Influenza Clinical Trial
Official title:
A Phase II Open-Label Study in Healthy Adult and Elderly Populations to Assess the Safety, Reactogenicity, and Immunogenicity of an Intramuscular Unadjuvanted Subvirion Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine
This is a Phase II open-label study in approximately 200, and up to 240, healthy males and non-pregnant females, aged 18 years and older. This study is designed to assess the safety, reactogenicity, and immunogenicity of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufactured by Sanofi Pasteur. Subjects will be stratified by age (approximately 100 (up to 120) subjects 18-64 years old and approximately 100 (up to 120) subjects >/= 65 years old) to receive two doses of vaccine, delivered intramuscularly as 15mcg HA/0.5mL dose, 21 days apart. The duration of the study for each subject will be approximately 7 months.
This is a Phase II open-label study in approximately 200 (up to 240) healthy males and
non-pregnant females, aged 18 years and older. This study is designed to assess the safety,
reactogenicity, and immunogenicity of an unadjuvanted subvirion monovalent inactivated
influenza H3N2 variant (H3N2v) vaccine (MIV) manufactured by Sanofi Pasteur. Subjects will
be stratified by age (approximately 100 (up to 120) subjects 18-64 years old and
approximately 100 (up to 120) subjects >/= 65 years old) to receive two doses of H3N2v MIV,
delivered intramuscularly as 15 micrograms (mcg) of hemagglutinin (HA)/0.5 milliliter (mL)
dose, 21 days apart (see Table 1). Subjects may receive licensed seasonal influenza vaccine
prior to (2 weeks if given the inactivated vaccine or 4 weeks if given the live, attenuated
vaccine) the first H3N2v vaccination. Alternatively, subjects may receive licensed seasonal
influenza vaccine at any time after completion of the Day 42 visit or following an early
termination visit. Safety will be measured by the occurrence of solicited injection site and
systemic reactogenicity on the day of each H3N2v vaccination through 7 days after each H3N2v
vaccination, adverse events through 42 days after the first H3N2v vaccination, and serious
adverse events (SAEs) and new-onset chronic medical conditions through 7 months after the
first H3N2v vaccination. Immunogenicity testing will include performing hemagglutination
inhibition (HAI) and neutralizing (Neut) antibody assays on serum obtained on the day of and
prior to each H3N2v vaccination (Days 0 and 21), approximately 8 days after each H3N2v
vaccination (Days 8 and 29), and approximately 21 days after the second H3N2v vaccination
(Day 42).
From a subset of healthy adult subjects (up to 30 volunteers 18-64 years old enrolled at the
Emory VTEU site who consent to blood donation for the immunology exploratory assays), an
additional volume of venous blood will be drawn on Days 0, 8, 21, 29 and 42 to determine the
specificity/cross reactivity of antibodies from H3N2v-reactive B cells with other influenza
subtypes (e.g., 2009 H1N1 pandemic HA) and most recent H3 seasonal HA to define the
molecular profile of antibody repertoire changes in circulating B cells after H3N2v
vaccination, and to characterize the antibody-secreting cell (ASC), monoclonal antibody
(mAb), and CD4+ T cell responses to H3N2v vaccination. The duration of the study for each
subject will be approximately 7 months. Parent protocol to sub-study 12-0089 and 12-0015.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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