Clinical trials: Children Aged 3-5 Years
Respiratory Tract Infections
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
The purpose of the study is to evaluate the efficacy of rilematovir compared to placebo treatment with respect to the clinical outcome on the RSV Recovery Scale (RRS).
- Trial name
- DAISY (NCT04583280)
- Testing
- Rilematovir, Rilematovir X mg/kg
- Where
- 142 sites in United States, Argentina and 24 more
- Volunteers
- 28 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis B
A Study to Assess the Anamnestic Immune Response in Healthy 4 to 7 Year-old Children After a Primary Vaccination Series With Either HEXAVAC® or INFANRIX®-HEXA
Primary objective: To describe in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA during the first two years of life the percentage of subjects with an anti-HBs antibody titre ≥10 mIU/mL 1 month after a…
- Trial name
- NCT00693186
- Testing
- HBVaxPRO® 5 µg / 0.5 mL, Engerix B® 10 µg / 0.5 mL
- Where
- 5 sites in Italy
- Volunteers
- 410 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Infections, Meningococcal
Safety & Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years.
- Trial name
- NCT00196976
- Testing
- Conjugated meningococcal ACWY-TT (vaccine), DTPa-IPV/Hib vaccine (Infanrix™-IPV/Hib), DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)
- Where
- 17 sites in Austria, Greece
- Volunteers
- 461 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malaria
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Candidate Vaccines RTS,S/AS02D (0.5 mL Dose) and RTS,S/AS02A (0.25 mL Dose) Administered IM According to a 0, 1, 2 Month Vaccination Schedule in Children Aged 3 to 5 Years Living in a Malaria-endemic Region of Mozambique.
GSK Biologicals is developing in partnership with the Malaria Vaccine Initiative at PATH a candidate malaria vaccine RTS,S/AS02 for the routine immunization of infants and children living in malaria endemic areas.
- Trial name
- NCT00197067
- Testing
- RTS,S/AS02D and RTS,S/AS02A
- Where
- Mozambique
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Asthma
Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)
The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.
- Trial name
- NCT01615874
- Testing
- MF/F Metered Dose Inhaler (MDI) 25/5 mcg, MF/F MDI 50/5 mcg, MF/F MDI 100/5 mcg
- Sponsor
- Organon and Co
Cradle Cap, Seborrheic Dermatitis
TRIDERM D.S. Crema Normalizzante for Neonatal Hyperseborrhea (Cradle Cap) and Associated Cutaneous Manifestations of Mild-to-Moderate Seborrheic Dermatitis in Children Aged 0 to 3 Years
This clinical study aims to evaluate the effects of using the cosmetic product TRIDERM D.S. Crema Normalizzante in children aged 0 to 3 years with neonatal hyperseborrhea ("cradle cap"), potentially associated with manifestations…
- Trial name
- NCT07860788
- Testing
- TRIDERM D.S. Crema Normalizzante
- Where
- Italy
- Volunteers
- 20 people
- Sponsor
- ICIM International S.r.l.
Neurogenic Detrusor Overactivity, Pediatric
A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)
The purpose of this study was to evaluate long term efficacy and safety of treatment with solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after multiple dose administration.
- Trial name
- NCT01981954
- Testing
- Solifenacin succinate
- Where
- 8 sites in United States, Belgium and 4 more
- Volunteers
- 23 people
- Sponsor
- Astellas Pharma Europe B.V.
Urinary Bladder, Overactive
A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults.
- Trial name
- LION (NCT01565707)
- Testing
- Solifenacin Succinate Suspension, Urotherapy
- Where
- 46 sites in United States, Belgium and 14 more
- Volunteers
- 189 people
- Sponsor
- Astellas Pharma Europe B.V.
Autism Spectrum Disorder
Study of Cariprazine Oral Capsules or Solution to Assess Adverse Events and Change in Irritability Due to Autism Spectrum Disorder (ASD) in Participants Aged 5-17 Years With ASD
Autism spectrum disorder (ASD) consists of deficits in social, communication, and cognitive development, repetitive and stereotypic behaviors.
