Status:
WITHDRAWN
COVID-19 Paediatric VLA2001-321 Study
Lead Sponsor:
Valneva Austria GmbH
Conditions:
SARS-CoV-2 Infection
Eligibility:
All Genders
2-12 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a Randomized, Double-blinded, Active-controlled Study to evaluate the Safety, Tolerability and Immunogenicity of VLA2001 in participants of ≥2 to 12 years. In total 1720 participants will rec...
Detailed Description
This is a Randomized, Double-blinded, Active-controlled Study to evaluate the Safety, Tolerability and Immunogenicity of VLA2001 in participants of ≥2 to 12 years. The study will consist of four part...
Eligibility Criteria
Inclusion
- Written informed consent by the participant's legal representative(s), according to local requirements, and written informed assent of the participant, if applicable, prior to any study related procedures.
- Participants of either gender aged between 2 years and \<12 years at screening.
- Regarding history of Menactra (meningococcal vaccination): only participants \<5 years can be included who received no Menactra vaccination. Participants ≥5 years can be included, if at least 4 years have elapsed since the prior dose.
- Medically stable such that, according to the judgment of the investigator the participant appears likely to be able to remain on study through the end of protocol-specified follow-up.
- • For participants with chronic diseases (such as, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus \[HIV\] infection), the disease should be stable, defined as not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to the expected day of randomization (Visit 1) and as per investigator assessment.
- Must be able to attend all visits of the study and comply with all study procedures, including daily completion of the e-Diary after each vaccination.
- Female participants of non-childbearing potential may be enrolled. For this study, non-childbearing potential is defined as pre-menarche.
- Female participants of childbearing potential (WOCBP) might be enrolled if:
- have a negative pregnancy test on the day of vaccination,
- have practiced adequate contraception\* or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection,
- have agreed to continue adequate contraception or abstinence through 3 months following the second injection (Phase 2 part) or following the third vaccination (Phase 3 part),
- are not currently breastfeeding.
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 or its excipients.
- Prior history of allergic or anaphylactic reaction after previous dose of a meningococcal capsular 12 polysaccharide-, diphtheria toxoid- or CRM197-containing vaccine, or to any component of Menactra.
- Significant infection (e.g., positive SARS-CoV-2 RT-PCR) or other acute illness, including fever \>100.4 °F (\>38.0 °C) within 2 weeks prior to administration of vaccine.
- A medical or psychiatric condition that, according to the investigator's judgment, may pose additional risk as a result of participation, interfere with study assessments, interfere with interpretation of results or compromise participant safety.
- Participants with history of multisystemic-inflammatory syndrome in children (MIS-C).
- Participated in an interventional clinical study within 28 days prior to Day 1.
- Received any non-study vaccine within 28 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is permitted within 14 days before or after any dose of vaccine).
- Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection.
- Severe and uncontrolled ongoing autoimmune or inflammatory disease, history of Guillain-Barre syndrome, or any other demyelinating condition
- 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,
- Immunosuppressive treatment during the course of the study (unless such treatment has to be administered in an emergency situation). Note: Specifically, treatment that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (\>800 μg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs. Use of inhaled (low dose), intranasal or topical steroids is permitted
- Glucocorticoids at a dose ≥20 mg/day of prednisone or equivalent given daily or on alternate days for ≥14 consecutive days between randomization and the participant´s schedule
- Other systemically administered drugs with significant immunosuppressive activity, such as azathioprine, tacrolimus, cyclosporine, methotrexate, or cytotoxic chemotherapy between randomization and the participant´s schedule
- Prior administration of an investigational or approved CoV vaccine (such as, SARS-CoV-2, SARS CoV, Middle East Respiratory Syndrome CoV) or planned use during the trial.
- Treatment with investigational or approved agents for prophylaxis against COVID 19 (such as, receipt of SARS-CoV-2 monoclonal antibodies or oral COVID 19 anti-viral agents) within 6 months prior to enrolment.
- Receipt of any vaccine (licensed or investigational), other than licensed influenza vaccine, within 28 days prior to the expected day of randomization (Visit 1).
- Others:
- Any member of the study team or sponsor.
- An immediate family member or household member of the study's personnel.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05298644
Start Date
October 1 2022
End Date
August 30 2025
Last Update
November 8 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.