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
|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|
|Estimated Enrollment :||6750 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 10, 2023|
|Estimated Study Completion Date :||June 10, 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 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 second dose) ]
- Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 57 (1 month after second dose) ]
- Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Up to Day 394 (1 year after second dose) ]
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Day 394 (1 year after second dose) ]
- 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) ]
- 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.
- Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb) [ Time Frame: Day 57 (1 month after second dose) ]
- Seroresponse Rate of Vaccine Recipients [ Time Frame: Day 57 (1 month after second dose) ]
- 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 nAb [ Time Frame: Day 1, Day 57, Day 209, and Day 394 ]
- 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.
- Number of Participants with Asymptomatic SARS-CoV-2 Infections [ Time Frame: Up to Day 394 ]
- 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.
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 Trialsemail@example.com|