Clinical trials: Infant
Premature Birth of Newborn
Supporting and Enhancing NICU Sensory Experiences (SENSE)
Seventy preterm infants born less than or equal to 32 weeks gestation were put into either the sensory-based intervention (experiment) group or traditional care (control) group. Consecutive admissions at St.
- Trial name
- SENSE (NCT03316547)
- Testing
- SENSE Program
- Where
- United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
Sleep, Pregnancy
Halifax PrenaBelt Trial
Back and right-sided sleeping position in pregnant women has recently emerged as a potential risk factor for low birthweight (LBW) and stillbirth (SB) in the medical literature.
- Conditions
- Sleep, Pregnancy, Stillbirth, Infant, Low Birth Weight
- Trial name
- NCT02377817
- Testing
- PrenaBelt
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Allan Kember
Preterm Infant, Full-term Infant
A Novel Parent Education Program for Early Intervention
One in ten infants born in the USA is born preterm before 37 weeks of gestation and 50% of those will have motor and cognitive delays requiring intervention at school age.
- Trial name
- NCT04266717
- Testing
- Baby Play Intervention, Milestone Education
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Delaware
Hepatitis B, Polio
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00315055
- Testing
- DTaP-IPV-HB-PRP~T vaccine, DTaP-IPV//PRP~T combined, Hepatitis B vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 310 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
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
Bronchiolitis, Bronchiolitis, Viral
Nasal and Bronchial Absorption Sampling in RSV Bronchiolitis
This study will compare the novel methods of NS and BS with the standard technique of nasophayngeal aspiration (NPA) and routine ETT suction.
- Conditions
- Bronchiolitis, Bronchiolitis, Viral, RSV Infection, Respiratory Failure
- Trial name
- RSV-SAM (NCT03062917)
- Testing
- Nasal and Bronchial Sampling
- Where
- United Kingdom
- Volunteers
- 152 people, healthy volunteers welcome
- Sponsor
- Imperial College Healthcare NHS Trust
Respiratory Syncytial Virus Infection
Study on a Live-attenuated Respiratory Syncytial Virus Vaccine for Assessment of Safety, Transmissibility, and Genetic Stability of the Vaccine Virus Among Close Contacts in Infants and Toddlers 6 to < 24 Months of Age in Puerto Rico (USA)
The primary purpose of the study is to assess the shedding, transmission, and genetic stability of the live-attenuated RSVt vaccine after each intranasal vaccination (56 days apart) in infants and toddlers 6 to < 24 months of age.
- Trial name
- NCT05687279
- Testing
- RSVt Vaccine, Control Group
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Meningococcal Disease
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine
The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability…
- Trial name
- NCT01027351
- Testing
- Meningococcal (group B) multicomponent recombinant adsorbed vaccine., Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)
- Where
- United Kingdom
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Diarrhoea
A Study on the Safety and Immune Responses to the GVGH altSonflex1-2-3 Vaccine Against Shigellosis in Adults, Children, and Infants
The aim of the current clinical study was to evaluate, for the first time in humans (FTIH), the safety and immunogenicity of the altSonflex1-2-3 candidate vaccine against S. sonnei and S. flexneri serotypes 1b, 2a, and 3a.
- Trial name
- NCT05073003
- Testing
- AltSonflex1-2-3 High Dose, AltSonflex1-2-3 Medium Dose, AltSonflex1-2-3 Low Dose
- Where
- 2 sites in Belgium, Kenya
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Breast Feeding
Newborn Feeding and Infant Phenotype
Breast feeding is believed to be beneficial to long-term health but how these effects are mediated is unknown. I suggest that this may be through effects on body composition and metabolism.
- Trial name
- NCT02033005
- Where
- United Kingdom
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Poliomyelitis, Tetanus
Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
This study is designed to evaluate the safety and immunogenicity of Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age.
- Conditions
- Poliomyelitis, Tetanus, Acellular Pertussis, Diphtheria
- Trial name
- NCT01309646
- Testing
- Infanrix™-IPV+Hib, Infanrix™ IPV, Hiberix™
- Where
- 11 sites in South Korea
- Volunteers
- 454 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing
Primary: The rating by the primary caregivers on the use and relevance of data provided by the Language ENvironment Analysis (LENA) recorder and their level of engagement due to the content on the Cool mobile app.
- Trial name
- COOL (NCT03729960)
- Testing
- LENA recorder
- Where
- Singapore
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Malaria, Malaria Vaccines
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
GSK Biologicals in partnership with the Malaria Vaccine Initiative at PATH is developing a candidate malaria vaccine GSK 257049 for the routine immunization of infants and children living in malaria endemic areas.
- Trial name
- NCT00289185
- Testing
- RTS,S/AS02D, Engerix-B®, TETRActHib™
- Where
- Tanzania
- Volunteers
- 340 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
Crohn's Disease, Ulcerative Colitis
Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease
Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications.
- Conditions
- Crohn's Disease, Ulcerative Colitis, Healthy Controls
- Trial name
- NCT03397108
- Testing
- The IBD group was divided into 2 subgroups: with or without anti-TNF antibody use
- Where
- 2 sites in Canada
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- The Hospital for Sick Children
Poliomyelitis
Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants
The study will evaluate the safety and reactogenicity of Poliorix given as primary vaccination course to Chinese children at 2, 3 and 4 months of age.
- Trial name
- NCT00937404
- Testing
- Poliorix
- Where
- China
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pneumococcal Infections
Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants
This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio…
- Trial name
- NCT03550313
- Testing
- Multivalent, Prevnar 13
- Where
- 48 sites in United States
- Volunteers
- 565 people, healthy volunteers welcome
- Sponsor
- Pfizer
Congenital Hearing Loss
Communities Helping the Hearing of Infants by Reaching Parents
Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Children that are born with hearing loss have to undergo several hearing tests to diagnose the condition and many…
- Trial name
- CHHIRP (NCT03875339)
- Testing
- Navigator Guidance
- Where
- 2 sites in United States
- Volunteers
- 2,699 people, healthy volunteers welcome
- Sponsor
- Matthew Bush, MD
Diarrhoea
A Study on the Immune Response and Safety of a Multicomponent Shigella Vaccine in Preventing Shigellosis in Infants
This study evaluates the immune response and safety of a multicomponent, 2-dose Shigella vaccine in preventing shigellosis in African infants.
- Trial name
- NCT06663436
- Testing
- altSonflex1-2-3 Dose A, altSonflex1-2-3 Dose B, altSonflex1-2-3 Dose C
- Where
- Kenya
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Influenza
Feasibility of Cocooning Immunization Strategy With Influenza Vaccine
Influenza causes epidemics of respiratory infection in young children each winter. Young children, particularly those under 6 months of age are most vulnerable to suffering from complications secondary to influenza infection.
- Trial name
- Piiitch (NCT00570037)
- Testing
- Trivalent inactivated influenza vaccine
- Where
- 2 sites in United States
- Volunteers
- 544 people, healthy volunteers welcome
- Sponsor
- Duke University