Status:
COMPLETED
Safety and Immunogenicity of a Booster Vaccination with an Adapted Vaccine
Lead Sponsor:
Hipra Scientific, S.L.U
Conditions:
SARS-CoV2 Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a phase IIb/III, double-blind, randomised, active-controlled, multi-centre, non-inferiority clinical trial that aims to determine safety, tolerability and immunogenicity of a booster vaccinati...
Detailed Description
This is a phase IIb/III, double-blind, randomised, active-controlled, multi-centre, non-inferiority clinical trial that aims to determine safety, tolerability and immunogenicity of a booster vaccinati...
Eligibility Criteria
Inclusion
- Adults aged 18 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 a primary scheme of an EU-approved mRNA vaccine (2 doses) and at least one booster dose with an EU-approved mRNA vaccine. Last booster dose must have been administered at least 6 months before Day 0.
- Having a negative Rapid Antigen Test for COVID-19 at Day 0 prior to vaccination.
- 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.
- Uses an accepted method of contraception
Exclusion
- Participant with an 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
- Participant with a 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.
- Participant with history of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention
- 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
- Participant with a bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
- Have receipt of blood-derived immune globulins, blood, or blood-derived products in the past 3 months
- Participation in other studies involving study intervention if last dose is within 28 days prior to screening and/or it is planned to receive 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
- Received any COVID-19 vaccines other than EU-approved mRNA vaccines
- Received any Omicron XBB adapted vaccine before Day 0
- COVID-19 infection diagnosed in the previous 6 months before Day 0. History of COVID-19 infections is allowed
- History of a diagnosis or other conditions that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2024
Estimated Enrollment :
913 Patients enrolled
Trial Details
Trial ID
NCT06181292
Start Date
November 15 2023
End Date
June 17 2024
Last Update
October 2 2024
Active Locations (10)
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1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital HM Delfos
Barcelona, Barcelona, Spain, 08023
3
CAP Centelles
Centelles, Barcelona, Spain, 08540
4
Hospital Josep Trueta
Girona, Girona, Spain, 17001