- Trial name
- NCT05439616
- Testing
- Cariprazine
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 161 people
- Sponsor
- AbbVie
Irritability Associated With Autism Spectrum Disorder
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
- Trial name
- NCT07285798
- Testing
- KarXT, KarX-EC
- Where
- 67 sites in United States, France and 8 more
- Volunteers
- 176 people
- Sponsor
- Bristol-Myers Squibb
Fragile X Syndrome
Clinical Study to Assess the Pharmacokinetics, Safety and Tolerability of Single and Multiple Oral Doses of AFQ056 in Children With Fragile X Syndrome (FXS)
The aim of this study is to characterize the pharmacokinetics and safety/tolerability of AFQ056 in children with Fragile X Syndrome(FXS)
- Trial name
- NCT01482143
- Testing
- AFQ056
- Where
- 4 sites in United States, Spain
- Volunteers
- 21 people
- Sponsor
- Novartis Pharmaceuticals
Fever, Acute Pain
Using a Decision-making System to Support the Management of Fever and Acute Pain in Children
FEVER is a single-center, prospective, open-label, pre-market, pivotal, single-arm study aimed at demonstrating how the use of an algorithm integrated with a Class I Medical Device (Puntofarma®), which is made available through a…
- Trial name
- FEVER (NCT07344090)
- Testing
- Puntofarma® FEVER
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- Qwince Innovation S.r.l.
COVID-19, SARS-COV-2 Infection
A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That Are Considered at Higher Risk of Severe COVID-19
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of an updated vaccine against COVID-19, called BNT162b2 (2025/2026 formulation).
- Trial name
- NCT07222384
- Testing
- BNT162b2 (2025/2026 formulation)
- Where
- 29 sites in United States, Puerto Rico
- Volunteers
- 344 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Infections, Meningococcal
Study in Children to Evaluate the Immunogenicity and Safety of 4 Formulations of GSK Bio MenACWY-TT Conjugate Vaccine
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12 14 months and 3 5 years.
- Trial name
- NCT00126984
- Testing
- Conjugated meningococcal ACWY-TT (vaccine), DTPa/Hib containing vaccine, Meningitec
- Where
- 42 sites in Austria, Germany
- Volunteers
- 508 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Burns
Study of the Efficacy and Safety of Kalinox® 170 Bar for the Performance of Care Procedures in Children With Burns
The purpose of this study is to assess the efficacy and the safety of Kalinox® 170 bar, over a period of three consecutive care procedures in burned children.
- Trial name
- Burns (NCT00643357)
- Testing
- 50% Oxygen/50% Nitrous oxide premix (KALINOX 170 bar), 50%Oxygen/50% Nitrogen premix
- Sponsor
- Air Liquide Santé International
Lyme Disease
Safety Study of a Vaccine to Help Protect Against Lyme Disease in Healthy Children
This study is to understand if the study vaccine (called VLA15) is safe in healthy children. We are looking for children who: are healthy are age 5 through 17 have not been diagnosed with any form of Lyme disease in the past have…
- Trial name
- NCT05634811
- Testing
- VLA15, Normal Saline
- Where
- 65 sites in United States
- Volunteers
- 3,547 people, healthy volunteers welcome
- Sponsor
- Pfizer
Attention Deficit Hyperactivity Disorder (ADHD)
Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)
The purpose of this study is to determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version in children 4-5 years old diagnosed with ADHD.
- Trial name
- NCT03260205
- Testing
- SPD489 (Lisdexamfetamine dimesylate), SPD489
- Where
- 48 sites in United States
- Volunteers
- 199 people
- Sponsor
- Shire
COVID-19
Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)
This study is a randomized and controlled Phase IV clinical trial of the COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co., Ltd.
- Trial name
- NCT05107557
- Testing
- Experimental Group
- Where
- 2 sites in China
- Volunteers
- 520 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Active Juvenile Psoriatic Arthritis
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
The study will aim to estimate the efficacy of apremilast compared with placebo in the treatment of juvenile psoriatic arthritis (JPsA) in pediatric participants 5 to less than 18 years of age.
- Trial name
- PEAPOD (NCT04804553)
- Testing
- Apremilast
- Where
- 44 sites in Belgium, France and 12 more
- Volunteers
- 60 people
- Sponsor
- Amgen
Atopic Dermatitis
5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical…
- Trial name
- NCT00120523
- Testing
- Pimecrolimus, Topical corticosteroids
- Where
- 31 sites in United States, Germany
- Volunteers
- 2,418 people
- Sponsor
- MEDA Pharma GmbH & Co. KG