SARS-CoV-2 InfectionPhase 2/3NCT05298644
COVID-19 Paediatric VLA2001-321 Study
A Phase 2/3 study testing VLA2001 and Active Comparator in people with SARS-CoV-2 Infection, run by Valneva Austria GmbH.
Trial 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 receive either VLA2001 or active Comparator. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- VLA2001 and Active Comparator
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 30 Aug 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Show all 21Show fewer
- 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.
About this study
Official title: A Randomized, Double-Blinded, Active Controlled COVID-19 Study to Evaluate The Safety, Tolerability, And Immunogenicity Of Different Doses Of VLA2001 Vaccine, In Children (≥2 To <12 Years)
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 receive either VLA2001 or active Comparator.
Read the 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 parts:
- Dose-finding part (participants aged ≥5 to <12 years)
- Dose-finding part (participants aged ≥2 to <5 years)
- Confirmatory part (participants aged ≥5 to <12 years)
- Confirmatory part (participants aged ≥2 to <5 years)
Dose-finding part (participants aged ≥5 to <12 years) Approximately 60 participants will receive 2 intramuscular doses of either half-dose VLA2001 (n=30) or full-dose VLA2001 (n=30) on Days 1 and 29 in a 1:1 ratio.
Dose-finding part (participants aged ≥2 to <5 years) Approximately 60 participants will receive 2 intramuscular doses of either half-dose VLA2001 (n=30) or full-dose VLA2001 (n=30) on Days 1 and 29 in a 1:1 ratio.
Dose-finding part for age group ≥2 to <5 years will be initiated after dose for age group ≥5 to <12 years is confirmed.
Confirmatory Part (participants aged ≥5 to <12 years and ≥2 to <5 years) Overall, approximately 1600 participants aged ≥2 to <12 years will be enrolled. 800 participants aged ≥5 to <12 years and 800 participants aged ≥2 to <5 years will be randomized in 3:1 ratio. In each age group, 600 participants will receive VLA2001, and 200 participants comparator.
Vaccination will start with either 1 intramuscular dose of VLA2001 (selected dose) or comparator vaccine. 28 days later all participants will receive a dose of VLA2001 (selected dose) and 28 days thereafter those who had received the comparator vaccine will receive their second dose with VLA2001 while those who have already received two doses of VLA2001 will receive the comparator vaccine.
- Conditions
- SARS-CoV-2 Infection
- Being tested
- VLA2001, Active Comparator
- Keywords
- VLA2001, SARS-CoV-2 Infection, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLA2001Biological
whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG)1018 in combination with aluminium hydroxide
Active ComparatorDrug
Menactra, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine.
| Study group | Role | What they receive |
|---|---|---|
| Dose finding ≥5 to <12 years | Experimental | on Day 1 and Day 29 either VLA2001 half dose or VLA2001 full dose Receives: Biological: VLA2001 |
| Dose finding ≥2 to <5 years | Experimental | on Day 1 and Day 29 either VLA2001 half dose or VLA2001 full dose Receives: Biological: VLA2001 |
| Confirmatory ≥5 to <12 years | Other | Day 1: VLA2001 selected dose (= either VLA2001 half dose or VLA2001 full dose) Day 29: VLA2001 selected dose (= either VLA2001 half dose or VLA2001 full dose) Day 57: Active Comparator Receives: Biological: VLA2001; Drug: Active Comparator |
| Confirmatory ≥2 to <5 years | Other | Day 1: Active Comparator Day 29: VLA2001 selected dose (= either VLA2001 half dose or VLA2001 full dose) Day 57: VLA2001 selected dose (= either VLA2001 half dose or VLA2001 full dose) Receives: Biological: VLA2001; Drug: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of solicited local and systemic adverse events (AE)
Measured: up to 7 days after each vaccination
Immune response measured after completion of a 2-dose immunization schedule with VLA2001 as determined by the Geometric Mean Titer (GMT)
Measured: 2 weeks after completion of a 2-dose immunization schedule
Immune response measured after completion of a 2-dose immunization schedule with VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific neutralising antibodies
Measured: 2 weeks after completion of a 2-dose immunization schedule
Secondary outcomes (19)
Frequency, causality and severity of any Adverse Event (AE)
Dose Finding Part
Measured: up to Month 12
Frequency and causality of any serious adverse events (SAEs)
Dose Finding Part
Measured: up to Month 12
Frequency, causality and severity of medically-attended AEs (MAAEs)
Dose Finding Part
Measured: up to Month 12
Frequency, causality and severity of adverse events of special interest (AESIs)
Dose Finding Part
Measured: up to Month 12
Immune response of VLA2001 as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific neutralising antibodies
Dose Finding Part
Measured: up to Month 12
Immune response of VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific neutralising antibodies
Dose Finding Part
Measured: up to Month 12
