A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age
- Conditions
- SARS-CoV-2
- Interventions
- Biological: mRNA-1273.214Biological: mRNA-1273.815
- Registration Number
- NCT05436834
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to \<6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose (BD) given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2); and will evaluate the safety and immunogenicity of the mRNA-1273.815 vaccine, when administered as a BD in participants aged 6 months to \<6 years (Part 3) and when administered to SARS-CoV-2 vaccine-naïve participants aged 2 years to \<5 years of age (Part 4).
- Detailed Description
Part 1 will enroll participants aged 6 months to \<6 years who have not been previously vaccinated against SARS-CoV-2. Participants will receive 2 doses of the mRNA-1273.214 vaccine.
Part 2 will enroll participants aged 6 months to \<6 years who have previously been vaccinated with a mRNA-1273 primary series in Study mRNA-1273-P204 (NCT04796896). Participants will receive a single BD of the mRNA-1273.214 vaccine, at least 4 months after completion of the mRNA-1273 primary series.
Part 3 will enroll participants aged 6 months to \<6 years who have previously been vaccinated with an authorized/approved COVID-19 vaccine. Participants will receive a BD of the mRNA-1273.815 vaccine at least 4 months after the last receipt of a COVID-19 vaccine.
Part 4 will evaluate mRNA-1273.815 vaccine administered as a single dose to SARS-CoV-2 vaccine-naïve participants aged 2 years to \<5 years of age enrolled in Cohort A (Part 4A), compared to 2 doses given to SARS-CoV-2 vaccine-naïve participants aged 6 months to \<2 years enrolled in Cohort B (Part 4B).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1860
- The participant is 6 months to <6 years for Parts 1, 2, and 3; 2 years to <5 years for Part 4A; and 6 months to <2 years for Part 4B at the time of consent (Screening Visit). Note: for Part 1, participant must be at least 6 months old and must not have reached 6 years of age at the time of administration of first dose. For Part 4B, the participant must be at least 6 months old and must not have reached 2 years of age at the time of administration of first dose.
- If the participant has a chronic disease (that is, asthma, diabetes mellitus, cystic fibrosis, human immunodeficiency virus [HIV] infection), the disease should be stable, per investigator assessment, so that the participant can be considered eligible for inclusion. Stable diseases are those which have had no change in their status or in the medications required to control them in the 6 months prior to Screening Visit. Note: a change in medication for dose optimization (that is, insulin dose changes, adjustments for age-related weight gain), change within class of medication, or reduction in dose are not considered signs of instability.
- In the investigator's opinion, the parent(s)/legally authorized representative(s) (LAR[s]) understand and are willing and physically able to comply with protocol-mandated follow-up, including all procedures and provide written informed consent.
- The participant is 2 years or older and has a body mass index (BMI) at or above the second percentile according to World Health Organization (WHO) Child Growth Standards at the Screening Visit.
OR
- The participant is less than 2 years of age and the participant's height and weight are both at or above the second percentile according to WHO Child Growth Standards at the Screening Visit.
Special inclusion criteria for participants aged 6 months to < 12 months:
- The participant was born at full-term (≥ 37 weeks gestation) with a minimum birth weight of 2.5 kilograms (kg).
Inclusion criteria for Part 2:
- The participant must have received 2 doses of mRNA-1273, approximately 28 to 35 days apart, as 25-μg primary series, and second dose was given at least 4 months prior to enrollment.
Inclusion criteria for Part 3 only:
- The participant must have received an age-appropriate immunization series of an authorized/approved COVID-19 vaccine, with the last dose given at least 4 months prior to enrolment (Previous vaccines NOT allowed are: XBB.1.5-containing formulation).
-
Has a known history of SARS-CoV-2 infection (that is, reported AE of COVID-19 or asymptomatic SARS-CoV-2 infection during Study mRNA-1273-P204 at the time of rollover into mRNA-1273-P306 or during Part 1 at the time of rollover into Part 3) in the 90 days prior to dosing in this study.
-
Is acutely ill or febrile 24 hours prior to or at the Screening Visit. Fever is defined as a body temperature ≥ 38.0°Celsius (C)/≥ 100.4°Fahrenheit (F). 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.
-
For Parts 1 and 4, participant has previously been administered an investigational or approved CoV (that is, SARS-CoV-2, SARS-CoV, Middle East respiratory syndrome coronavirus [MERS-CoV]) vaccine. For Part 2, participant who received any approved/investigational CoV vaccine are ineligible to participate except for those who received mRNA-1273 (prototype) vaccine.
-
Has undergone treatment with investigational or approved agents for prophylaxis against COVID-19 (including receipt of SARS-CoV-2 monoclonal antibodies for prophylaxis or treatment) within 90 days prior to enrollment.
-
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 a previous dose of an mRNA COVID-19 vaccine or any of its components (including polyethylene glycol [PEG] or immediate allergic reaction of any severity to polysorbate).
-
Has a medical or psychiatric 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.
-
Has a history of diagnosis or condition that, in the judgment of the investigator, may affect study endpoint assessment or compromise participant safety, specifically the following:
- Congenital or acquired immunodeficiency, other than well-controlled HIV infection.
- Chronic hepatitis or suspected active hepatitis
- A bleeding disorder that is considered a contraindication to IM injection or phlebotomy
- Dermatologic conditions that could affect local solicited AR assessments
- Any prior diagnosis of malignancy (excluding nonmelanoma skin cancer)
-
Has received the following:
- Any routine vaccination with inactivated or live vaccine(s) within 14 days prior to study vaccination or plans to receive such a vaccine through 14 days following study vaccination.
Note: This excludes influenza vaccine that may be given anytime, but ideally at least 7 days before study dose. If a participant receives an influenza vaccine, this should be captured within the concomitant medication electronic case report form (eCRF).
- Systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the day of enrollment (for corticosteroids, ≥1 milligrams (mg)/kg/day or ≥ 10 mg/day prednisone equivalent, if participant weighs >10 kg). Participants may have visits rescheduled for enrollment if they no longer meet this criterion within the Screening Visit window. Inhaled, nasal, and topical steroids, and palivizumab are allowed.
- Intravenous (IV) or subcutaneous (SC) blood products (red cells, platelets, immunoglobulins) within 3 months prior to enrollment.
Note: Other inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description mRNA-1273.214 (Part 1) mRNA-1273.214 Participants who have not been previously vaccinated against SARS-CoV-2, will receive 2 intramuscular (IM) injections of mRNA-1273.214 vaccine on Day 1 and Day 29. mRNA-1273.214 (Part 2) mRNA-1273.214 Participants who have previously been vaccinated with a mRNA-1273 primary series, will receive a single IM BD of mRNA-1273.214 vaccine at least 4 months after completion of the mRNA-1273 primary series. mRNA-1273.815 (Part 4) mRNA-1273.815 Participants in Part 4 Cohort A will receive a single IM injection of mRNA-1273.815 vaccine on Day 1. Participants in Part 4 Cohort B will receive IM injections of mRNA-1273.815 vaccine on Day 1 and Day 29. mRNA-1273.815 (Part 3) mRNA-1273.815 Participants who have previously been vaccinated with an authorized/approved COVID-19 vaccine, will receive a single IM BD of mRNA-1273.815 vaccine on BD Day 1, at least 4 months after the last dose of a COVID-19 vaccine.
- Primary Outcome Measures
Name Time Method Number of Participants with Serious AEs (SAEs) Up to Day 394 (12 months after last dose) Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) Up to Day 8 (7 days post-vaccination) Number of Participants with Unsolicited Adverse Events (AEs) Up to Day 29 (28 days after each injection) Number of Participants with Medically-Attended AEs (MAAEs) Up to Day 394 (12 months after last dose) GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration Up to Day 57 Number of Participants with Adverse Events of Special Interest (AESI) Up to Day 394 (12 months after last dose) Number of Participants with AEs Leading to Withdrawal Up to Day 394 (12 months after last dose) Seroresponse Rate (SRR) against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration Day 29 Geometric Mean (GM) of the Serum Antibody (Ab) Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 57 Day 57 GM of the Serum Ab Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 29 Day 29
- Secondary Outcome Measures
Name Time Method SRR against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration Regardless of prior SARS-CoV-2 Infection Day 57 GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection Up to Day 57 SRR against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection Up to Day 57
Trial Locations
- Locations (65)
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
🇦🇷Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina
AES - AS - Glenny Corp. S.A. Buenos Aires
🇦🇷Caba, Ciudad Autónoma De Buenos Aires, Argentina
AES - AS - Clinica Mayo de Urgencias
🇦🇷San Miguel de Tucumán, Tucumán, Argentina
Consultorios Médicos Dr. Doreski - PPDS
🇦🇷Ciudad Autónoma De Buenos Aires, Argentina
Trinity Clinical Research, LLC
🇺🇸Bessemer, Alabama, United States
Velcocity Clinical Research
🇺🇸Cedar Park, Texas, United States
Sera Collection Research Services
🇺🇸Montebello, California, United States
Center For Clinical Trials LLC -Paramount
🇺🇸Paramount, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Meridian Clinical Research
🇺🇸Charleston, South Carolina, United States
Prohealth Research Center
🇺🇸Doral, Florida, United States
University of Florida Jacksonville
🇺🇸Jacksonville, Florida, United States
Kissimmee Clinical Research
🇺🇸Kissimmee, Florida, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Med-Care Research
🇺🇸Miami, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
IResearch
🇺🇸Decatur, Georgia, United States
Lurie Childrens Hospital
🇺🇸Chicago, Illinois, United States
Michael W. Simon MD, PSC
🇺🇸Lexington, Kentucky, United States
Velocity Clinical Research - Lafayette - PPDS
🇺🇸Lafayette, Louisiana, United States
MedPharmics
🇺🇸Metairie, Louisiana, United States
Velocity Clinical Research - Covington - PPDS
🇺🇸Metairie, Louisiana, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
University of Missouri Health Care
🇺🇸Columbia, Missouri, United States
Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS
🇺🇸Lincoln, Nebraska, United States
Quality Clinical Research
🇺🇸Omaha, Nebraska, United States
Velocity Clinical Research
🇺🇸Albuquerque, New Mexico, United States
WellNow Urgent Care Clinical Research
🇺🇸E. Amherst, New York, United States
Child Healthcare Associates - East Syracuse
🇺🇸East Syracuse, New York, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Coastal Pediatric Associates
🇺🇸Charleston, South Carolina, United States
MUSC
🇺🇸Charleston, South Carolina, United States
Le Bonheur Childrens Hospital
🇺🇸Memphis, Tennessee, United States
Velocity Clinical Research Austin
🇺🇸Austin, Texas, United States
REX Clinical Trials, LLC Beaumont
🇺🇸Beaumont, Texas, United States
BRCR Global Texas
🇺🇸Edinburg, Texas, United States
PI Coor Clinical Research LLC
🇺🇸Burke, Virginia, United States
Village Health Partners - Frisco Medical Village
🇺🇸Frisco, Texas, United States
Ventavia Research Group
🇺🇸Houston, Texas, United States
Cyfair Clinical Reseach Center
🇺🇸Houston, Texas, United States
Texas Center for Drug Development
🇺🇸Houston, Texas, United States
Victoria Clinical Research Group
🇺🇸Victoria, Texas, United States
Clinical Research Partners
🇺🇸Richmond, Virginia, United States
Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
🇨🇱Santiago, Region Metropolitana, Chile
AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medellín
🇨🇴Medellin, Antioquia, Colombia
Clínica de Costa S.A.S
🇨🇴Barranquilla, Atlántico, Colombia
Clínica de la Costa S.A.S- Sede Cartagena
🇨🇴Cartagena, Bolivar, Colombia
Centro de Atencion e Investigacion Medica S.A.S. - CAIMED Aguazul
🇨🇴Aguazul, Casanare, Colombia
Centro de Atencion e Investigacion Medica S.A - Yopal - CAIMED
🇨🇴Yopal, Casanare, Colombia
Policlínico Social del Norte
🇨🇴Bogotá, Cundinamarca, Colombia
AES- AS- Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogotá
🇨🇴Bogotá, Distrito Capital De Bogotá, Colombia
Centro de Atención e Investigación Médica S.A.S.- CAIMED - S.A.S. Sede Acacias
🇨🇴Acacias, Meta, Colombia
Caimed Dominicana S.A.S - CAIMED - PPDS
🇩🇴Santo Domingo De Guzmán, Distrito NacionalSanto Domingo, Dominican Republic
Registrum- La Altagracia
🇩🇴Higüey, La Altagracia, Dominican Republic
Hospital Materno Infantil San Lorenzo de Los Mina
🇩🇴Santo Domingo Este, Santo Domingo, Dominican Republic
Hospital General Regional Dr. Marcelino Velez Santana
🇩🇴Santo Domingo Iesta, Santo Domingo, Dominican Republic
Unidad de Vacunas e Investigación Instituto Dermatologico Dominicano y Cirugía de Piel Dr. Huberto B
🇩🇴Santo Domingo, Dominican Republic
CAENSA Clinical Trial
🇵🇦Panama, Panama
Centro De Vacunacion Internacional, S.A. - David - Cevaxin - PPDS
🇵🇦Panama, Panama
CEVAXIN 24 de diciembre - PPDS
🇵🇦Panama, Panama
CEVAXIN Avenida México - PPDS
🇵🇦Panama, Panama
CEVAXIN Chorrera - PPDS
🇵🇦Panama, Panama
Curaex Clinical Trial
🇵🇦Panama, Panama
Instituto de Investigaciones Científicas y Servicios de Alta Tecnología Asociación de Interés Panama
🇵🇦Panama, Panama
Caribbean Medical Research Center
🇵🇷San Juan, Puerto Rico