Clinical Trials Logo
  1. Home
  2. SARS-CoV-2
  3. NCT05584202

Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants — BabyCOVE  

SARS-CoV-2 Clinical Trial

Official title:
A Phase 2, Two-Part Study (Open-Label [Part 1] Followed by Observer-Blind/Randomized [Part 2]) to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 Vaccine in Participants Aged 12 Weeks to < 6 Months

Clinical Trial Summary

The study will evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273.214 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in infants aged 12 weeks to < 6 months.

Clinical Trial Description

The study will be conducted in 2 parts. Part 1 will be open-label and evaluate 2 dose levels. The dose level selected from Part 1 will be further evaluated in Part 2, which will be blinded and randomized. This pediatric study is intended to confirm safety and effectiveness of mRNA-1273.214 in infants between 12 weeks to < 6 months of age by comparing the immune response of infants in this study to adults (>18 years of age) enrolled in the mRNA-1273-P301 study [NCT04470427]). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05584202
Study type Interventional
Source ModernaTX, Inc.
Contact Moderna Clinical Trials Support Center
Phone 1-877-777-7187
Email clinicaltrials@modernatx.com
Status Recruiting
Phase Phase 2
Start date September 30, 2022
Completion date March 8, 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04527471 - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Completed NCT04579549 - Repeat Testing for SARS-CoV-2 N/A
Active, not recruiting NCT05547243 - A Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants in China N/A
Recruiting NCT04747574 - Evaluation of the Safety of CD24-Exosomes in Patients With COVID-19 Infection Phase 1
Recruiting NCT04613310 - PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19) N/A
Terminated NCT04447404 - DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury Phase 2
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Withdrawn NCT04388709 - Interferon Lambda Therapy for COVID-19 Phase 2
Active, not recruiting NCT05550142 - A Preliminary Exploratory Cohort Study of SARS-CoV-2 Variant (Omicron BA.5) mRNA Vaccine in Participants Aged 18 Years and Over in China N/A
Completed NCT04620798 - Longitudinal COVID-19 Antibody Testing in Indiana University Undergraduate Students N/A
Active, not recruiting NCT05547256 - A Preliminary Exploratory Cohort Study of COVID-19 mRNA Vaccine, Bivalent in Participants Aged 18 Years and Over in China N/A
Completed NCT04561102 - Evaluation of the COVIDSeq Test in Nasal Swab and Saliva From a COVID-19 Asymptomatic Population
Completed NCT04452604 - Multicentric Registry of Patients With Acute Leukemia Infected by COVID-19
Completed NCT05366322 - A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
Terminated NCT04958304 - Moderna COVID-19 Vaccine mRNA-1273 Observational Pregnancy Outcome Study
Completed NCT04526769 - Detecting SARS-CoV-2 in Tears
Completed NCT04690413 - NOWDx Test for the Detection of Antibodies to COVID-19 N/A
Active, not recruiting NCT05939648 - A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) Phase 2