Clinical trials: Infant
Congenital Rubella Infection, Measles
Immunogenicity & Safety of Bio Farma's Measles-Rubella (MR) Vaccine in Indonesian Infants (Bridging Study)
Thus study is a clinical trial for Measles and Rubella vaccine that will be used inIndonesian National Program of Immunization. The study design will be randomized, observer blind, prospective intervention study.
- Trial name
- NCT04183114
- Testing
- Measles-Rubella vaccine Bio Farma, MR Vaccine SII
- Where
- Indonesia
- Volunteers
- 540 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Cystic Fibrosis
Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients
The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.
- Trial name
- DPM-PK-102 (NCT00792714)
- Testing
- Mannitol
- Where
- 4 sites in Australia, United Kingdom
- Volunteers
- 18 people
- Sponsor
- Syntara
Glaucoma, Ocular Hypertension
Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients
The purpose of this study was to assess the safety and describe the steady-state plasma pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation) following a once daily administration for 7 days in…
- Trial name
- NCT01658839
- Testing
- Travoprost ophthalmic solution, 0.004% (new formulation)
- Volunteers
- 25 people
- Sponsor
- Alcon Research
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
Pneumococcal Vaccines, Pneumococcal Infections
A Phase 3 Study to Evaluate the Immunogenicity and Safety of Minhai's PCV13-DT/TT Vaccine As Compared to Pfizer's PCV13 Vaccine
The goal of this clinical trial is to evaluate the immunogenicity and safety of Minhai's 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13-DT/TT) as compared to Pfizer's 13-valent Pneumococcal Conjugate Vaccine…
- Trial name
- NCT06608199
- Testing
- pneumococcal disease prevention
- Where
- 3 sites in Indonesia
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Beijing Minhai Biotechnology Co., Ltd
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF3 (NCT00128492)
- Testing
- AZLI 75 mg two times a day (BID)/ three times a day (TID)
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Healthy
Immunogenocity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
To Asses the Immunogenicity and Safety of Flubio (Influenza HA) Vaccine in Infants and Children (Bridging Study)
- Trial name
- NCT02093260
- Testing
- Vaccine
- Where
- 2 sites in Indonesia
- Volunteers
- 405 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Retinopathy of Prematurity
RAINBOW Study: RAnibizumab Compared With Laser Therapy for the Treatment of INfants BOrn Prematurely With Retinopathy of Prematurity
The purpose of this study was to determine if intravitreal ranibizumab is superior to laser ablation therapy in the treatment of retinopathy of prematurity (ROP).
- Trial name
- RAINBOW (NCT02375971)
- Testing
- Ranibizumab, Laser therapy
- Where
- 86 sites in United States, Austria and 24 more
- Volunteers
- 224 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
- Trial name
- NCT06460506
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 18 sites in Australia, Canada and 5 more
- Volunteers
- 50 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Hunter Syndrome
An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do…
- Trial name
- NCT00882921
- Testing
- Idursulfase
- Where
- 6 sites in United States, Brazil and 1 more
- Volunteers
- 26 people
- Sponsor
- Shire
Infectious Disease by Haemophilus Influenzae Type b
Immunogenicity and Safety Study of LBVH0101 in Healthy Infants at Two, Four and Six Months of Age
The purpose of this study is to evaluate and compare the immunogenicity and safety of LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) to that of Hiberix™ at vaccination in healthy infants at their 2, 4…
- Trial name
- NCT01019772
- Testing
- LBVH0101 (Hib vaccine), Hiberix™ Vaccine
- Where
- South Korea
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Norovirus Infections
A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants
The primary objective of this study is to evaluate the safety and tolerability of an oral bivalent GI.1/GII.4 norovirus vaccine administration in healthy lactating female participants and to assess the short-term immunogenicity…
- Trial name
- NCT07254728
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS
- Where
- 5 sites in South Africa
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Vaxart
Atopic Dermatitis, Eczema
Daily Use of Lipikar Balm AP From Birth in Infants at High Risk of Developing Atopic Dermatitis
There is a lack of prospective scientific data on the regular use of moisturizers in patients at risk of developing atopic dermatitis.
- Conditions
- Atopic Dermatitis, Eczema, Asthma, Food Allergies
- Trial name
- NCT01577628
- Testing
- Lipikar Balm AP
- Where
- 4 sites in United States, Canada
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Cosmetique Active International
Skin; Deformity
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only).
- Trial name
- NCT03624192
- Testing
- RECELL® Autologous Cell Harvesting Device, Telfa™ Clear and Xeroform™ dressings
- Where
- 7 sites in United States
- Volunteers
- 3 people
- Sponsor
- Avita Medical
Lactating Women, Breastfed Infants
A Lactation Study in Women Receiving Treatment With Ozanimod
The purpose of this study is to assess the concentrations of ozanimod and its major metabolites in breast milk and the effects on breastfed infants.
- Trial name
- NCT06181630
- Testing
- Breast milk, plasma, and blood samples
- Where
- United States
- Sponsor
- Bristol-Myers Squibb
Atopic Dermatitis, Pediatric ALL
TRacking Atopic Dermatitis Infants and Their Microbiome (TRAM)
TRacking Atopic dermatitis Infants and their Microbiome: A study to primarily assess the user experience of parents of infants with early onset eczema and parents of healthy infants on OneBiome real-world evidence research…
- Trial name
- TRAM (NCT06578351)
- Where
- Singapore
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Declarative Memory
The Effect of Feeding Infant Formula With Enriched Protein Fractions in the US
This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.
- Trial name
- NCT02433600
- Testing
- Cow's milk-based infant formula, Cow milk-based infant formula with enriched protein fractions
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Mead Johnson Nutrition
Healthy Newborn Infants
Safety and Efficacy of Addition of Structured Lipids in Starter Formulas
The primary objective of this trial is to demonstrate that infants receiving an infant formula in which 40 or 50% of the palmitic acid is in the sn-2 position have, during the first 4 months of life, stools that are softer than…
- Trial name
- NCT02332967
- Testing
- Whey predominant starter formula, Whey predominant starter formula + 40% palmitic acid, Whey predominant starter formula + 50% palmitic acid
- Volunteers
- 488 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Cystic Fibrosis
A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation
This is a Phase 4, randomized, double-blind, placebo-controlled, parallel-group study in subjects aged 12 years and older with CF who are homozygous for the F508del-CFTR mutation.
- Trial name
- NCT02875366
- Testing
- LUM/IVA
- Where
- 12 sites in Australia, United Kingdom
- Volunteers
- 70 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Congenital Hyperinsulinism
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to…
- Trial name
- NCT04172441
- Testing
- dasiglucagon
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Zealand Pharma