A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age
- Conditions
- Coronavirus Disease 2019Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2021-000281-15-Outside-EU/EEA
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- Not specified
• Healthy children and those with stable chronic disease.
• For children 2 years of age or older has a body mass index at or above the third percentile according to World Health Organization Child Growth Standards at the Screening Visit.
• For children 6 months to <12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms.
Are the trial subjects under 18? yes
Number of subjects for this age range: 11950
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
• Known history of SARS-CoV-2 infection within 2 weeks prior to administration of vaccine or known close contact.
• Prior administration of an investigational or approved CoV (such as, SARS-CoV-2, SARS CoV, Middle East Respiratory Syndrome CoV) vaccine.
• Treatment with investigational or approved agents for prophylaxis against COVID 19 (such as, receipt of SARS-CoV-2 monoclonal antibodies) within 6 months prior to enrollment.
• Known hypersensitivity to a component of the vaccine or its excipients.
• Received intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to Day 1.
• Participated in an interventional clinical study within 28 days prior to Day 0.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method