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

• ClinicalTrials.gov Identifier: NCT05584202
• Recruitment Status: Recruiting
• First Posted: October 18, 2022
• Last Update Posted: March 15, 2024
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Tracking Information

• First Submitted Date: October 14, 2022
• First Posted Date: October 18, 2022
• Last Update Posted Date: March 15, 2024
• Actual Study Start Date: September 30, 2022
• Estimated Primary Completion Date: March 8, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 14, 2022)

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 64 (7 days after each vaccination) ]
• Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 85 (28 days after each vaccination) ]
• Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs) [ Time Frame: Up to Day 422 ]
• Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibodies Against Omicron Variant [ Time Frame: Day 85 (28 days after the second vaccination) ]
• Seroresponse Rate Against SARS-CoV-2 Omicron Variant [ Time Frame: Day 85 (28 days after the second vaccination) ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 14, 2022)

• GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 1) [ Time Frame: Day 85 (28 days after the second vaccination) ]
• GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 2) [ Time Frame: Day 85 (28 days after the second vaccination) ]
• Seroresponse Rate Against SARS-CoV-2 Omicron Variant (Part 2) [ Time Frame: Day 85 (28 days after the second vaccination) ]
• GMT of SARS-CoV-2 Antibodies Against Original Strain (Part 2) [ Time Frame: Day 85 (28 days after the second vaccination) ]
• Seroresponse Rate Against SARS-CoV-2 Original Strain (Part 2) [ Time Frame: Day 85 (28 days after the second vaccination) ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273.214 SARS-CoV-2 (COVID-19) Vaccine in Infants
• 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
• Brief 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.
• Detailed 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 Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Part 1: sequential Part 2: parallel

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Part 1: open-label Part 2: observer-blinded, randomized, placebo-controlled

Primary Purpose: Prevention

• Condition: SARS-CoV-2

Intervention

• Biological: mRNA-1273.214
  Sterile liquid for injection
• Other: Placebo
  0.9% sodium chloride
  Other Name: normal saline

Study Arms

• Experimental: Part 1: mRNA-1273.214 Dose A
  Participants will receive 2 doses of mRNA-1273.214 Dose A by intramuscular (IM) injection approximately 8 weeks apart (Day 1 and Day 57).
  Intervention: Biological: mRNA-1273.214
• Experimental: Part 1: mRNA-1273.214 Dose B
  Participants will receive 2 doses of mRNA-1273.214 Dose B by IM injection approximately 8 weeks apart (Day 1 and Day 57).
  Intervention: Biological: mRNA-1273.214
• Experimental: Part 2: mRNA-1273.214
  Participants will receive 2 doses of mRNA-1273.214 by IM injection approximately 8 weeks apart (Day 1 and Day 57).
  Intervention: Biological: mRNA-1273.214
• Placebo Comparator: Part 2: Placebo
  Participants will receive 2 doses of placebo by IM injection approximately 8 weeks apart (Day 1 and Day 57).
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 14, 2022): 700
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 8, 2025
• Estimated Primary Completion Date: March 8, 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

Key Inclusion Criteria:

• Participant is male or female, between 2 and <6 months of age at the time of consent (Screening Visit), who is in good general health, in the opinion of the investigator, based on review of medical history and screening physical examination.

  1. Participant must be at least 12 weeks completed age and must not have completed 6 months at the time of administration of first dose.
  2. If the participant has a chronic, stable disease, they may be eligible to enroll in Part 2, but ineligible for Part 1. The chronic condition (for example, gastroesophageal reflux disease) should be stable, per investigator assessment, so that the participant can be considered eligible for inclusion in Part 2.
• Participant was born at ≥37 weeks gestation (Part 1) or ≥34 weeks gestation (Part 2), with a minimum birth weight of 2.5 kilograms (kg), without fetal growth restriction, and the participant's height and weight are both at or above the second percentile for age according to the Centers for Disease Control and Prevention/World Health Organization Child Growth Standard at the Screening Visit.
• In the investigator's opinion, the parent(s)/legally authorized representative(s) understand and are willing and physically able to comply with protocol-mandated follow-up, including all procedures, and provide written informed consent.

Key Exclusion Criteria:

• Participant has a known history of SARS-CoV-2 infection within 2 weeks prior to administration of study drug or has a known close contact in the past 2 weeks to someone diagnosed with SARS-CoV-2 infection or coronavirus disease 2019 (COVID-19). Participants may be rescreened after 14 days provided that they remain asymptomatic.
• Participant is acutely ill or febrile 72 hours prior to or at the Screening Visit. Fever is defined as a body temperature ≥38.0°Celcius/≥100.4°Farenheit. Participants who meet this criterion may have visits rescheduled within the relevant study visit windows. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
• Participant has previously been administered an investigational or approved CoV (for example, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome [MERS]-CoV) vaccine.
• Participant has undergone treatment with investigational or approved agents for prophylaxis against COVID-19 (for example, receipt of SARS-CoV-2 monoclonal antibodies) within 90 days prior to enrollment.
• Participant has a known hypersensitivity to a component of the vaccine or its excipients. Hypersensitivity includes, but is not limited to, anaphylaxis or immediate allergic reaction of any severity to any of the components of messenger ribonucleic acid (mRNA) COVID-19 vaccines (including polyethylene glycol or immediate allergic reaction of any severity to polysorbate).
• Participant has a medical, psychiatric, or occupational 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.
• Participant has a history of diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety.

• Participant has received the following:

  1. Any routine vaccination with inactivated or live vaccine(s) within 14 days prior to first or second vaccination or plans to receive such a vaccine within 14 days of any study vaccination.
  2. Systemic immunosuppressants or immune-modifying drugs (including maternal use during pregnancy or lactation) for >14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥ 1 milligrams (mg)/kg/day or, if participant weighs >10 kg: ≥10 mg/day prednisone equivalent). Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids are allowed.
  3. Intravenous or subcutaneous blood products (red blood cells, platelets, immunoglobulins) within 3 months prior to enrollment.
• Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit or plans to do so while participating in this study, or maternal participation in an interventional clinical study during pregnancy.

Note: Other inclusion and exclusion criteria may apply.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Months to 6 Months (Child)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Moderna Clinical Trials Support Center; 1-877-777-7187; clinicaltrials@modernatx.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05584202
• Other Study ID Numbers: mRNA-1273-P206
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: ModernaTX, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ModernaTX, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ModernaTX, Inc.
• Verification Date: March 2024