Clinical trials: Healthy Infants
Tetanus, Diphtheria
Confirmatory Study of BK1310 in Healthy Infants
The purpose of this study is to evaluate immunogenicity of BK1310 for all antigens (anti-PRP, diphtheria toxin, pertussis, tetanus toxin, and polio virus), after 3 times of injection, when compared noninferiority with…
- Conditions
- Tetanus, Diphtheria, Pertussis, Poliomyelitis
- Trial name
- NCT03891758
- Testing
- DPT-IPV-Hib, Hib vaccine, DPT-IPV
- Where
- Japan
- Volunteers
- 267 people, healthy volunteers welcome
- Sponsor
- Tanabe Pharma Corporation
Healthy Infants
Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements
This is a double-blind, randomized, placebo-controlled nutritional study aimed at investigating growth, tolerance, and functional biomarkers in healthy infants receiving dietary supplements from birth to 2.5 months of age
- Trial name
- NCT07630584
- Testing
- Probiotic dietary supplement
- Where
- 2 sites in Philippines
- Volunteers
- 327 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Rotavirus
Immunogenicity, Reactogenicity and Safety Study of Two Different Formulations of GSK Biologicals' Human Rotavirus Vaccine, Rotarix, in Healthy Infants
The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' HRV liquid vaccine compared to GSK Biologicals' HRV lyophilized vaccine when administered as a two-dose primary…
- Trial name
- NCT02141204
- Testing
- HRV Liquid, HRV Lyophilized
- Where
- 8 sites in India
- Volunteers
- 451 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Meningococcal Disease
Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants
To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.
- Trial name
- NCT00433914
- Testing
- rMenB, rMenB+OMV
- Where
- United Kingdom
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Infant Nutritional Physiological Phenomena, Infant Formula
Gastrointestinal Tolerability of a Partially Hydrolyzed Ready-to-feed Infant Formula in Healthy Newborns
Gastrointestinal tolerability of a partially hydrolyzed, whey-based, ready-to-feed infant formula in healthy newborns during the birth hospitalization period: a post-market study
- Trial name
- NCT05097924
- Testing
- NAN Supreme HypoAllergenic Starter Infant Formula in ready-to-feed format
- Where
- Saudi Arabia
- Volunteers
- 150 people
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy Volunteers (Meningococcal Infection)
Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers in the Russian Federation and Mexico
Primary Objective: 1. To describe the vaccine seroprotection (antibody titer greater than or equal to [>=] 1:8) to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW Conjugate vaccine or Menveo® measured by…
- Trial name
- MET33 (NCT03630705)
- Testing
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine, Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine, Measles, Mumps, and Rubella Virus Vaccine Live
- Where
- 11 sites in Mexico, Russia
- Volunteers
- 525 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Rotavirus Infections
Consistency Lots Vaccine Study (V260-009)
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
- Trial name
- NCT00092456
- Testing
- rotavirus vaccine, live, oral, pentavalent
- Volunteers
- 793 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration
This is a Phase 1, first-in-human (FIH) single ascending dose study being conducted to better understand the safety, tolerability and pharmacokinetics of AZD5634 in healthy subjects
- Trial name
- NCT02679729
- Testing
- AZD5634 for inhalation, AZD5634 for infusion
- Where
- 2 sites in United States
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hepatitis B
Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine
This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course…
- Trial name
- NCT00880477
- Testing
- DTPa-HBV-IPV/Hib vaccine, DTPa-IPV/Hib vaccine, EngerixTM-B
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Rotavirus Gastroenteritis
Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization
This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
- Trial name
- NCT02584816
- Testing
- BRV-PV Lot A + DPT-HepB-Hib + OPV, BRV-PV Lot B + DPT-HepB-Hib + OPV, BRV-PV Lot C + DPT-HepB-Hib + OPV
- Where
- 10 sites in India
- Volunteers
- 1,500 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Rotavirus Disease
Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)
The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants.
- Trial name
- NCT01926015
- Testing
- RotaTeq™ (V260), DTP-IPV
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
Effect of Vanzacaftor/Tezacaftor/Deutivacaftor (VNZ/TEZ/D-IVA) on the PK of Rosuvastatin in Healthy Participants
The purpose of this study is to evaluate the effect of multiple doses of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) on the PK of rosuvastatin and the safety and tolerability of coadministration of VNZ/TEZ/D-IVA with…
- Trial name
- NCT07349394
- Testing
- VNZ/TEZ/D-IVA, Rosuvastatin
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Healthy
Immune Health Biomarkers and Fecal Microbiota in Filipino Breastfed Infants
This will be a prospective observational study aiming to investigate immune health biomarkers and fecal microbiota in 48-60 Filipino breastfed infants from birth to 12 months of age.
- Trial name
- NCT06708559
- Testing
- Breast-fed infants
- Where
- Philippines
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Diphtheria, Tetanus
Study of an Investigational Vaccine in Healthy Infants in Taiwan (V441-001)(COMPLETED)
The purpose of this study is to evaluate the safety, tolerability, and immune response of an investigational vaccine being evaluated to reduce the incidence of diphtheria, pertussis, tetanus, hepatitis B, poliomyelitis, and…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT00092469
- Testing
- V441, diptheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant), & Haemophilus influenza type b conjugate vaccine
- Volunteers
- 151 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Tolerance of Healthy, Term Infants to Infant Formulas
To assess the gastrointestinal tolerance of healthy full-term infants fed either experimental formula or a control formula
- Trial name
- NCT00543673
- Testing
- Milk based formula A, #2 Standard formula, #3 Human Milk
- Where
- 10 sites in United States
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Abbott Nutrition
Healthy
Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition
A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as reference from birth to 1 year of age and a…
- Trial name
- NCT02282488
- Testing
- Low protein formula, High protein formula
- Where
- France
- Volunteers
- 238 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Cystic Fibrosis
Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers
The purpose of this study is to evaluate the safety and tolerability of escalating doses of GS-9411 in healthy male volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in…
- Trial name
- NCT00800579
- Testing
- GS-9411
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Phase 1, QT/QTC Interval Study in Healthy Subjects
This study is designed to evaluate the effect of multiple doses of lumacaftor in combination with ivacaftor on cardiac repolarization, as detected by QT/QTc interval corrected for heart rate in healthy subjects.
- Trial name
- NCT01910415
- Testing
- Lumacaftor, Ivacaftor, moxifloxacin hydrochloride
- Where
- Netherlands
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Nutritional Safety
Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS)
The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with a "prebiotic" component (GOS) in improving the gut microflora balance, mimicking that of breast-fed infants.
- Trial name
- NCT00486148
- Testing
- Infant formula (with GOS)
- Where
- 7 sites in Italy
- Volunteers
- 360 people
- Sponsor
- Heinz Italia SpA
Immune Response to DTP-HB-Hib Vaccine
Study Comparing DTP-HB-Hib by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Infants
This is a study planned to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian…
- Trial name
- NCT02409095
- Testing
- DTP-HB-Hib vaccine, Disposable Syringe Jet Injector (DSJI), Needle & Syringe
- Where
- 3 sites in India
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.