Immune response of VLA2001 as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific S-protein binding antibodies
Dose Finding Part
Measured: up to Month 12
Immune response of VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific S-protein binding antibodies
Dose Finding Part
Measured: up to Month 12
Frequency and severity of solicited local and systemic adverse events (AEs)
Confirmatory Phase
Measured: up to 7 days after each vaccination
Frequency, causality and severity of any unsolicited adverse event (AE) up to 4 weeks following the immunization with VLA2001 (administered as a first dose) in comparison to the vaccination with the comparator vaccine (administered as a first dose)
Confirmatory Phase
Measured: up to 4 weeks following immunization
Frequency, causality and severity of any adverse event (AE)
Confirmatory Phase
Measured: up to Month 12
Frequency, causality and severity of participants with medically-attended adverse events (MAAEs)
Confirmatory Phase
Measured: up to Month 12
Frequency and causality of any serious adverse events (SAEs)
Confirmatory Phase
Measured: up to Month 24
Frequency, causality and severity of adverse events of special interest (AESIs) including multisystem inflammatory syndrome in children (MISC)
Confirmatory Phase
Measured: up to Month 24
Immune response of VLA2001 as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific neutralising antibodies
Confirmatory Phase
Measured: up to Month 12
Immune response of VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific neutralising antibodies
Confirmatory Phase
Measured: up to Month 12
Immune response of VLA2001 as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific S-protein binding antibodies
Confirmatory Phase
Measured: up to Month 12
Immune response of VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific S-protein binding antibodies
Confirmatory Phase
Measured: up to Month 12
Assessment of T-cell responses from PBMCs in participants after in vitro stimulation with SARS-CoV-2 antigens using e.g. ELISpot or intracellular cytokine staining
Measured: up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Oct 2022 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion30 Aug 2025 (estimated)
Why it stopped: Valneva has contacted regulators to align on potential adjustments to the previously agreed Pediatric Investigational Plan. Valneva has suspended VLA2001 pediatric development, and study VLA2001-321 will not commence.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Assignment: 1. st phase: Dose-finding part participants aged ≥5 to \<12 years 2. nd phase: Dose-finding part participants aged ≥2 to \<5 years 3. rd phase: Confirmatory Part participants aged ≥5 to \<12 years 4. th phase: Confirmatory Part participants aged ≥2 to \<5 years
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valneva Austria GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valneva Clinical Deveopment, Study chair, Valneva Austria GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298644
- Sponsor's protocol ID
- VLA2001-321
- Status last verified
- Nov 2022
- First submitted
- 16 Mar 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Active Controlled COVID-19 Study to Evaluate The Safety, Tolerability, And Immunogenicity Of Different Doses Of VLA2001 Vaccine, In Children (≥2 To <12 Years)
- ClinicalTrials.gov ID
- NCT05298644
- Acronym / sponsor ID
- VLA2001-321
- Conditions
- SARS-CoV-2 Infection
- Keywords
- VLA2001, SARS-CoV-2 Infection, COVID-19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Valneva has contacted regulators to align on potential adjustments to the previously agreed Pediatric Investigational Plan. Valneva has suspended VLA2001 pediatric development, and study VLA2001-321 will not commence.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Valneva Austria GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 receive either VLA2001 or active Comparator.
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 parts:
- Dose-finding part (participants aged ≥5 to <12 years)
- Dose-finding part (participants aged ≥2 to <5 years)
- Confirmatory part (participants aged ≥5 to <12 years)
- Confirmatory part (participants aged ≥2 to <5 years)
Dose-finding part (participants aged ≥5 to <12 years) Approximately 60 participants will receive 2 intramuscular doses of either half-dose VLA2001 (n=30) or full-dose VLA2001 (n=30) on Days 1 and 29 in a 1:1 ratio.
Dose-finding part (participants aged ≥2 to <5 years) Approximately 60 participants will receive 2 intramuscular doses of either half-dose VLA2001 (n=30) or full-dose VLA2001 (n=30) on Days 1 and 29 in a 1:1 ratio.
Dose-finding part for age group ≥2 to <5 years will be initiated after dose for age group ≥5 to <12 years is confirmed.
Confirmatory Part (participants aged ≥5 to <12 years and ≥2 to <5 years) Overall, approximately 1600 participants aged ≥2 to <12 years will be enrolled. 800 participants aged ≥5 to <12 years and 800 participants aged ≥2 to <5 years will be randomized in 3:1 ratio. In each age group, 600 participants will receive VLA2001, and 200 participants comparator.
