Status:
COMPLETED
COV-COMPARE Immunogenicity of Vaccine VLA2001 Compared to AZD1222
Lead Sponsor:
Valneva Austria GmbH
Conditions:
SARS-CoV-2 Virus Infection
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This is a multicentre, randomized, observer-blind, active-controlled, superiority, study in adults to compare the immunogenicity of VLA2001 to AZD1222 in terms of GMT of SARS-CoV-2-specific neutralisi...
Detailed Description
Approximately 4000 Adult participants will be recruited in the study. About 3000 participants aged 30 years and above will be randomized in a 2:1 ratio to receive 2 intramuscular recommended doses of ...
Eligibility Criteria
Inclusion
- Participants must have read, understood, and signed the informed consent form (ICF).
- Participants of either gender aged 12 years and older at screening.
- Medically stable
- Must be able to attend all visits of the study and comply with all study procedures,
- Women of childbearing potential (WOCBP) must be able and willing to use at least 1 highly effective method of contraception for a minimum of 3 months after the last dose of study vaccine.
- WOCBPs must have a negative pregnancy test prior to each vaccination.
Exclusion
- Participant is pregnant or planning to become pregnant within 3 months after study vaccine administration.
- History of allergy to any component of the vaccine.
- Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness, including fever \> 100 °F (\> 37.8 °C) 48 hours before vaccination.
- Participant has a known or suspected defect of the immune system
- Participant has a history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
- Participant has a history of malignancy in the past 5 years other than squamous cell or basal cell skin cancer. If there has been surgical excision or treatment more than 5 years ago that is considered to have achieved a cure, the participant may be enrolled. A history of hematologic malignancy is a permanent exclusion. Participants with a history of skin cancer must not be vaccinated at the previous tumour site.
- History of drug dependency or current use of drug of abuse or alcohol abuse at screening.
- Significant blood loss (\> 450 mL) or has donated 1 or more units of blood or plasma within 6 weeks prior to the expected day of randomization (Visit 1).
- History of clinically significant bleeding disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture.
- Severe and uncontrolled ongoing autoimmune or inflammatory disease History of Guillain-Barre syndrome or any other demyelinating condition.
- Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the volunteer
- Prior/concomitant therapy:
- Receipt of immunoglobulin or another blood product within the 3 months before expected day of randomization (visit 1) in this study or those who expect to receive immunoglobulin or another blood product during this study.
- Receipt of medications and or vaccinations intended to prevent COVID-19.
- Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (Visit 1).
- Any member of the study team or sponsor.
- An immediate family member or household member of the study's personnel.
- Booster Vaccination (Adults and Adolescents)
- In addition to the above-described eligibility criteria, the following criteria must be met:
- 1\. Participant has not received another licensed COVID-19 vaccine during the study
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2023
Estimated Enrollment :
4034 Patients enrolled
Trial Details
Trial ID
NCT04864561
Start Date
April 26 2021
End Date
March 13 2023
Last Update
March 20 2023
Active Locations (31)
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1
Barnsley Hospital NHS FT
Barnsley, United Kingdom, S75 2EP
2
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2WB
3
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom, FY3 8NR
4
North Bristol NHS Trust
Bristol, United Kingdom, BS10 5NB