A Phase 2, Comparative, Randomised, Adaptive Trial to Evaluate the safety and immunogenicity of one dose of COMIRNATY in subjects that had received one dose of VAXZEVRIA.
- Conditions
- Therapeutic area: Diseases [C] - Virus Diseases [C02]Covid-19 Vaccination
- Registration Number
- EUCTR2021-001978-37-ES
- Lead Sponsor
- Instituto de Salud Carlos III. ISCIII
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 600
1. Adult subjects (18 years old) having received a previous single dose of VAXZEVRIA vaccination between 8 and 12 weeks before the screening visit.
2. Subjects in good health or stable clinical situation.
3. Subject providing informed consent to participate in the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300
1. 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.
2. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to COMINARTY excipients.
3. Subjects have symptoms or signs compatible with COVID19
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method