COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04864561

Not reported

Not reported

2021-04-29

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: 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.

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

4

Valneva Austria GmbH

12

100

United Kingdom

Healthy volunteers

N/A

4034

Frequency and severity of any Adverse Events (AE);Immune response measured after completion of a 2-dose immunization schedule, as determined by Seroconversion in adults and adolescents (definded as 4-fold increase from baseline) of SARS-CoV-2-specific neutralizing antibodies;Immune response measured after completion of a 2-dose immunization schedule, as determined by the geometric mean titer (GMT) ratio in adults and GMT in adolescents of SARS-CoV-2-specific neutralizing antibodies

None

Phase 3

[{"arm_notes": "2;Days0-28; <30 years will receive VLA2001; participants aged >=30 years will be randomised 2:1 to receive VLA2001 or AZD1222", "treatment_id": 1375, "treatment_name": "Vla2001", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2;Days0-28; <30 years will receive VLA2001; participants aged >=30 years will be randomised 2:1 to receive VLA2001 or AZD1222", "treatment_id": 161, "treatment_name": "Chadox1 ncov-19", "treatment_type": "Non replicating viral vector", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2+1;Days0-28+day208; \u226512 to < 18 years will be randomized 1:1 to receive VLA2001 or Placebo", "treatment_id": 1375, "treatment_name": "Vla2001", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]