Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults = 65 Years of Age

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02587221
• Date of registration: 15/10/2015
• Prospective Registration: Yes
• Primary sponsor: Seqirus
• Public title: Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults = 65 Years of Age
• Scientific title: A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults = 65 Years of Age
• Date of first enrolment: September 30, 2016
• Target sample size: 6790
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02587221
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Colombia, Czech Republic, Czechia, Estonia, Latvia, Lithuania, Malaysia, Philippines, Poland, Romania, Thailand, Turkey

Contacts

• Name: Clinical Program Manager
• Affiliation: Seqirus

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Males and females = 65 years old who are healthy or have co-morbidities

2. Individuals who or whose legal guardian have voluntarily given written consent after
the nature of the study has been explained according to local regulatory requirements,
prior to study entry.

3. Ability to attend all scheduled visits and to comply with study procedures

Exclusion Criteria:

1. Hypersensitivity, including allergy to any component of vaccines foreseen in this
study

2. Abnormal function of the immune system.

3. Receipt of any influenza vaccine within 6 months prior to enrolment in this study or
who plan to receive influenza vaccine while participating in the study.

4. Additional eligibility criteria may be discussed by contacting the site



Age minimum: 65 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)

Biological: Non-Influenza Comparator (Boostrix)

Primary Outcome(s)

Safety Endpoint: Percentages of Subjects With Any Unsolicited AE [Time Frame: Day 1 through Day 366]

Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Protocol Defined ILI Definition. [Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer]

Safety Endpoint: Percentages of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), and Adverse Events of Special Interest (AESI) [Time Frame: Day 1 to Day 366]

Safety Endpoint: Percentage of Subjects With Medically-attended Adverse Events (MAAEs) [Time Frame: Within 30 days after of first occurrence RT-PCR confirmed Influenza]

Safety Endpoint: The Percentage of Subjects in the Solicited Safety Subset With Solicited Local and Systemic Adverse Events (AE) [Time Frame: Day 1 through Day 7]

Secondary Outcome(s)

Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition. [Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer]

Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition. [Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer]

Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Modified CDC ILI Definition. [Time Frame: Day 7 to Day 180 after vaccination or end of influenza season, whichever is longer]

Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Matched to the Strains Selected for the Seasonal Vaccine Using Protocol Defined ILI Definition. [Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer]

Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on RT-PCR-confirmed Influenza Due to Any Strain Using Modified CDC ILI Definition. [Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer]

Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Antigenically Unmatched to the Strains Selected for the Seasonal Vaccine Using Modified CDC ILI Definition. [Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer]

Immunogenicity Endpoint: Geometric Mean Ratio (GMR) of Post-vaccination HI Titer Over the Pre-vaccination HI Titer [Time Frame: Day 22/Day 1]

Immunogenicity Endpoint: Percentages of Subjects With an HI Titer =1:40 [Time Frame: Day 22]

Absolute Vaccine Efficacy (VE) of aQIV Versus Non-influenza Comparator Based on Culture Confirmed Influenza Due to Any Strain of Influenza Regardless of Antigenic Match Using Protocol Defined ILI Definition. [Time Frame: Day 21 to Day 180 after vaccination or end of influenza season, whichever is longer]

Immunogenicity Endpoint: Geometric Mean Hemagglutination Inhibition (HI) Titers (GMT) [Time Frame: Days 1 and 22]

Immunogenicity Endpoint: Percentages of Subjects Who Achieved Seroconversion (SCR) [Time Frame: Day 22]

Secondary ID(s)

V118_18

2015-000728-27

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 09/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02587221