Clinical trial NCT05584202: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: SARS-CoV-2
Keywords: mRNA-1273
mRNA-1273 vaccine
mRNA-1273.214 vaccine
mRNA-1273.214
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID 19
COVID 19 Vaccine
Moderna
Bivalent omicron vaccine
Omicron vaccine
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-18
Enrollment: 68
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Part 1: sequential Part 2: parallel
Primary purpose: PREVENTION

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 \[NCT04470427\]).

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.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 64 (7 days after each vaccination)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 85 (28 days after each vaccination)
measure: Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs)
timeFrame: Up to Day 422
measure: Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antibodies Against Omicron Variant
timeFrame: Day 85 (28 days after the second vaccination)
measure: Seroresponse Rate Against SARS-CoV-2 Omicron Variant
timeFrame: Day 85 (28 days after the second vaccination)
Secondary outcomes:
measure: GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 1)
timeFrame: Day 85 (28 days after the second vaccination)
measure: GMT of SARS-CoV-2 Antibodies Against Omicron Variant (Part 2)
timeFrame: Day 85 (28 days after the second vaccination)
measure: Seroresponse Rate Against SARS-CoV-2 Omicron Variant (Part 2)
timeFrame: Day 85 (28 days after the second vaccination)
measure: GMT of SARS-CoV-2 Antibodies Against Original Strain (Part 2)
timeFrame: Day 85 (28 days after the second vaccination)
measure: Seroresponse Rate Against SARS-CoV-2 Original Strain (Part 2)
timeFrame: Day 85 (28 days after the second vaccination)
Other outcomes:
Locations:
city: Bessemer
country: United States
facility: Trinity Clinical Research, LLC - Bessemer
state: Alabama
city: Birmingham
country: United States
facility: UAB Pediatrics
state: Alabama
city: Tucson
country: United States
facility: Eclipse Clinical Research
state: Arizona
city: Madera
country: United States
facility: Madera Family Medical Group
state: California
city: Montebello
country: United States
facility: SeraCollection Research Services LLC
state: California
city: Paramount
country: United States
facility: Center For Clinical Trials LLC
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Meridian Clinical Research (Washington) - PPDS
state: District of Columbia
city: Clearwater
country: United States
facility: PAS Research
state: Florida
city: Doral
country: United States
facility: Prohealth Research Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Jackonsville
state: Florida
city: Kissimmee
country: United States
facility: Kissimmee Clinical Research
state: Florida
city: Miami Gardens
country: United States
facility: Excellence Medical and Research LLC
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research
state: Florida
city: Miami
country: United States
facility: D&amp;H National Research Centers
state: Florida
city: Miami
country: United States
facility: Suncoast Research Associates LLC - ERN - PPDS
state: Florida
city: Saint Cloud
country: United States
facility: KM International Research Operation - Saint Cloud
state: Florida
city: Tampa
country: United States
facility: PAS Research
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Ammon
country: United States
facility: Medical Research Partners- Ammon
state: Idaho
city: Covington
country: United States
facility: MedPharmics - Platinum - PPDS
state: Louisiana
city: Lafayette
country: United States
facility: MedPharmics - Platinum - PPDS
state: Louisiana
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc
state: Minnesota
city: Lincoln
country: United States
facility: Be Well Clinical Studies
state: Nebraska
city: East Syracuse
country: United States
facility: Child Health Care Associates
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Wilmington
country: United States
facility: Velocity Clinical Research (Hastings - Nebraska) - PPDS
state: North Carolina
city: Pittsburgh
country: United States
facility: UPMC University Center
state: Pennsylvania
city: Charleston
country: United States
facility: Coastal Pediatric Research
state: South Carolina
city: Corpus Christi
country: United States
facility: South Texas Clinical Research - Corpus Christi
state: Texas
city: Dallas
country: United States
facility: Cedar Health Research - Dedicated Research Facility
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Kool Kids Pediatrics - ERN - PPDS
state: Texas
city: Pearland
country: United States
facility: Advances In Health Inc
state: Texas
city: Port Lavaca
country: United States
facility: Victoria Clinical Research Group
state: Texas
city: Layton
country: United States
facility: Tanner Clinic
state: Utah
city: Syracuse
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Burke
country: United States
facility: PI-Coor Clinical Research LLC
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
Study officials:
References: