Influenza, Human Clinical Trial
Official title:
A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of a MF59-Adjuvanted Quadrivalent Subunit Cell-derived Influenza Vaccine (aQIVc) in Comparison With Quadrivalent Influenza Vaccines, in Adults Aged 50 Years and Older.
This is a Phase 3, randomized, parallel-group, comparator-controlled, observer-blind, multicenter study of immunogenicity and safety in approximately 7700 male and female adults aged 50 years and older (approximately equally split between two age groups: 50-64 years; 65 years and older), who are healthy or have stable comorbidities that increase their risk of complications from influenza infection. Three lots of aQIVc will be evaluated for consistency and pooled for the comparison with the 2 control vaccines. Subjects will be randomly assigned to receive 1 of 3 lots of aQIVc, QIV1, or QIV2 in a 1:1:1:2:2 ratio (for a 3:2:2 ratio for aQIVc, QIV1, and QIV2). The study will have a treatment period (Day 1 to Day 29) and a follow-up period (Day 30 up to Day 181); a subset of 770 subjects will be followed up up to Day 365.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
| Completed |
NCT03275389 -
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
|
Phase 1 | |
| Completed |
NCT05981846 -
A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19
|
Phase 2 | |
| Completed |
NCT05044195 -
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
|
Phase 3 | |
| Completed |
NCT02914275 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
|
Phase 3 | |
| Completed |
NCT04590066 -
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy
|
N/A | |
| Recruiting |
NCT03778203 -
Development of Childhood Anti-influenza Immunity
|
Phase 4 | |
| Completed |
NCT04527614 -
Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
|
N/A | |
| Terminated |
NCT03658629 -
Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults
|
Phase 2 | |
| Completed |
NCT05269290 -
Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections
|
Phase 3 | |
| Completed |
NCT06385821 -
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
|
Phase 3 | |
| Completed |
NCT02867358 -
A Clinical Trial of KT07 Capsule in the U.S.A
|
Phase 2 | |
| Completed |
NCT02998996 -
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
|
Phase 1/Phase 2 | |
| Completed |
NCT02984280 -
Specific Respiratory Infections as Triggers of Acute Medical Events
|
N/A | |
| Withdrawn |
NCT02883972 -
Childhood Influenza Immunisation Invitation Trial in Schools
|
N/A | |
| Completed |
NCT02545543 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
|
Phase 3 | |
| Completed |
NCT02621164 -
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents
|
Phase 3 | |
| Completed |
NCT02212106 -
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
|
Phase 4 | |
| Completed |
NCT02243774 -
Mail Outreach To Increase Vaccination Acceptance Through Engagement
|
N/A | |
| Completed |
NCT02344134 -
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects
|
Phase 3 |