Overview

Vaccination With COMIRNATY in Subjects With a VAXZEVRIA First Dose

Status:
Active, not recruiting
Trial end date:
2022-12-30
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:
Instituto de Investigación Hospital Universitario La Paz
Collaborators:
Instituto de Salud Carlos III
Spanish Clinical Research Network - SCReN
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.