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A Study to Evaluate Safety and Effectiveness of mRNA-1273 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age

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ClinicalTrials.gov Identifier: NCT04796896
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Biological: mRNA-1273 Biological: Placebo Phase 2 Phase 3

Detailed 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.

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Study Type : Interventional
Estimated Enrollment : 6750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Part 1 is Open-label; Part 2 Randomized and Observer-blind
Primary Purpose: Prevention
Official Title: A Phase 2/3, Two-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : June 10, 2023
Estimated Study Completion Date : June 10, 2023

Arm Intervention/treatment
Experimental: mRNA-1273

Part 1: Participants will receive 2 intramuscular (IM) injections of mRNA-1273 at up to 3 doses pre-specified for this study, 28 days apart, on Day 1 and Day 29.

Part 2: Participants will receive 2 IM injections of of mRNA-1273 at the dose selected from Part 1, 28 days apart, on Day 1 and Day 29.

Biological: mRNA-1273
Sterile liquid for injection

Placebo Comparator: Placebo
Part 2 only: Participants will receive 2 IM injections of mRNA-1273-matching placebo 28 days apart, on Day 1 and Day 29.
Biological: Placebo
0.9% sodium chloride (normal saline) injection




Primary Outcome Measures :
  1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 36 (7 days after second dose) ]
  2. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (1 month after second dose) ]
  3. Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Up to Day 394 (1 year after second dose) ]
  4. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 394 (1 year after second dose) ]
  5. Number of Participants with Adverse Events of Special Interest (AESIs), including Multisystem Inflammatory Syndrome in Children (MIS-C) [ Time Frame: Up to Day 394 (1 year after second dose) ]
  6. Number of Participants with Serum Antibody (Ab) Levels that Meet or Exceed the Threshold of Protection from COVID-19 [ Time Frame: Day 57 (1 month after second dose) ]
    Threshold of protection as predefined for study.

  7. Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) [ Time Frame: Day 57 (1 month after second dose) ]
  8. Seroresponse Rate of Vaccine Recipients [ Time Frame: Day 57 (1 month after second dose) ]

Secondary Outcome Measures :
  1. GM of SARS-CoV-2 S-Protein Specific Binding Antibody (bAb) [ Time Frame: Day 1, Day 57, Day 209, and Day 394 ]
  2. GM of SARS-CoV-2 Specific nAb [ Time Frame: Day 1, Day 57, Day 209, and Day 394 ]
  3. Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology Starting 14 Days After the Second Dose [ Time Frame: Day 43 to Day 394 ]
    Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.

  4. Number of Participants with Asymptomatic SARS-CoV-2 Infections [ Time Frame: Up to Day 394 ]
  5. Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose [ Time Frame: Day 43 to Day 394 ]
    Clinical signs indicative of COVID-19 as predefined for the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key 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.
  • 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 <2 years of age: born at full-term with a minimum birth weight of 2.5 kilograms (kg).

Key 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04796896


Contacts
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Contact: Moderna Clinical Trials 877-913-3286 clinicaltrials@modernatx.com

Locations
Show Show 19 study locations
Sponsors and Collaborators
ModernaTX, Inc.
Additional Information:
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04796896    
Other Study ID Numbers: mRNA-1273-P204
First Posted: March 15, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna