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

  • STATUS
    Recruiting
  • End date
    Jun 12, 2023
  • participants needed
    13275
  • sponsor
    ModernaTX, Inc.
Updated on 24 September 2021

Summary

The primary goal for this study is to evaluate up to 3 dose levels of mRNA-1273 vaccine given to healthy children in 2 doses, 28 days apart.

Description

This is a Phase 2/3, 2-part, open-label, dose-escalation, age de-escalation, randomized, observer-blind, placebo-controlled, expansion study intended to infer the effectiveness of mRNA-1273 in children aged 6 months to less than 12 years.

Please access http://www.kidcovestudy.com for additional information, such as Study Overview, Participation, Site Locations along with contact numbers for each location for the study.

Details
Condition Sars Cov 2
Treatment Placebo, mRNA-1273
Clinical Study IdentifierNCT04796896
SponsorModernaTX, Inc.
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

For participants with chronic diseases (such as, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [HIV] infection), the disease should be stable, per investigator assessment
Investigator assessment that the parent(s)/legally acceptable representatives understand and are willing and physically able to comply with protocol mandated follow up, including all procedures, written informed consent is provided, and participants provide assent
For children 2 years of age or older has a body mass index at or above the third percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit
For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, agreement to continue adequate contraception or abstinence through 3 months following the second injection, and not currently breastfeeding
For children 6 months to <12 months of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg)

Exclusion Criteria

Known history of SARS-CoV-2 infection within 2 weeks prior to administration of vaccine or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to administration of vaccine
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
A medical or psychiatric 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
History of a diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety
Received any non-study vaccine within 14 days before or after any dose of vaccine (except for seasonal influenza vaccine, which is not permitted within 14 days before or after any dose of vaccine)
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 or plans to donate blood products while participating in this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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