Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT02022163
Study type Interventional
Source Medicago
Contact
Status Completed
Phase Phase 1
Start date December 2013
Completion date December 2014

See also
  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
Completed NCT01911143 - A Retrospective, Blinded Validation of a Host-response Based Diagnostics N/A
Terminated NCT02032056 - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period N/A
Terminated NCT01432080 - Steroids, Azithromycin, Montelukast, and Symbicort (SAMS) for Viral Respiratory Tract Infection Post Allotransplant Phase 2
Completed NCT01419262 - DO IT Trial: Vitamin D Outcomes and Interventions In Toddlers Phase 3
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