Clinical Trials Logo
  1. Home
  2. Influenza, Human
  3. NCT05470582

Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

Influenza, Human Clinical Trial

Official title:
Randomized, Double-blind, Comparative, Controlled Trial of Tolerability, Safety and Immunogenicity of the Flu-M Vaccine in Children Between 6 Months and 9 Years Old

Clinical Trial Summary

Comparative trial of tolerability, reactogenicity, safety and immunogenicity of the Flu-M vaccine as compared to the Vaxigrip® vaccine in terms of prevention of influenza in children aged 6 months to 9 years (at the time of the first vaccination).

Clinical Trial Description

The trial includes 2 stages (stage I, II). At stage I children aged 3-9 years will be included. Based on findings from tolerability and safety assessment in respect of the Flu-M vaccine vs. the Vaxigrip® vaccine for the first 7 days after vaccination of volunteers during Stage I, an intermediate report will be prepared. The report will be submitted to the supervisory executive authorities alongside the notice of commencement of Stage II of the trial - the continuation of trial on children aged 3-9 years and the commencement of trial on children aged between 6 months and 35 months. During Stage II, the trial for Stage I volunteers will continue in full and also children aged between 6 and 35 months will be included in the trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05470582
Study type Interventional
Source St. Petersburg Research Institute of Vaccines and Sera
Contact
Status Completed
Phase Phase 3
Start date February 16, 2021
Completion date December 24, 2021
View Details
See also
  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
Withdrawn NCT02883972 - Childhood Influenza Immunisation Invitation Trial in Schools N/A
Completed NCT02984280 - Specific Respiratory Infections as Triggers of Acute Medical Events N/A
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 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 NCT02243774 - Mail Outreach To Increase Vaccination Acceptance Through Engagement N/A
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 NCT02621164 - Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents Phase 3
Completed NCT02344134 - Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects Phase 3