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

February 23, 2024 updated by: Hipra Scientific, S.L.U

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

279

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adults aged 65 or older at Day 0.
  2. Are willing and able to sign the informed consent and can comply with all study visits and procedures.
  3. 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.
  4. Have a negative Rapid Antigen Test (RAT) at Day 0 before vaccinations.

  5. 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.

    Exclusion Criteria:

  6. 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.
  7. Allergy to egg proteins (egg or egg products) or chicken proteins.
  8. History of Guillain-Barré syndrome (GBS)
  9. History of COVID-19 infection (described as a positive RAT or PCR), in the previous 30 days before Day 0.
  10. 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.
  11. 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).
  12. 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.
  13. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  14. Receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months.
  15. Participation in other studies involving study intervention within 28 days prior to screening and/or during study participation.
  16. Received any non-study vaccine within 14 days before or after screening. For live or attenuated vaccines, 4 weeks before or after screening.
  17. History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIMERVAX + SIIV
Biological: BIMERVAX
One dose of booster vaccine
Biological: SIIV
One dose
Active Comparator: BIMERVAX + PLACEBO
Biological: BIMERVAX
One dose of booster vaccine
Active Comparator: SIIV + PLACEBO
Biological: SIIV
One dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number, percentage, and characteristics of solicited local and systemic reactions through Day 7 after vaccination.
Time Frame: Day 0, Day 7
Day 0, Day 7
Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through the end of the study.
Time Frame: Day 0, Day 7, Day 28
Day 0, Day 7, Day 28
Number and percentage of serious adverse events (SAEs) through the end of the study.
Time Frame: Day 0, Day 7, Day 28
Day 0, Day 7, Day 28
Number and percentage of adverse events of special interest (AESI) through the end of the study
Time Frame: Day 0, Day 7, Day 28
Day 0, Day 7, Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hipra Scientific, S.L.U

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Actual)

October 9, 2023

Study Completion (Actual)

November 6, 2023

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

August 7, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 26, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIPRA-HH-11

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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