welcome
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Diphtheria, Tetanus
Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children
This study will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old…
- Conditions
- Diphtheria, Tetanus, Acellular Pertussis
- Trial name
- NCT01988857
- Testing
- Boostrix™
- Where
- Vietnam
- Volunteers
- 302 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either…
- Trial name
- NCT00370396
- Testing
- Synflorix, Prevenar, Infanrix hexa
- Where
- 35 sites in Finland, France and 1 more
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline