Study of Influenza Vaccines Containing an Additional H3 Antigen in Healthy Adult Participants 18 to 49 Years of Age and 60 Years of Age and Older
NCT Number: NCT06507553
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Influenza|Healthy Volunteers
Interventions: BIOLOGICAL: Trivalent-Darwin influenza vaccine|BIOLOGICAL: Augment-Tasmania influenza vaccine|BIOLOGICAL: TIV-2X Darwin influenza vaccine|BIOLOGICAL: Trivalent-Tasmania influenza vaccine
Sponsor: Sanofi Pasteur, a Sanofi Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-12
Completion Date: 2025-07-04

Summary:
Study FBP00005 is planned to be a translational Phase I, randomized, modified double-blind, active-controlled, multi-center study to be conducted in 2 stages in approximately 400 adults, 18 to 49 years of age and ≥ 60 years of age, in Australia. The purpose of the study is to evaluate the safety and immunogenicity of an influenza vaccine formulation composed of the WHO-recommended virus strains plus an additional H3 strain, compared to formulations containing a single strain from each influenza virus subtype.

Younger adults 18 to 49 years of age will be enrolled in Stage 1 and offered study vaccine formulations at the standard dose. Adults ≥ 60 years of age in Stage 2 will be offered study vaccine formulations at a higher dose.

Enrollment of participants in Stage 2 will occur after review of, and be guided by, safety and immunogenicity results from Stage 1. The study duration will be approximately 3 weeks.

Primary Outcome Measures: Number of participants with immediate adverse event, Includes unsolicited systemic adverse events (or) medically relevant unsolicited systemic adverse events, including those related to the product administered, Within 30 minutes after vaccination|Number of participants with solicited injection site reactions, Adverse reactions prelisted in the participant diary, Within 7 days after vaccination|Number of participants with solicited systemic reactions, Adverse reactions prelisted in the participant diary, Within 7 days after vaccination|Number of participants with unsolicited adverse events, Adverse events other than solicited reactions, Throughout the study, approximately 3 weeks|Number of participants with serious adverse events, SAEs occurring throughout the study, Throughout the study, approximately 3 weeks|Number of participants with adverse events of special interest (AESIs), AESIs occurring throughout the study, Throughout the study, approximately 3 weeks
Secondary Outcome Measures: Seroconversion based on hemagglutination inhibition antibody titer, Seroconversion (HAI Ab titer \< 10 \[1/dilution\] at day 1 and post-injection titer ≥ 40 \[1/dilution\] at day 22, or titer ≥ 10 \[1/dilution\] at day 1 and a ≥ 4-fold increase in titer \[1/dilution\] at day 22), Day 1 and day 22|Seroprotection based on hemagglutination inhibition antibody titer, Seroprotection (HAI Ab titer ≥ 40 \[1/dilution\]), Day 1 and day 22|Obtained hemagglutination inhibition antibody titers, Assessment of hemagglutination inhibition (HAI) antibody (Ab) titers obtained on day 1 and day 22 after vaccination, Day 1 and day 22|Obtained virus neutralization antibody titers, Assessment of virus neutralization (VN) antibody (Ab) titers obtained on day 1 and day 22 after vaccination, Day 1 and day 22|Individual hemagglutination inhibition titers ratio, Seroconversion (HAI Ab titer \< 10 \[1/dilution\] at day 1 and post-injection titer ≥ 40 \[1/dilution\] at day 22, or titer ≥ 10 \[1/dilution\] at day 1 and a ≥ 4-fold increase in titer \[1/dilution\] at day 22), Day 1 and day 22|Individual virus neutralization titers ratio, Individual VN titers ratio (day 22/ day 1), Day 1 and day 22|2-fold rise in virus neutralization titers, From day 1 to day 22|4-fold rise in virus neutralization titers, From day 1 to day 22