Respiratory Tract Infections Clinical Trial
Official title:
A Phase 1, Randomized, Observer-Blind, Multi-Center, Dose Ranging Study to Evaluate the Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted or Non-Adjuvanted Cell Culture-derived A/H2N3 Subunit Influenza Virus Vaccine in Healthy Subjects 18 Years and Above
This Phase 1, randomized, observer-blind, dose-ranging clinical study is evaluating 6 different formulations of MF59-adjuvanted and non-adjuvanted H2N3 influenza vaccine. Approximately 600 healthy adult subjects are to be randomized into 1 of 6 possible treatment groups with 100 subjects per group, stratified by age group (born after or before 1968). Each subject will receive an influenza vaccine injection on Day 1 and Day 22. Subjects will be followed up for approximately 12 months after the second vaccine injection. The primary immunogenicity analysis is based on the Day 1, Day 8, Day 22, Day 29, and Day 43 serology data. The primary safety analysis is based on solicited local and systemic adverse events (AEs) reported within 10 days after each vaccination, unsolicited AEs reported within 3 weeks after each vaccination, and serious AEs (SAEs), medically attended AEs (MAAEs), AEs leading to withdrawal from the study, and AEs of special interest (AESIs) reported throughout the study.
n/a
| 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 | |
| Active, not recruiting |
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 |