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History of Changes for Study: NCT04796896
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
Latest version (submitted April 25, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 11, 2021 None (earliest Version on record)
2 March 17, 2021 Recruitment Status, Study Status, References, Contacts/Locations, Study Design and Study Description
3 March 26, 2021 Contacts/Locations and Study Status
4 April 5, 2021 Study Status and Contacts/Locations
5 April 12, 2021 Contacts/Locations and Study Status
6 April 25, 2021 Contacts/Locations and Study Status
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Study NCT04796896
Submitted Date:  March 17, 2021 (v2)

Open or close this module Study Identification
Unique Protocol ID: mRNA-1273-P204
Brief Title: 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
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2021
Overall Status: Recruiting
Study Start: March 15, 2021
Primary Completion: June 10, 2023 [Anticipated]
Study Completion: June 10, 2023 [Anticipated]
First Submitted: March 11, 2021
First Submitted that
Met QC Criteria:
March 11, 2021
First Posted: March 15, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 17, 2021
Last Update Posted: March 19, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: ModernaTX, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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.
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.

Open or close this module Conditions
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID-19
COVID-19 Vaccine
Moderna
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2/Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 6750 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Up to Day 36 (7 days after second dose)
2. Number of Participants with Unsolicited Adverse Events (AEs)
Up to Day 57 (1 month after second dose)
3. Number of Participants with Medically-Attended AEs (MAAEs)
Up to Day 394 (1 year after second dose)
4. Number of Participants with Serious Adverse Events (SAEs)
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)
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
Threshold of protection as predefined for study.

[Time Frame: Day 57 (1 month after second dose)]
7. Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Day 57 (1 month after second dose)
8. Seroresponse Rate of Vaccine Recipients
Day 57 (1 month after second dose)
Secondary Outcome Measures:
9. GM of SARS-CoV-2 S-Protein Specific Binding Antibody (bAb)
Day 1, Day 57, Day 209, and Day 394
10. GM of SARS-CoV-2 Specific nAb
Day 1, Day 57, Day 209, and Day 394
11. Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology Starting 14 Days After the Second Dose
Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.

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

[Time Frame: Day 43 to Day 394]
Open or close this module Eligibility
Minimum Age: 6 Months
Maximum Age: 11 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Moderna Clinical Trials
Telephone: 877-913-3286
Email: clinicaltrials@modernatx.com
Locations: United States, Kentucky
Michael W Simon, MD PSC
[Recruiting]
Lexington, Kentucky, United States, 40517-8379
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Click here to access the website, http://www.kidcovestudy.com, for additional information for the study, such as Study Overview, Participation, Site Locations, along with contact numbers for each location for the study.
Available IPD/Information:

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