COVID-19 Paediatric VLA2001-321 Study

NCT05298644 | Withdrawn Phase 2 DMC

• 1 other identifier: VLA2001-321
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 receive either VLA2001 or active Comparator.

Conditions

SARS-CoV-2 Infection

Keywords

VLA2001; SARS-CoV-2 Infection; COVID-19

Outcome Measures

Primary Outcomes (3)

• Frequency and severity of solicited local and systemic adverse events (AE)

  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)

  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

  2 weeks after completion of a 2-dose immunization schedule

Secondary Outcomes (19)

• Frequency, causality and severity of any Adverse Event (AE)

  up to Month 12

• Frequency and causality of any serious adverse events (SAEs)

  up to Month 12

• Frequency, causality and severity of medically-attended AEs (MAAEs)

  up to Month 12

• Frequency, causality and severity of adverse events of special interest (AESIs)

  up to Month 12

• Immune response of VLA2001 as determined by the Geometric Mean Titer (GMT) of SARS-CoV-2-specific neutralising antibodies

  up to Month 12

Study Arms (4)

Dose finding ≥5 to <12 years

EXPERIMENTAL

on Day 1 and Day 29 either VLA2001 half dose or VLA2001 full dose

Biological: VLA2001

Dose finding ≥2 to <5 years

EXPERIMENTAL

on Day 1 and Day 29 either VLA2001 half dose or VLA2001 full dose

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

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)

Biological: VLA2001; Drug: Active Comparator

Interventions

VLA2001 BIOLOGICAL

whole virus inactivated SARS-CoV-2 vaccine adjuvanted with cytosine phospho-guanine (CpG)1018 in combination with aluminium hydroxide

Confirmatory ≥2 to <5 years; Confirmatory ≥5 to <12 years; Dose finding ≥2 to <5 years; Dose finding ≥5 to <12 years

Active Comparator DRUG

Menactra, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine.

Confirmatory ≥2 to <5 years; Confirmatory ≥5 to <12 years

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Valneva Austria GmbH: lead

MeSH Terms

Conditions

COVID-19

Interventions

VLA2001 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Valneva Clinical Deveopment

  Valneva Austria GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 28, 2022
• Study Start: October 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: August 30, 2025
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share