Vaccination will start with either 1 intramuscular dose of VLA2001 (selected dose) or comparator vaccine. 28 days later all participants will receive a dose of VLA2001 (selected dose) and 28 days thereafter those who had received the comparator vaccine will receive their second dose with VLA2001 while those who have already received two doses of VLA2001 will receive the comparator vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Sequential Assignment: 1. st phase: Dose-finding part participants aged ≥5 to <12 years 2. nd phase: Dose-finding part participants aged ≥2 to <5 years 3. rd phase: Confirmatory Part participants aged ≥5 to <12 years 4. th phase: Confirmatory Part participants aged ≥2 to <5 years
| Arm | Type | Receives |
|---|---|---|
| Dose finding ≥5 to <12 years | Experimental | Biological: VLA2001on Day 1 and Day 29 either VLA2001 half dose or VLA2001 full dose |
| Dose finding ≥2 to <5 years | Experimental | Biological: VLA2001on Day 1 and Day 29 either VLA2001 half dose or VLA2001 full dose |
| Confirmatory ≥5 to <12 years | Other | Biological: VLA2001, Drug: Active ComparatorDay 1: VLA2001 selected dose (= either VLA2001 half dose or VLA2001 full dose) Day 29: VLA2001 selected dose (= either VLA2001 half dose or VLA2001 full dose) Day 57: Active Comparator |
| Confirmatory ≥2 to <5 years | Other | Biological: VLA2001, Drug: Active ComparatorDay 1: Active Comparator Day 29: VLA2001 selected dose (= either VLA2001 half dose or VLA2001 full dose) Day 57: VLA2001 selected dose (= either VLA2001 half dose or VLA2001 full dose) |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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.
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VLA2001whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG)1018 in combination with aluminium hydroxide | Biological | Confirmatory ≥2 to <5 years, Confirmatory ≥5 to <12 years, Dose finding ≥2 to <5 years, Dose finding ≥5 to <12 years |
| Active ComparatorMenactra, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine. | Drug | Confirmatory ≥2 to <5 years, Confirmatory ≥5 to <12 years |
Primary outcome
Frequency and severity of solicited local and systemic adverse events (AE)
Time frame: up to 7 days after each vaccination
Immune response measured after completion of a 2-dose immunization schedule with VLA2001 as determined by the Geometric Mean Titer (GMT)
Time frame: 2 weeks after completion of a 2-dose immunization schedule
Immune response measured after completion of a 2-dose immunization schedule with VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific neutralising antibodies
Time frame: 2 weeks after completion of a 2-dose immunization schedule
19 secondary outcomes
Frequency, causality and severity of any Adverse Event (AE)
Time frame: up to Month 12
Frequency and causality of any serious adverse events (SAEs)
Time frame: up to Month 12
Frequency, causality and severity of medically-attended AEs (MAAEs)
Time frame: up to Month 12
Frequency, causality and severity of adverse events of special interest (AESIs)
Time frame: up to Month 12
Immune response of VLA2001 as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific neutralising antibodies
Time frame: up to Month 12
Immune response of VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific neutralising antibodies
Time frame: up to Month 12
Immune response of VLA2001 as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific S-protein binding antibodies
Time frame: up to Month 12
Immune response of VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific S-protein binding antibodies
Time frame: up to Month 12
Frequency and severity of solicited local and systemic adverse events (AEs)
Time frame: up to 7 days after each vaccination
Frequency, causality and severity of any unsolicited adverse event (AE) up to 4 weeks following the immunization with VLA2001 (administered as a first dose) in comparison to the vaccination with the comparator vaccine (administered as a first dose)
Time frame: up to 4 weeks following immunization
Frequency, causality and severity of any adverse event (AE)
Time frame: up to Month 12
Frequency, causality and severity of participants with medically-attended adverse events (MAAEs)
Time frame: up to Month 12
Frequency and causality of any serious adverse events (SAEs)
Time frame: up to Month 24
Frequency, causality and severity of adverse events of special interest (AESIs) including multisystem inflammatory syndrome in children (MISC)
Time frame: up to Month 24
Immune response of VLA2001 as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific neutralising antibodies
Time frame: up to Month 12
Immune response of VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific neutralising antibodies
Time frame: up to Month 12
Immune response of VLA2001 as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific S-protein binding antibodies
Time frame: up to Month 12
Immune response of VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific S-protein binding antibodies
Time frame: up to Month 12
Assessment of T-cell responses from PBMCs in participants after in vitro stimulation with SARS-CoV-2 antigens using e.g. ELISpot or intracellular cytokine staining
Time frame: up to Month 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valneva Clinical Deveopment study chair
Valneva Austria GmbH
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing VLA2001 and Active Comparator in people with SARS-CoV-2 Infection, run by Valneva Austria GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of solicited local and systemic adverse events (AE) (time frame: up to 7 days after each vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.