Clinical trials: Healthy Infants
Evaluation of a Rotavirus Vaccine
Phase I/II Descending Age Study of P2VP8 Subunit Parenteral Rotavirus Vaccine in Healthy Toddlers and Infants
This is is a study of a parenteral rotavirus vaccine (P2-VP8 subunit rotavirus vaccine). The study will examine the safety and immunogenicity of this vaccine first in healthy South African toddlers.
- Trial name
- NCT02109484
- Testing
- P2-VP8 Subunit Vaccine 10mcg, P2-VP8 Subunit Vaccine 30 mcg, P2-VP8 Subunit Vaccine 60mcg
- Where
- South Africa
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- PATH
COVID-19
A Study to Learn About Bivalent COVID-19 RNA Vaccine Candidate(s) in Healthy Infants and Children
The purpose of this clinical trial is to learn about the safety and immune responses of the study vaccine (called a bivalent BNT162b2 Omicron containing vaccine) in healthy infants and children.
- Trial name
- NCT05630352
- Testing
- Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 6 microgram dose, Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 10 microgram dose
- Volunteers
- healthy volunteers welcome
- Sponsor
- BioNTech SE
Healthy
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
- Trial name
- NCT07160244
- Testing
- Multivalent Group B streptococcus vaccine, Infanrix hexa, Prevenar 20
- Where
- 219 sites in United States, Argentina and 13 more
- Volunteers
- 6,000 people, healthy volunteers welcome
- Sponsor
- Pfizer
Cystic Fibrosis
Muscle Accrual and Function in Cystic Fibrosis-Impact of Glucose Intolerance
This study will investigate the link between glucose abnormalities and elements critical to muscle function including mass, composition and energy metabolism.
- Trial name
- NCT02776098
- Where
- 2 sites in United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Child Development
Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants
This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control…
- Trial name
- NCT04013087
- Testing
- Oral feeding of Feihe Stage 1 infant formula, Oral feeding of control Stage 1 formula, Breast feeding
- Where
- 3 sites in China
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Heilongjiang Feihe Dairy Co. Ltd.
Cystic Fibrosis, Mucociliary Clearance
A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy Volunteers
The purpose of this study is to evaluate the safety and tolerability of repeated doses of GS-9411 in healthy volunteers. GS-9411 is a sodium channel inhibitor, that may restore airway hydration and mucociliary clearance in the…
- Conditions
- Cystic Fibrosis, Mucociliary Clearance, Airway Hydration
- Trial name
- NCT00999531
- Testing
- GS-9411
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Scabies
HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation
This is a clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation.
- Trial name
- HEALTH (NCT06918665)
- Testing
- ivermectin infant formula preparation, Standard ivermectin 3mg tablet
- Where
- Australia
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Murdoch Childrens Research Institute
Healthy Infants
Efficacy of Two HMOs in Chinese Infants
This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier…
- Trial name
- NCT06361719
- Testing
- Experimental Group (EG), Control Group (CG)
- Where
- China
- Volunteers
- 262 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
Healthy Infants
To Investigate Effects of a New Infant Formula in Healthy Term Chinese Infants
This study investigates the effects of a new infant formula on growth, safety, and tolerance in healthy term Chinese infants. Screening starts after the informed consent is obtained.
- Trial name
- NCT03520764
- Testing
- New infant formula with synbiotics, Standard infant formula with prebiotics
- Where
- 6 sites in China
- Volunteers
- 284 people, healthy volunteers welcome
- Sponsor
- Danone Nutricia
Osteoporosis, Obesity
Breastfeeding and Exercise for Healthy Infants and Postpartum Moms Too!
Approximately 8 million American women suffer from osteoporosis, and one out of every two women over the age of 50 will have an osteoporotic-related fracture in their lifetime (42).
