Status:
UNKNOWN
Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose
Lead Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Collaborating Sponsors:
Instituto de Salud Carlos III
Spanish Clinical Research Network - SCReN
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
CombiVacS is a phase 2 randomized, adaptive trial developed to evaluate the immunogenicity of a dose of COMIRNATY after a previous single dose of VAXZEVRIA. A stratification will be made based on the ...
Detailed Description
This is a randomized, non-blinded, controlled, adaptive, multicenter, Phase II study in subjects aged ≥18 years and in good health or stable clinical situation that have received a previous single dos...
Eligibility Criteria
Inclusion
- Adult subjects (18 years old) having received a prime VAXZEVRIA vaccination between 8 and 12 weeks before the screening visit
- Participants must provide consent indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study.
- Subjects in good health or stable clinical situation.
- Participant is willing and able to adhere to the procedures specified in this protocol.
Exclusion
- Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC within 24 hours prior to the planned dose of study vaccine.
- Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to COMIRNATY excipients.
- Subjects with any contraindication to the administration of COMIRNATY, included pregnancy.
- Subjects with prior documented COVID19 since VAXZEVRIA vaccination.
- Subjects have symptoms or signs compatible with COVID19.
- Subjects participating in a clinical trial in the last three months.
- Any condition or situation precluding or interfering the compliance with the protocol.
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT05378191
Start Date
April 22 2021
End Date
December 30 2022
Last Update
May 18 2022
Active Locations (5)
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1
Hospital Universitario de Cruces
Barakaldo, Bizkaia, Spain, 48903
2
Hospital Vall d´Hebron
Barcelona, Spain, 08035
3
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
4
Hospital Clínico San Carlos
Madrid, Spain, 28040