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)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Immune response measured after completion of a 2-dose immunization schedule with VLA2001 as determined by the Geometric Mean Titer (GMT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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).
- •Any member of the study team or sponsor.
- •An immediate family member or household member of the study's personnel.
研究组 & 干预措施
Dose finding ≥5 to <12 years
on Day 1 and Day 29 either VLA2001 half dose or VLA2001 full dose
干预措施: VLA2001 (Biological)
Dose finding ≥2 to <5 years
on Day 1 and Day 29 either VLA2001 half dose or VLA2001 full dose
干预措施: VLA2001 (Biological)
Confirmatory ≥5 to <12 years
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
干预措施: VLA2001 (Biological)
Confirmatory ≥5 to <12 years
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
干预措施: Active Comparator (Drug)
Confirmatory ≥2 to <5 years
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)
干预措施: VLA2001 (Biological)
Confirmatory ≥2 to <5 years
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)
干预措施: Active Comparator (Drug)
结局指标
主要结局
Immune response measured after completion of a 2-dose immunization schedule with VLA2001 as determined by the Geometric Mean Titer (GMT)
时间窗: 2 weeks after completion of a 2-dose immunization schedule
Frequency and severity of solicited local and systemic adverse events (AE)
时间窗: up to 7 days after each vaccination
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
时间窗: 2 weeks after completion of a 2-dose immunization schedule
次要结局
- 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(up to Month 12)
- Frequency and severity of solicited local and systemic adverse events (AEs)(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)(up to 4 weeks following immunization)
- Frequency, causality and severity of any adverse event (AE)(up to Month 12)
- 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 24)
- 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)
- Immune response of VLA2001 as determined by seroconversion rate (SCR) (defined as 4-fold increase from baseline) of SARS-CoV-2-specific neutralising antibodies(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(up to Month 12)
- Frequency, causality and severity of participants with medically-attended adverse events (MAAEs)(up to Month 12)
- Frequency, causality and severity of adverse events of special interest (AESIs) including multisystem inflammatory syndrome in children (MISC)(up to Month 24)
- 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(up to Month 12)