- Conditions
- Osteoporosis, Obesity, Weight Loss
- Trial name
- BEHIP (NCT00966381)
- Testing
- Exercise and weight loss intervention
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Greensboro
Poliomyelitis
A Study to Evaluate Safety and Immunogenicity of Sequential Vaccination of Sabin Inactivated Poliomyelitis Vaccine (Vero Cell) and Live Attenuated Poliomyelitis Vaccine in Healthy 2-month-old Infants
The goal of this clinical trial is to evaluate the immunogenicity and safety of a Sabin Inactivated Poliomyelitis Vaccine (sIPV) and a commercially available Live Attenuated Poliomyelitis Vaccine (bOPV) according to the "2+1…
- Trial name
- NCT06752174
- Testing
- sIPV+bOPV, wIPV+bOPV
- Where
- China
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Beijing Minhai Biotechnology Co., Ltd
Meningococcal Disease
B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants
This study is aimed to assess whether the frequency of meningococcal serogroup A, C, W-135 and Y specific memory B Cells, measured 1 month after a primary vaccination series of Novartis MenACWY vaccine, predicts the specific…
- Trial name
- NCT00488683
- Testing
- MenACWY-CRM, DTaP-Hib-IPV, PCV
- Where
- United Kingdom
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Less Than 3 Months Old, Healthy Infants
An Intervention Study in Healthy Infants Aged 0-6 Months With Probiotics Lacticaseibacillus Rhamnosus LRa05 (LRa05) and Bifidobacterium Animalis Subsp. Lactis BLa80 (BLa80) vs. Placebo, for Promoting Gut Microbiome Development.
The probiotics Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa05 have potential to enhance infant health and development based on previous research conducted on human infants.
- Trial name
- SMILE (NCT07505329)
- Testing
- Probiotic
- Where
- Ireland
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- University College Cork
Bacterial Infections, Virus Diseases
A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.
- Trial name
- NCT01340937
- Testing
- V419, PENTACEL™, Prevnar 13™
- Volunteers
- 2,808 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Women, Caries of Infancy
The Effectiveness of Motivational Interviewing in Preventing Early Childhood Caries Among Mothers of Infants in Terengganu.
This study will be conducted in Ministry of Health (MOH) Maternal and Child Health Clinics (MCHCs) and MOH dental clinics in Setiu and Hulu Terengganu, selected for their similar sociodemographic characteristics.
- Trial name
- NCT07538219
- Testing
- Anticipatory Guidance Using Motivational Interviewing, Conventional Ministry of Health Anticipatory Guidance
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- Universiti Sains Malaysia
Infections, Rotavirus
Vaccine Efficacy Against Rotavirus Diarrhea; Vaccine Given With Routine Childhood Vaccinations in Healthy African Infants
The primary objective of this study is to determine if the GSK Biologicals' human rotavirus (HRV) vaccine (pooled HRV groups) given concomitantly with routine expanded program on immunisation (EPI) vaccinations can prevent severe…
- Trial name
- NCT00241644
- Testing
- Rotarix™
- Where
- 13 sites in Malawi, South Africa
- Volunteers
- 2,089 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
Breastmilk Expression, Collection, Breastmilk
Antenatal Breastmilk Expression From Week 34 of Gestation
In this pilot study, the investigators aim to examine if antenatal breastmilk expression from week 34 of pregnancy is a safe and feasible procedure for the mother and fetus.
- Conditions
- Breastmilk Expression, Collection, Breastmilk, Breastfeeding, Healthy
- Trial name
- EXPRESS-MOM (NCT05516199)
- Testing
- Antenatal breastmilk expression, Breastfeeding consultation
- Where
- Denmark
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Pneumococcal Infections, Pneumococcal Vaccines
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029)
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114…
- Trial name
- PNEU-PED (NCT03893448)
- Testing
- V114, Prevnar 13™, RotaTeq™
- Where
- 81 sites in United States, Puerto Rico and 2 more
- Volunteers
- 1,720 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Dermatitis, Atopic, Eczema, Infantile
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.
- Conditions
- Dermatitis, Atopic, Eczema, Infantile, Infant Development, Child Development
- Trial name
- GIraFFE (NCT04599946)
- Testing
- Infant formula and follow-on formula made from whole goat milk, Infant formula and follow-on formula made from cow's milk ingredients
- Where
- 12 sites in Germany, Poland and 1 more
- Volunteers
- 2,132 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited