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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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22 April 2024 |
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Main ID: |
EUCTR2023-000482-14-Outside-EU/EEA |
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Date of registration:
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19/04/2024 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants
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Scientific title:
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A Phase 2, Two-Part Study (Open-Label [Part 1] Followed by Observer-Blind/Randomized [Part 2]) to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 Vaccine in Participants Aged 12 Weeks to < 6 Months - BabyCOVE |
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Date of first enrolment:
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Target sample size:
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Recruitment status: |
NA |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2023-000482-14 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Part 1 (sequential) is open label; Part 2 (parallel) is observer blind/randomized. If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 4
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Brazil
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Colombia
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Guatemala
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Kenya
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Mexico
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Panama
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Singapore
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South Africa
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United States
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Contacts
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Name:
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Moderna Clinical Trials
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Address:
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325 Binney Street
02142
Cambridge, MA
United States |
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Telephone:
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1877777-7187 |
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Email:
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clinicaltrials@modernatx.com |
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Affiliation:
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ModernaTX, Inc. |
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Name:
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Moderna Clinical Trials
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Address:
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325 Binney Street
02142
Cambridge, MA
United States |
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Telephone:
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1877777-7187 |
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Email:
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clinicaltrials@modernatx.com |
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Affiliation:
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ModernaTX, Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria:
• Participant is male or female, between 2 and <6 months of age at the time of consent (Screening Visit), who is in good general health, in the opinion of the investigator, based on review of medical history and screening physical examination.
a. Participant must be at least 12 weeks completed age and must not have completed 6 months at the time of administration of first dose.
b. If the participant has a chronic, stable disease, they may be eligible to enroll in Part 2, but ineligible for Part 1. The chronic condition (for example, gastroesophageal reflux disease) should be stable, per investigator assessment, so that the participant can be considered eligible for inclusion in Part 2.
• Participant was born at =37 weeks gestation (Part 1) or =34 weeks gestation (Part 2), with a minimum birth weight of 2.5 kilograms (kg), without fetal growth restriction, and the participant’s height and weight are both at or above the second percentile for age according to the Centers for Disease Control and Prevention/World Health Organization Child Growth Standard at the Screening Visit.
Are the trial subjects under 18? yes
Number of subjects for this age range: 700
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
• Participant has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of study drug or has a known close contact in the past 2 weeks to someone diagnosed with SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19). Participants may be rescreened after 14 days provided that they remain asymptomatic.
• Participant is acutely ill or febrile 72 hours prior to or at the Screening Visit. Fever is defined as a body temperature =38.0°Celcius/=100.4°Farenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
• Participant has previously been administered an investigational or approved CoV (for example, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome-CoV) vaccine.
• Participant has undergone treatment with investigational or approved agents for prophylaxis against COVID-19 (for example, receipt of SARS-CoV-2 monoclonal antibodies) within 90 days prior to enrollment.
• Participant has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to any of the components of messenger ribonucleic acid COVID-19 vaccines (including polyethylene glycol or immediate allergic reaction of any severity to polysorbate).
• Participant has a medical, psychiatric, or occupational condition, that, according to the investigator’s judgment, may pose additional risk as a result of participation, interfere with safety assessments, or interfere with interpretation of results.
• Participant has a history of diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.
• Participant has received the following:
a. Any routine vaccination with inactivated or live vaccine(s) within 14 days prior to first or second vaccination or plans to receive such a vaccine within 14 days of any study vaccination.
b. Systemic immunosuppressants or immune-modifying drugs (including maternal use during pregnancy or lactation) for >14 days in total within 6 months prior to the day of enrollment (for corticosteroids, = 1 mg/kg/day or, if participant weighs >10 kg: =10 mg/day prednisone equivalent). Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids are allowed.
c. Intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to enrollment.
• Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit or plans to do so while participating in this study, or maternal participation in an interventional clinical study during pregnancy.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Coronavirus Disease 2019
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Therapeutic area: Diseases [C] - Virus Diseases [C02]
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Intervention(s)
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Product Name: mRNA-1273.214
Product Code: mRNA-1273.214
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intramuscular use
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Primary Outcome(s)
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Main Objective: The study will evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 SARS-CoV-2 vaccine in infants aged 12 weeks to < 6 months.
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Secondary Objective: • To evaluate the immunogenicity of 2 dose levels1 of mRNA-1273.214 vaccine administered as 2 doses 8 weeks apart in participants aged 12 weeks to < 6 months
• To evaluate the immune response against SARS-CoV-2 variants of concern (Omicron) elicited by mRNA-1273.214 vaccine administered as 2 doses 8 weeks apart in participants aged 12 weeks to < 6 months, compared with the immune responses against original strain induced by mRNA-1273 primary series (2 doses 28 days apart)
• To evaluate the immune response against SARS-CoV-2 original strain elicited by mRNA-1273.214 vaccine administered as 2 doses 8 weeks apart in participants aged 12 weeks to < 6 months, compared with the immune responses against original strain induced by mRNA-1273 primary series (2 doses 28 days apart)
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Timepoint(s) of evaluation of this end point: • Up to Day 64 (7 days after each vaccination)
• Up to Day 85 (28 days after each vaccination)
• Up to Day 422
• Day 85 (28 days after the second vaccination)
• Day 85 (28 days after the second vaccination)
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Primary end point(s): • Number of Participants with Solicited Local and Systemic Adverse Reactions
• Number of Participants with Unsolicited Adverse Events (AEs)
• Number of Participants with Serious AEs, Medically Attended AEs, AEs Leading to Withdrawal, and AEs of Special Interest
• Geometric Mean Titer (GMT) of SARS-CoV-2 Antibodies Against Omicron Variant
• Seroresponse Rate Against SARS-CoV-2 Omicron Variant
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Secondary Outcome(s)
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Secondary end point(s): • GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 1)
• GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 2)
• Seroresponse Rate Against SARS-CoV-2 Omicron Variant (Part 2)
• GMT of SARS-CoV-2 Antibodies Against Original Strain (Part 2)
• Seroresponse Rate Against SARS-CoV-2 Original Strain (Part 2)
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Timepoint(s) of evaluation of this end point: • Day 85 (28 days after the second vaccination)
• Day 85 (28 days after the second vaccination)
• Day 85 (28 days after the second vaccination)
• Day 85 (28 days after the second vaccination)
• Day 85 (28 days after the second vaccination)
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Secondary ID(s)
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mRNA-1273-P206
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NCT05584202
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Source(s) of Monetary Support
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ModernaTX, Inc.
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Ethics review
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Status:
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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