Clinical trials: Bacterial Co-infection
Infections, Streptococcal
A Study to Compare the Immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose Presentation to the Licensed 1-dose Synflorix™ (10Pn-PD-DiT) Vaccine When Co-administered With DTPw-combination Vaccine in Healthy Infants
The primary aim of the study is to demonstrate that an investigational 4-dose presentation of the 10Pn-PD-DiT vaccine with preservative is non-inferior to the licensed presentation of Synflorix (preservative-free) in terms of…
- Trial name
- NCT02447432
- Testing
- Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation), Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation), DTPw-HBV/Hib
- Where
- Bangladesh
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Evaluate Safety and Immunogenicity of a Booster Dose of Pneumococcal Conjugate Vaccine in Preterm Born Infants.
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals´ pneumococcal conjugate vaccine co-administered with a booster dose of DTPa-IPV/Hib…
- Trial name
- NCT00609492
- Testing
- GSK Biologicals´ Pneumococcal Conjugate Vaccine (GSK1024850A), Infanrix™-IPV/Hib
- Where
- 7 sites in Greece, Spain
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tuberculosis, Pulmonary Tuberculosis
Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
The METHOD study will examine whether adding metformin to standard antibiotic treatment for tuberculosis (TB) in people with HIV is safe and well tolerated.
- Conditions
- Tuberculosis, Pulmonary Tuberculosis, HIV Coinfection
- Trial name
- METHOD (NCT04930744)
- Testing
- Isoniazid, Rifampicin, Ethambutol
- Where
- 2 sites in South Africa
- Volunteers
- 112 people
- Sponsor
- University of Massachusetts, Worcester
Infections, Streptococcal
Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine
This study will evaluate safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ when co-administered with DTPw-HBV/Hib and OPV or IPV vaccines, according to 2 different…
- Trial name
- NCT00344318
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Prevenar, Tritanrix-HepB
- Where
- 7 sites in Philippines, Poland
- Volunteers
- 806 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Poliomyelitis
Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia
The purpose of this study is to assess reactogenicity and safety of simultaneous administration of GSK Biologicals' inactivated poliomyelitis vaccine Poliorix and GSK Biologicals' DTPa-vaccine Infanrix vaccines in healthy…
- Trial name
- NCT01094171
- Testing
- Poliorix TM, Infanrix TM
- Where
- 2 sites in Russia
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Acellular Pertussis
Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines
The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals' DTaP-IPV…
- Conditions
- Tetanus, Acellular Pertussis, Diphtheria
- Trial name
- NCT00148941
- Testing
- SB213503 lot 1, SB213503 lot 2, SB213503 lot 3
- Where
- 24 sites in United States
- Volunteers
- 4,209 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older
The purpose of this study is to investigate the immunogenicity and safety when GSK Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with Merck \& Co.
- Trial name
- NCT02218697
- Testing
- Influsplit™ Tetra (Fluarix™ Tetra), Pneumovax™ 23
- Where
- 6 sites in Belgium, France
- Volunteers
- 357 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Infection
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.
- Trial name
- NCT01340898
- Testing
- Meningococcal vaccine GSK 134612, SynflorixTM, Infanrix-IPV/HiberixTM
- Where
- 2 sites in Lebanon, Mexico
- Volunteers
- 753 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bacterial Vaginosis, Candidiasis
Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
This research study is about vaginal infections such as bacterial vaginosis, yeast infections, and trichomoniasis. Usually, these infections can be treated with medication, but sometimes they come back after treatment.
- Conditions
- Bacterial Vaginosis, Candidiasis, Trichomoniasis
- Trial name
- NCT01230814
- Testing
- Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate)
- Where
- 4 sites in United States, Kenya
- Volunteers
- 234 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infections, Papillomavirus
Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a…
- Trial name
- NCT00369824
- Testing
- Different formulations of GSK Biologicals' HPV vaccine (580299), Menactra TM, Boostrix TM
- Where
- 50 sites in United States
- Volunteers
- 1,330 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
This study aims to evaluate the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with diphtheria, tetanus, acellular pertussis-hepatitis…
- Trial name
- NCT00390910
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Infanrix hexa
- Where
- 8 sites in Greece, Spain
- Volunteers
- 286 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neisseria Meningitidis, Haemophilus Influenzae Type b
Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT (MenHibrix®) Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT (MenHibrix®) vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB…
- Trial name
- NCT01978093
- Testing
- Hib-MenCY-TT (MenHibrix®), Pediarix®, Rotarix®
- Where
- 26 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine
The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed…
- Trial name
- NCT00911144
- Testing
- GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A), Wyeth-Lederle's Prevenar™, GSK Biologicals' Hiberix™
- Where
- 14 sites in South Korea
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
The purpose of this study is to demonstrate, in 18-55 year old adults, the consistency of different manufactured lots of meningococcal vaccine GSK134612, the non-inferiority of GSK134612 compared to licensed meningococcal vaccine…
- Trial name
- NCT00453986
- Testing
- Meningococcal vaccine GSK134612, Mencevax™ACWY, Fluarix™
- Where
- 4 sites in Lebanon, Philippines
- Volunteers
- 1,352 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Child Development
Antibiotic Resistance and Microbiome in Children Aged 6-59 Months in Nouna, Burkina Faso
The use of antibiotics has saved millions of human lives, however consumption of antibiotics can select for antibiotic resistant organisms and may lead to changes in commensal microbiome.
- Trial name
- ARMCA (NCT03187834)
- Testing
- Azithromycin, Amoxicillin, Cotrimoxazole
- Where
- 2 sites in United States, Burkina Faso
- Volunteers
- 252 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Tetanus, Acellular Pertussis
Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years
The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when co-administered with varicella (Varivax® [varicella virus vaccine live], Merck and Company) and (measles mumps rubella) MMR vaccines, compared…
- Conditions
- Tetanus, Acellular Pertussis, Diphtheria
- Trial name
- NCT00871117
- Testing
- GSK Biologicals'Kinrix®, Merck and Company's MMRII, Merck and Company's Varivax
- Where
- 11 sites in United States
- Volunteers
- 478 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Meningococcal
Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration
The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered…
- Trial name
- NCT00758264
- Testing
- Meningococcal vaccine GSK134612, Pneumococcal vaccine GSK1024850A
- Where
- 5 sites in Mexico, Taiwan
- Volunteers
- 363 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus
Evaluation of Immunogenicity and Safety of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus (DPT-IPV) Vaccine Squarekids Co-administered With GSK Biologicals' Human Rotavirus (HRV) Vaccine Rotarix (GSK444563) in Healthy Infants
The purpose of this study is to evaluate the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids administered with or without the GSK Biologicals' liquid Rotarix…
- Trial name
- NCT02907216
- Testing
- Squarekids, Rotarix
- Where
- 11 sites in Japan
- Volunteers
- 292 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
MDR-TB, HIV
A Nurse Case Management Intervention to Improve MDR-TB/HIV Co-Infection Outcomes
The researchers of this study are observing the treatment of multi-drug resistant Mycobacterium tuberculosis (MDR-TB) in South Africa. MDR-TB can not be treated with the usual TB drugs and needs to be treated with special drugs.
- Trial name
- NCT02129244
- Testing
- NCM-Plus
- Where
- 15 sites in South Africa
- Volunteers
- 2,844 people
- Sponsor
- Johns Hopkins University
Infections, Streptococcal, Streptococcus Pneumoniae
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
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
- NCT00814710
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Tritanrix-HepB/Hib, Hiberix
- Where
- 4 sites in India
- Volunteers
- 360 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline