Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose

• Status: Active, not recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

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 following factors: study site, sex and age. This protocol allows to test the immunogenicity and safety of a heterologous vaccination strategy after a previous single dose of VAXZEVRIA.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Spanish Clinical Research Network - SCReN
• Collaborator: Instituto de Salud Carlos III
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.