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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04796896|
Recruitment Status : Recruiting
First Posted : March 15, 2021
Last Update Posted : October 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV-2||Biological: mRNA-1273 Biological: Placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||13275 participants|
|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|
|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 12, 2023|
|Estimated Study Completion Date :||June 12, 2023|
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 mRNA-1273 at the dose selected from Part 1, 28 days apart, on Day 1 and Day 29.
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.
0.9% sodium chloride (normal saline) injection
- Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 36 (7 days after each injection) ]
- Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (28 days after each injection) ]
- Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Up to Day 394 (1 year after second injection) ]
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 394 (1 year after second injection) ]
- Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C), Myocarditis and/or Pericarditis [ Time Frame: Up to Day 394 (1 year after second injection) ]
- Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19 [ Time Frame: Day 57 (1 month after second injection) ]Threshold of protection as predefined for study.
- Geometric Mean (GM) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody [ Time Frame: Day 57 (1 month after second injection) ]
- Seroresponse Rate of Vaccine Recipients [ Time Frame: Day 57 (1 month after second injection) ]
- GM of SARS-CoV-2 S-Protein-Specific Binding Antibody (bAb) [ Time Frame: Day 1, Day 57, Day 209, and Day 394 ]
- GM of SARS-CoV-2- Specific Neutralizing Antibody (nAb) [ Time Frame: Day 1, Day 57, Day 209, and Day 394 ]
- Number of Participants with SARS-CoV-2 Infections Regardless of Symptomatology, as Assessed by Serology and/or Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) [ Time Frame: Up to Day 394 ]Clinical signs indicative of SARS-CoV-2 infection as predefined for the study.
- Number of Participants with SARS-CoV-2 Infection Measured by RT-PCR and/or bAb Levels Against SARS-CoV-2 Nucleocapsid Protein in Participants with Negative SARS-CoV-2 at Baseline, in the Absence of Any COVID-19 Symptoms [ Time Frame: Up to Day 394 ]
- Number of Participants with a First Occurrence of COVID-19 [ Time Frame: Up to Day 394 ]Clinical signs indicative of COVID-19 as predefined for the study.
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
|Contact: Moderna Clinical Trialsfirstname.lastname@example.org|