COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04860739

Jesús Frías Iniesta

Not reported

2021-04-27

Not recruiting

RCT

Randomized

Parallel

Open label

multi-center

Prevention

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

- 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.

2

Spanish Clinical Research Network - SCReN

18

60

Spain

Healthy volunteers

N/A

676

To assess the humoral immune response against SARS-CoV-2, 14 days after a vaccination with COMIRNATY in subjects that received a previous single dose of VAXZEVRIA, as compared with no dosing.

None

Phase 2

[{"arm_notes": "1;Day14;having received prior ChAdOx1 nCoV-19 vaccine (heterogeneous prime-boost)", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "If primary analysis at day 14th confirms the starting hypothesis subjects randomized to this arm will be considered for administration of one dose of BNT162b2 at day 28", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]