H3N2 M2SR in Pediatric Population
Condition: Influenza; Influenza Immunisation
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I double-blind, randomized, placebo-controlled study in 50 healthy
      adolescents and children, 9-17 years of age, inclusive, who are in good health and meet all
      eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity
      of a prime-boost regimen of H3N2 M2SR intranasal influenza vaccine (manufactured by FluGen)
      followed by licensed inactivated Quadrivalent Influenza Vaccine (QIV) boost administered
      intramuscularly Subjects will be enrolled in one of two groups in a 1:1 ratio. Arm 1 will
      receive one dose of M2SR intranasally on Day 1 and one dose of QIV on Day 92. Arm 2 will
      receive one dose of placebo (saline) intranasally on Day 1, and one dose of QIV on Day 92.
      Study duration will be approximately 28 months with patient participation duration
      approximately 13 months. The primary study objective is to assess the safety and
      reactogenicity of a monovalent live attenuated influenza H3N2 M2SR vaccine.
    

Detailed description: 
      This is a Phase I double-blind, randomized, placebo-controlled study in 50 healthy
      adolescents and children, 9-17 years of age, inclusive, who are in good health and meet all
      eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity
      of a prime-boost regimen of H3N2 M2SR intranasal influenza vaccine (manufactured by FluGen)
      followed by licensed inactivated Quadrivalent Influenza Vaccine (QIV) boost administered
      intramuscularly. Subjects will be enrolled in one of two groups in a 1:1 ratio. Arm 1 will
      receive one dose of M2SR intranasally on Day 1 and one dose of QIV on Day 92. Arm 2 will
      receive one dose of placebo (saline) intranasally on Day 1, and one dose of QIV on Day 92.
      Study duration will be approximately 28 months with patient participation duration
      approximately 13 months. The primary study objective is to assess the safety and
      reactogenicity of a monovalent live attenuated influenza H3N2 M2SR vaccine. The secondary
      study objectives are to identify circulating and mucosal antibody responses induced by H3N2
      M2SR vaccination and to identify cellular immune responses induced by H3N2 M2SR vaccination.
    

Intervention name(s): Influenza Virus Monovalent A/H3N2/Bris 10 M2SR Live Vaccine; Placebo; Quadrivalent MDCK Inactivated Influenza Vaccine
Intervention type(s): Biological; Other; Biological
Intervention description(s): Live monovalent influenza A/H3N2-based M2SR (M2 defective Single Replication vaccine), comprised of 5 out of 8 gene segments on the donor virus influenza A/Puerto Rica/8/34. HA and NA derive from an A/Brisbane/10/2007-like virus. Administered intranasally as s single dose.; H3N2 M2SR vaccine placebo (normal saline). Administered intranasally as a single dose.; A quadrivalent cell culture inactivated vaccine (ccIV4) is an inactivated subunit influenza vaccine prepared from virus propagated in Madin Darby Canine Kidney (MDCK) cells indicated for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. Administered intramuscularly as a single dose.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: H3N2 M2SR Prime; Immunogenicity; Influenza; Pediatric Population; QIV; Safety; Vaccine