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

SARS-CoV-2 Clinical Trial

— BabyCOVE  

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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05584202
• Other study ID #: mRNA-1273-P206
• Status: Recruiting
• Phase: Phase 2
• Start date: September 30, 2022
• Est. completion date: March 8, 2025

Study information

• Verified date: March 2024
• Source: ModernaTX, Inc.
• Contact: Moderna Clinical Trials Support Center
• Phone: 1-877-777-7187
• Email: clinicaltrials[@]modernatx.com
• Is FDA regulated: No
• Study type: Interventional

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.

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]).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: March 8, 2025
• Est. primary completion date: March 8, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Biological:
• mRNA-1273.214
Sterile liquid for injection

Other:
• Placebo
0.9% sodium chloride

Locations

Country	Name	City	State
United States	Medical Research Partners- Ammon	Ammon	Idaho
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	Trinity Clinical Research, LLC - Bessemer	Bessemer	Alabama
United States	UAB Pediatrics	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	PI-Coor Clinical Research LLC	Burke	Virginia
United States	Coastal Pediatric Research	Charleston	South Carolina
United States	PAS Research	Clearwater	Florida
United States	South Texas Clinical Research - Corpus Christi	Corpus Christi	Texas
United States	MedPharmics - Platinum - PPDS	Covington	Louisiana
United States	Cedar Health Research - Dedicated Research Facility	Dallas	Texas
United States	Prohealth Research Center	Doral	Florida
United States	Duke Vaccine and Trials Units	Durham	North Carolina
United States	Child Health Care Associates	East Syracuse	New York
United States	DM Clinical Research - Kool Kids Pediatrics - ERN - PPDS	Houston	Texas
United States	University of Florida Jackonsville	Jacksonville	Florida
United States	Kissimmee Clinical Research	Kissimmee	Florida
United States	UCSD Altman Clinical and Translational Research	La Jolla	California
United States	MedPharmics - Platinum - PPDS	Lafayette	Louisiana
United States	Tanner Clinic	Layton	Utah
United States	Wee Care Pediatrics - Layton Office	Layton	Utah
United States	Michael W Simon MD, PSC	Lexington	Kentucky
United States	Be Well Clinical Studies	Lincoln	Nebraska
United States	Arkansas Children's Research Hospital	Little Rock	Arkansas
United States	Madera Family Medical Group	Madera	California
United States	Le Bonheur Childrens Hospital	Memphis	Tennessee
United States	Acevedo Clinical Research	Miami	Florida
United States	D&H National Research Centers	Miami	Florida
United States	Dedicated Research Facility	Miami	Florida
United States	L&A Morales Healthcare, Inc	Miami	Florida
United States	Suncoast Research Associates LLC - ERN - PPDS	Miami	Florida
United States	Excellence Medical and Research LLC	Miami Gardens	Florida
United States	Clinical Research Institute, Inc	Minneapolis	Minnesota
United States	SeraCollection Research Services LLC	Montebello	California
United States	Center For Clinical Trials LLC	Paramount	California
United States	Advances In Health Inc	Pearland	Texas
United States	The Children's Hospital of Philadephia	Philadelphia	Pennsylvania
United States	UPMC University Center	Pittsburgh	Pennsylvania
United States	Victoria Clinical Research Group	Port Lavaca	Texas
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Wee Care Pediatrics	Roy	Utah
United States	KM International Research Operation - Saint Cloud	Saint Cloud	Florida
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	Stony Brook University Medical Center	Stony Brook	New York
United States	Wee Care Pediatrics	Syracuse	Utah
United States	PAS Research	Tampa	Florida
United States	Eclipse Clinical Research	Tucson	Arizona
United States	Meridian Clinical Research (Washington) - PPDS	Washington	District of Columbia
United States	Velocity Clinical Research (Hastings - Nebraska) - PPDS	Wilmington	North Carolina
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 64 (7 days after each vaccination)
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 85 (28 days after each vaccination)
Primary	Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs)		Up to Day 422
Primary	Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibodies Against Omicron Variant		Day 85 (28 days after the second vaccination)
Primary	Seroresponse Rate Against SARS-CoV-2 Omicron Variant		Day 85 (28 days after the second vaccination)
Secondary	GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 1)		Day 85 (28 days after the second vaccination)
Secondary	GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 2)		Day 85 (28 days after the second vaccination)
Secondary	Seroresponse Rate Against SARS-CoV-2 Omicron Variant (Part 2)		Day 85 (28 days after the second vaccination)
Secondary	GMT of SARS-CoV-2 Antibodies Against Original Strain (Part 2)		Day 85 (28 days after the second vaccination)
Secondary	Seroresponse Rate Against SARS-CoV-2 Original Strain (Part 2)		Day 85 (28 days after the second vaccination)