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

NCT05981846 | Completed Phase 2

• 1 other identifier: HIPRA-HH-11
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 8

Brief Summary

This is a Phase II, randomized, double-blind, multi-centre trial to evaluate the safety and immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen inactivated adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated against COVID-19. In this study approximately 300 adults aged 65 or older will be enrolled and followed for 1 month after study treatment. Safety and immunogenicity of all participants will be assessed.

Conditions

SARS CoV 2 Infection; Influenza, Human

Outcome Measures

Primary Outcomes (4)

• Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.

  Day 0, Day 7

• Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study.

  Day 0, Day 7, Day 28

• Number and percentage of serious adverse events (SAEs) through the end of the study.

  Day 0, Day 7, Day 28

• Number and percentage of adverse events of special interest (AESI) through the end of the study

  Day 0, Day 7, Day 28

Study Arms (3)

BIMERVAX + SIIV

EXPERIMENTAL

Biological: BIMERVAX; Biological: SIIV

BIMERVAX + PLACEBO

ACTIVE COMPARATOR

Biological: BIMERVAX

SIIV + PLACEBO

ACTIVE COMPARATOR

Biological: SIIV

Interventions

BIMERVAX BIOLOGICAL

One dose of booster vaccine

BIMERVAX + PLACEBO; BIMERVAX + SIIV

SIIV BIOLOGICAL

One dose

BIMERVAX + SIIV; SIIV + PLACEBO

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Adults aged 65 or older at Day 0.
• Are willing and able to sign the informed consent and can comply with all study visits and procedures.
• Participant must have received at least a primary scheme of an mRNA vaccine (2 doses). Booster doses or previous COVID-19 infections are allowed. Last dose must have been administered at least 6 months before Day 0. History of COVID-19 infection is allowed if occurred at least \>30 days before Day 0.
• Have a negative Rapid Antigen Test (RAT) at Day 0 before vaccinations.
• Adults determined by clinical assessment, including medical history and clinical judgement, to be eligible for the study, including adults with pre-existing chronic and stable diseases (non-immunocompromised), if these are stable and well-controlled according to the investigator's judgment.

You may not qualify if:

• Acute illness with fever ≥ 38.0°C at Day 0 or within 24 hours prior to vaccination. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
• Allergy to egg proteins (egg or egg products) or chicken proteins.
• History of Guillain-Barré syndrome (GBS)
• History of COVID-19 infection (described as a positive RAT or PCR), in the previous 30 days before Day 0.
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behaviour that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
• Immunocompromised individuals defined as those with primary and secondary immune deficiencies and those receiving chemotherapy or immunosuppressant drugs other than steroids and glucocorticoids (maximum 30mg/day of prednisone, or equivalent, by any administration route for a maximum of 30 consecutive days), within 90 days prior to vaccination or during the study.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months.
• Participation in other studies involving study intervention within 28 days prior to screening and/or during study participation.
• Received any non-study vaccine within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening.
• History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.

Sponsors & Collaborators

• Hipra Scientific, S.L.U: lead

Study Sites (8)

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

CAP Centelles

Centelles, Barcelona, 08540, Spain

Location

Hospital HM Modelo

A Coruña, 15011, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Josep Trueta

Girona, 17001, Spain

Location

Hospital Regional de Málaga

Málaga, 29010, Spain

Location

Hospital Clínico de Valladolid

Valladolid, 47003, Spain

Location

MeSH Terms

Conditions

COVID-19; Influenza, Human

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 8, 2023
• Study Start: September 4, 2023
• Primary Completion: October 9, 2023
• Study Completion: November 6, 2023
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

ES (8)