Respiratory Tract Infections Clinical Trial
Official title:
Safety, Tolerability and Immunogenicity of a Plant-made H7 Virus-like Particle (VLP) Influenza Vaccine in Adults.
A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2 intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy adults, 18-60 years of age.
This study will consist of a dose-ranging in one hundred (100) subjects who will be randomized in parallel to a 1:1:1:1:1 ratio in five (5) groups of 20 subjects to receive one intramuscular injection at Days 0 and 21 of either a low, medium or high dose of H7 VLP vaccine mixed with Alhydrogel® 0.4% (0.5 mg Aluminum per dose) or a high dose of H7 VLP alone or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80). Twenty-one (21) days after each immunization, key safety and immunogenicity data will be collected and analysed. All subjects will be followed for safety until Day 228. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
| Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
| Terminated |
NCT04583280 -
A Study of Rilematovir in Infants and Children and Subsequently in Neonates Hospitalized With Acute Respiratory Tract Infection Due to Respiratory Syncytial Virus (RSV)
|
Phase 3 | |
| Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
| Active, not recruiting |
NCT03251196 -
TB Sequel: Pathogenesis and Risk Factors of Long-term Sequelae of Pulmonary TB
|
||
| Completed |
NCT02561871 -
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers
|
Phase 1 | |
| Terminated |
NCT02032056 -
Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period
|
N/A | |
| Completed |
NCT01911143 -
A Retrospective, Blinded Validation of a Host-response Based Diagnostics
|
N/A | |
| Completed |
NCT01419262 -
DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers
|
Phase 3 | |
| Terminated |
NCT01432080 -
Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant
|
Phase 2 | |
| Completed |
NCT00984945 -
Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults
|
Phase 1 | |
| Completed |
NCT00127686 -
Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep
|
Phase 1 | |
| Active, not recruiting |
NCT01107223 -
Long Term Effect of General Practitioner Education on Antibiotic Prescribing
|
N/A | |
| Completed |
NCT03739112 -
Efficacy of a Plant-derived Quadrivalent Virus-like Particle (VLP) Vaccine in the Elderly
|
Phase 3 | |
| Completed |
NCT04144491 -
Effect of L. Rhamnosus Yoba on RTI and Other Health Outcomes Among Children (3-6 Years) in Uganda
|
N/A | |
| Completed |
NCT05318235 -
Virus Interactions in the Respiratory Tract; a Cohort Study With Children
|
||
| Active, not recruiting |
NCT04170348 -
Daily Vitamin D for Sickle-cell Respiratory Complications
|
Phase 2 | |
| Completed |
NCT04525040 -
ProbioKid as Prevention Among Kids With Frequent URTI
|
N/A | |
| Completed |
NCT05535777 -
Patient Portal Flu Vaccine Reminders_RCT 5 (LADHS)
|
N/A | |
| Not yet recruiting |
NCT05914324 -
Outpatient Pediatric Pulse Oximeters in Africa
|
N/A |