Clinical trials: Pediatric Infectious Disorder
SARS-CoV2 Infection
COVAXIN in a Pediatric Cohort
The study is designed to evaluate the safety, reactogenicity and immunogenicity of three groups ages ≤18 - >12, ≤12 ->6, ≤ 6 - >2 years of healthy volunteers who receive two doses of the whole virion inactivated SARS-CoV-2 virus…
- Trial name
- COVAXIN-Peds (NCT04918797)
- Testing
- COVAXIN
- Where
- 7 sites in India
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Bharat Biotech International Limited
HIV Infections
Dolutegravir Study in HIV-1 Participants Completing IMPAACT Studies P1093 and P2019
Dolutegravir is a potent integrase strand transfer inhibitor. Abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) is a fixed dose combination regimen containing two nucleoside reverse transcriptase inhibitors and dolutegravir.
- Trial name
- NCT03016533
- Testing
- Dolutegravir film-coated tablets, Dolutegravir film-coated dispersible tablets, ABC/DTG/3TC immediate release tablets
- Where
- 17 sites in United States, Botswana and 5 more
- Volunteers
- 100 people
- Sponsor
- ViiV Healthcare
HIV Infections
Pharmacokinetics and Safety Study of Tipranavir in Combination With Low Dose Ritonavir in Human Immunodeficiency Virus (HIV)-Infected Children
The primary objective of this study is to assess the safety and tolerability of tipranavir (TPV) oral formulation and soft gelatin capsules together with low-dose ritonavir in HIV-infected children and adolescents, to provide…
- Trial name
- NCT00076999
- Testing
- TPV oral solution, RTV oral solution
- Where
- 30 sites in United States, Argentina and 8 more
- Volunteers
- 115 people
- Sponsor
- Boehringer Ingelheim
Chronic Hepatitis B Virus, Pediatric
A Phase III Study of the Safety and Efficacy of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus Infection
The purpose of this study was to evaluate the safety and efficacy of entecavir in pediatric patients with chronic hepatitis B virus infection
- Trial name
- NCT01079806
- Testing
- Entecavir
- Where
- 44 sites in United States, Argentina and 12 more
- Volunteers
- 180 people
- Sponsor
- Bristol-Myers Squibb
Diphtheria, Pertussis
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H.
- Conditions
- Diphtheria, Pertussis, Polio, Hepatitis B
- Trial name
- NCT00362427
- Testing
- Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
- Where
- 8 sites in Canada
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are: To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine…
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01444781
- Testing
- DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide, DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide, DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 1,106 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Ear Infection
Application of the Belle.AI Comparative Image Reference System for Describing Chronic Ear Infections in Pediatric Patients From Low-Resource Communities
The purpose of this research is to examine the clinical effectiveness of an investigational AI-powered smartphone app that describes the physical characteristics of an otoscopy image. It is not intended to make any diagnosis.
- Trial name
- Otoscopy AI (NCT07025473)
- Testing
- Smartphone-enabled otoscopy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- BelleTorus Corporation
Respiratory Tract Infections (RTI), Influenza-like Illness
Clinical Assessment of Respiratory Events for Kids: Integrating Diagnostics and Stewardship
This study, called Care4Kids, aims to improve the management of respiratory infections in children visiting emergency departments.
- Conditions
- Respiratory Tract Infections (RTI), Influenza-like Illness, Children
- Trial name
- CARE4KIDS (NCT07453914)
- Testing
- SPOTFIRE R
- Where
- 3 sites in France, Greece and 1 more
- Volunteers
- 720 people
- Sponsor
- BioMérieux
Pediculosis
Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation
A pharmacokinetic and tolerance study of Natroba (spinosad) Topical Suspension, 0.9% in pediatric subjects 6 months to 4 years of age with an active head lice infestation.
- Trial name
- NCT01660321
- Testing
- spinosad
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- ParaPRO LLC
Severe Respiratory Syncytial Virus Infection
Retrospective Palivizumab Study in Children With Hemodynamically Significant Congenital Heart Disease
Retrospective medical record review study of specific adverse events in children with congenital heart disease who received palivizumab for prophylaxis of serious respiratory syncytial virus infection and control subjects that…
- Trial name
- NCT01075178
- Where
- 37 sites in Austria, Belgium and 8 more
- Volunteers
- 2,036 people
- Sponsor
- Abbott
Healthy Volunteers (Meningococcal Infection)
Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the US
The purpose of this study was to compare the immunogenicity and describe the safety of MenACYW conjugate vaccine and MENVEO® when both are administered concomitantly with routine pediatric vaccines to healthy infants and toddlers…
- Trial name
- NCT03537508
- Testing
- MenACYW conjugate vaccine, MenACYW-135 conjugate vaccine, DTaP-IPV//Hib vaccine
- Where
- 70 sites in United States, Puerto Rico
- Volunteers
- 2,627 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis B
Pharmacokinetics and Safety of Single-Dose Telbivudine in Children and Adolescents With Chronic Hepatitis B
This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.
- Trial name
- NCT00907894
- Testing
- LDT600 (Telbivudine)
- Where
- 7 sites in Belgium, Germany and 2 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Respiratory Syncytial Virus Infections
A Study to Learn About the Amount of the Study Medicine (Sisunatovir) in Blood and Its Safety in Infants and Children With Pneumonia Caused by RSV
The purpose of the study is to learn about the safety and amount of sisunatovir in the blood of infants and children up to age 60 months.
- Trial name
- NCT06102174
- Testing
- Active
- Where
- 9 sites in United States, Japan and 1 more
- Volunteers
- 10 people
- Sponsor
- Pfizer
Meningococcal Meningitis, Measles
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered…
- Conditions
- Meningococcal Meningitis, Measles, Mumps, Rubella
- Trial name
- NCT00483574
- Testing
- Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate, Measles-mumps-rubella-varicella vaccine, Routine paediatric vaccine - Pneumococcal conjugate (PCV)
- Where
- 79 sites in United States, Chile
- Volunteers
- 1,378 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Viral Infection, Bacterial Infections
A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection
To externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in pediatric patients >3…
- Conditions
- Viral Infection, Bacterial Infections, Antibiotic Misuse, Host Response Diagnostics
- Trial name
- ROSETTA (NCT04254991)
- Testing
- ImmunoXpert™
- Volunteers
- 525 people
- Sponsor
- MeMed Diagnostics Ltd.
HIV Infections
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
- Trial name
- NCT00002219
- Testing
- Nelfinavir mesylate, Levocarnitine, Adefovir dipivoxil
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Gilead Sciences
HIV Infections
A Study of 1592U89 in HIV-Infected Children
The purpose of this study is to see if it is safe to give 1592U89 to children (aged 6 months until 14th birthday) with advanced HIV infection who have few treatment options available.
- Trial name
- NCT00002197
- Testing
- Abacavir sulfate
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Glaxo Wellcome
Skin Diseases, Infectious
Safety and Efficacy Study of Daptomycin in Pediatric Participants (1 to 17 Years-old) With Skin and Skin Structure Infections
This is a multi-center, evaluator-blinded, randomized, comparative study designed to assess the safety, efficacy, and pharmacokinetics (PK) of daptomycin in pediatric subjects ages 1 to 17 years, inclusive, with complicated skin…
- Trial name
- NCT00711802
- Testing
- Daptomycin, Standard of Care (SOC)
- Where
- 30 sites in United States, India and 1 more
- Volunteers
- 396 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
RSV Infection, RSV
A Phase 2 Study to Investigate the Efficacy and Safety of Zelicapavir in Participants Aged ≥28 Days to ≤36 Months of Age Infected With Respiratory Syncytial Virus
Zelicapavir is a novel, orally administered, nonfusion replication inhibitor of RSV. It is being investigated in this Phase 2 study (EDP 938-203) as a potential treatment for RSV infection in both hospitalized and…
- Conditions
- RSV Infection, RSV, Respiratory Syncytial Virus (RSV)
- Trial name
- NCT07482657
- Testing
- zelicapavir
- Where
- 8 sites in Thailand
- Volunteers
- 150 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Hepatitis C Infection
A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir
Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets. Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet
- Trial name
- NCT02323594
- Testing
- Daclatasvir, Asunaprevir
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb