Clinical trials: Neuromuscular Diseases in Infants
Spinal Muscular Atrophy
A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy
The primary objective of the study is to examine the clinical efficacy of nusinersen (ISIS 396443) administered intrathecally (IT) to participants with infantile-onset with infantile-onset spinal muscular atrophy (SMA).
- Trial name
- ENDEAR (NCT02193074)
- Testing
- nusinersen
- Where
- 31 sites in United States, Australia and 11 more
- Volunteers
- 122 people
- Sponsor
- Biogen
Cerebral Palsy
Orthosis to Improve Trunk Control in Infants Age 6-18 Months
The purpose of this study is to determine the impact of the SPIO® Core-MAX® Expedition orthosis on an infant's head, trunk and upper limb function.
- Trial name
- NCT06027580
- Testing
- SPIO® Core-MAX® Expedition thoracolumbosacral orthosis, Standard Care Therapy option
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Medical College of Wisconsin
Polio
Comparison of Immunogenicity of Inactivated Poliovirus Vaccine (IPV) Administered Intramuscularly or Intradermally
Polio is an acute transmissible disease caused by any of the three polio virus serotypes (types 1, 2 or 3). In Mozambique, polio vaccination is part of the immunization schedule of the expanded vaccination program.
- Trial name
- NCT04027036
- Testing
- Inactivated poliovirus vaccine in reduced doses
- Where
- 2 sites in Mozambique
- Volunteers
- 382 people, healthy volunteers welcome
- Sponsor
- Instituto Nacional de Saúde, Mozambique
Brain Cancer
Sugammadex Given for the Reversal of Rocuronium Induced Neuromuscular Blockade Under Sevoflurane Anesthesia in Infants
The objective of this study is to evaluate the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in infant patients
- Trial name
- NCT02708056
- Testing
- Sugammadex
- Volunteers
- 26 people
- Sponsor
- Baskent University
Immunity to Polio Vaccines in Malnourished Infants, Immunity to Polio Vaccines in Non-malnourished Infants
IPV in Moderate to Severe Chronic Malnourished 9-12 Month Old Children in Karachi.
Chronic malnutrition is associated with lack of effective gut immunity which is a possible explanation for why we see polio cases among a proportion of children who have received 7 or more doses of OPV.Our proposed idea is to…
- Trial name
- MIPV (NCT01695798)
- Testing
- Injectable polio vaccine and Bivalent oral polio vaccine
- Where
- Pakistan
- Volunteers
- 840 people, healthy volunteers welcome
- Sponsor
- Aga Khan University
Poliomyelitis
Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months
The trial is a phase III, non-inferiority, observer-blind, randomised, controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (reference vaccine)
- Trial name
- VIPV-06 (NCT03032419)
- Testing
- IPV-Al SSI, IPV SSI
- Where
- Philippines
- Volunteers
- 1,002 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Diphtheria, Hepatitis B
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks.
- Conditions
- Diphtheria, Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b
- Trial name
- NCT02853929
- Testing
- Infanrix hexa
- Where
- 29 sites in Australia, Canada and 4 more
- Volunteers
- 551 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B, Polio
Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP~T…
- Conditions
- Hepatitis B, Polio, Diphtheria, Pertussis
- Trial name
- NCT00362336
- Testing
- DTaP-IPV-HB-PRP~T, CombAct-HIB®, Engerix B® Pediatric
- Where
- 2 sites in South Africa
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Diphtheria, Tetanus
Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in…
- Conditions
- Diphtheria, Tetanus, Pertussis, Polio
- Trial name
- NCT01491087
- Testing
- DTacP IPV//PRP~T combined vaccine: PENTAXIM®
- Where
- 3 sites in China
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
HIV Infections
Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
AS PER AMENDMENT 10/24/96: To develop a domain/construct-driven neuropsychological and neurological battery. Scaling of instruments to allow measurement of functions from infancy to early adulthood; establish reliability and…
- Trial name
- NCT00000759
- Where
- United States
- Volunteers
- 675 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Immunity to Oral Rotavirus Vaccine, Immunity to Oral Polio Vaccine
Zinc and/or Probiotic Supplementation of Rotavirus and Oral Polio Virus Vaccines
Background: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries.
- Conditions
- Immunity to Oral Rotavirus Vaccine, Immunity to Oral Polio Vaccine, Shedding of Oral Rotavirus Vaccine
- Trial name
- NCT01616693
- Testing
- Probiotic, Zinc, Rotavirus vaccine
- Where
- India
- Volunteers
- 620 people, healthy volunteers welcome
- Sponsor
- PATH
Poliomyelitis
Lot-consistency Clinical Trial of Sabin Strain Inactivated Polio Vaccine
The purpose of this study is to evaluate the lot consistency, immunogenicity and safety of three lots of Sabin strain inactivated polio vaccine (Vero Cell) (sIPV) manufactured at commercial scale by Sinovac Biotech Co., Ltd., and…
- Trial name
- NCT04386707
- Testing
- Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age, Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age, Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
- Where
- 4 sites in China
- Volunteers
- 1,300 people, healthy volunteers welcome
- Sponsor
- Sinovac Biotech Co., Ltd
Neuromuscular Diseases in Infants, Neuromuscular Diseases in Children
Study of the Correlation Between Muscle Oxygenation and Motor Function in Children With Neuromuscular Disease.
Preliminary data underline the fact that muscular deoxygenation during training happens earlier in adult patients suffering from neuromuscular disorders in comparison to controls. Up to date, pediatric data are lacking.
- Trial name
- OXMNM (NCT03471676)
- Testing
- Muscular oximetry
- Where
- France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Tours
Poliomyelitis
Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants
Study to determine immunogenicity and safety following administration of 2 doses of novel oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or the standard 4-week interval in infants
- Trial name
- NCT05033561
- Testing
- nOPV2
- Where
- 2 sites in Dominican Republic
- Volunteers
- 905 people, healthy volunteers welcome
- Sponsor
- Fidec Corporation
Poliomyelitis
Evaluation of the Immunogenicity and Safety of Concomitant Administration of Novel Oral Polio Type 2 Vaccine and Bivalent Oral Polio Vaccine
The study will assess and compare the immune response and safety following the co-administration of Novel Oral Polio Type 2 (nOPV2) and bivalent Oral Polio Vaccine (bOPV) in comparison with nOPV2 or bOPV in infants aged 2 months…
- Trial name
- NCT05166031
- Testing
- bOPV and nOPV2
- Volunteers
- healthy volunteers welcome
- Sponsor
- Fidec Corporation
Neonatal Brachial Plexus Palsy
Does Wearing Tetra-Grip Improve Arm Function in Children Diagnosed With Neonatal Brachial Plexus Palsy?
This study evaluates the effect of wearing a tetra-grip on the affected arm of children with neonatal brachial plexus palsy. Half of the participants will have tetra-grip applied to the arm, while the other half will not have it…
- Trial name
- NCT03647761
- Testing
- Tetra-grip
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Texas Southwestern Medical Center
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
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Hepatitis B, Tetanus
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity in different population of infants residing in…
- Conditions
- Hepatitis B, Tetanus, Poliomyelitis, Diphtheria
- Trial name
- NCT00753649
- Testing
- Infanrix™ hexa
- Where
- 3 sites in Canada
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Tetanus, Diphtheria
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age
This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination…
- Conditions
- Tetanus, Diphtheria, Haemophilus Influenzae Type b, Poliomyelitis
- Trial name
- NCT00970307
- Testing
- GSK2202083A vaccine, 10-valent pneumococcal vaccine (GSK 1024850A), Infanrix hexa™
- Where
- 9 sites in Poland
- Volunteers
- 421 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline