Clinical trial NCT05436834: 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
Official title: An Open-Label, Phase 3 Study to Evaluate the Safety and Immunogenicity of mRNA Vaccines for SARS-CoV-2 Variants in Participants Aged 6 Months to < 6 Years
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: SARS-CoV-2
Keywords: Coronavirus disease 2019
COVID-19
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-29
Enrollment: 1860
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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).

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 8 (7 days post-vaccination)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 29 (28 days after each injection)
measure: Number of Participants with Medically-Attended AEs (MAAEs)
timeFrame: Up to Day 394 (12 months after last dose)
measure: Number of Participants with Serious AEs (SAEs)
timeFrame: Up to Day 394 (12 months after last dose)
measure: Number of Participants with Adverse Events of Special Interest (AESI)
timeFrame: Up to Day 394 (12 months after last dose)
measure: Number of Participants with AEs Leading to Withdrawal
timeFrame: Up to Day 394 (12 months after last dose)
measure: 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
timeFrame: Day 57
measure: GM of the Serum Ab Level against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration at Day 29
timeFrame: Day 29
measure: Seroresponse Rate (SRR) against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration
timeFrame: Day 29
measure: GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration
timeFrame: Up to Day 57
Secondary outcomes:
measure: SRR against Omicron BA.1 and Ancestral SARS-CoV-2 after mRNA-1273.214 Administration Regardless of prior SARS-CoV-2 Infection
timeFrame: Day 57
measure: GM of the Serum Ab Level against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection
timeFrame: Up to Day 57
measure: SRR against Omicron XBB.1.5 after mRNA-1273.815 Administration Regardless of prior SARS-CoV-2 Infection
timeFrame: Up to Day 57
Other outcomes:
Locations:
city: Bessemer
country: United States
facility: Trinity Clinical Research, LLC
state: Alabama
city: Banning
country: United States
facility: Velcocity Clinical Research
state: California
city: Montebello
country: United States
facility: Sera Collection Research Services
state: California
city: Paramount
country: United States
facility: Center For Clinical Trials LLC -Paramount
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Washington
country: United States
facility: Meridian Clinical Research
state: District of Columbia
city: Doral
country: United States
facility: Prohealth Research Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Jacksonville
state: Florida
city: Kissimmee
country: United States
facility: Kissimmee Clinical Research
state: Florida
city: Miami
country: United States
facility: Med-Care Research
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Decatur
country: United States
facility: IResearch
state: Georgia
city: Macon
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Meridian
country: United States
facility: Velcocity Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Lurie Childrens Hospital
state: Illinois
city: Overland Park
country: United States
facility: Meridian Clinical Research
state: Kansas
city: Lexington
country: United States
facility: Michael W. Simon MD, PSC
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Lafayette
country: United States
facility: Velocity Clinical Research - Lafayette - PPDS
state: Louisiana
city: Metairie
country: United States
facility: MedPharmics
state: Louisiana
city: Metairie
country: United States
facility: Velocity Clinical Research - Covington - PPDS
state: Louisiana
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Hastings
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies, LLC - Lincoln - ERN - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Albuquerque
country: United States
facility: Velocity Clinical Research
state: New Mexico
city: Binghamton
country: United States
facility: Meridian Clinical Research
state: New York
city: E. Amherst
country: United States
facility: WellNow Urgent Care Clinical Research
state: New York
city: East Syracuse
country: United States
facility: Child Healthcare Associates - East Syracuse
state: New York
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: East Greenwich
country: United States
facility: Velcocity Clinical Research
state: Rhode Island
city: Charleston
country: United States
facility: Coastal Pediatric Associates
state: South Carolina
city: Charleston
country: United States
facility: Meridian Clinical Research
state: South Carolina
city: Charleston
country: United States
facility: MUSC
state: South Carolina
city: Memphis
country: United States
facility: Le Bonheur Childrens Hospital
state: Tennessee
city: Austin
country: United States
facility: Velocity Clinical Research Austin
state: Texas
city: Beaumont
country: United States
facility: REX Clinical Trials, LLC Beaumont
state: Texas
city: Cedar Park
country: United States
facility: Velcocity Clinical Research
state: Texas
city: Edinburg
country: United States
facility: BRCR Global Texas
state: Texas
city: Frisco
country: United States
facility: Village Health Partners - Frisco Medical Village
state: Texas
city: Houston
country: United States
facility: Ventavia Research Group
state: Texas
city: Houston
country: United States
facility: Cyfair Clinical Reseach Center
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development
state: Texas
city: Victoria
country: United States
facility: Victoria Clinical Research Group
state: Texas
city: Burke
country: United States
facility: PI Coor Clinical Research LLC
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners
state: Virginia
city: Caba
country: Argentina
facility: AES - AS - Glenny Corp. S.A. Buenos Aires
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
state: Ciudad Autónoma De BuenosAires
city: San Miguel de Tucumán
country: Argentina
facility: AES - AS - Clinica Mayo de Urgencias
state: Tucumán
city: Ciudad Autónoma De Buenos Aires
country: Argentina
facility: Consultorios Médicos Dr. Doreski - PPDS
city: Santiago
country: Chile
facility: Centro de Estudios Clinicos e Investigaciones Medicas (CECIM)
state: Region Metropolitana
city: Medellin
country: Colombia
facility: AES - AS - Centro de Investigación Clínica CIC S.A.S (CECIC) Medellín
state: Antioquia
city: Barranquilla
country: Colombia
facility: Clínica de Costa S.A.S
state: Atlántico
city: Cartagena
country: Colombia
facility: Clínica de la Costa S.A.S- Sede Cartagena
state: Bolivar
city: Aguazul
country: Colombia
facility: Centro de Atencion e Investigacion Medica S.A.S. - CAIMED Aguazul
state: Casanare
city: Yopal
country: Colombia
facility: Centro de Atencion e Investigacion Medica S.A - Yopal - CAIMED
state: Casanare
city: Bogotá
country: Colombia
facility: Policlínico Social del Norte
state: Cundinamarca
city: Bogotá
country: Colombia
facility: AES- AS- Solano & Terront Servicios Médicos LTDA (UNIENDO) Bogotá
state: Distrito Capital De Bogotá
city: Acacias
country: Colombia
facility: Centro de Atención e Investigación Médica S.A.S.- CAIMED - S.A.S. Sede Acacias
state: Meta
city: Santo Domingo De Guzmán
country: Dominican Republic
facility: Caimed Dominicana S.A.S - CAIMED - PPDS
state: Distrito NacionalSanto Domingo
city: Higüey
country: Dominican Republic
facility: Registrum- La Altagracia
state: La Altagracia
city: Santo Domingo Este
country: Dominican Republic
facility: Hospital Materno Infantil San Lorenzo de Los Mina
state: Santo Domingo
city: Santo Domingo Iesta
country: Dominican Republic
facility: Hospital General Regional Dr. Marcelino Velez Santana
state: Santo Domingo
city: Santo Domingo
country: Dominican Republic
facility: Unidad de Vacunas e Investigación Instituto Dermatologico Dominicano y Cirugía de Piel Dr. Huberto B
city: Panama
country: Panama
facility: CAENSA Clinical Trial
city: Panama
country: Panama
facility: Centro De Vacunacion Internacional, S.A. - David - Cevaxin - PPDS
city: Panama
country: Panama
facility: CEVAXIN 24 de diciembre - PPDS
city: Panama
country: Panama
facility: CEVAXIN Avenida México - PPDS
city: Panama
country: Panama
facility: CEVAXIN Chorrera - PPDS
city: Panama
country: Panama
facility: Curaex Clinical Trial
city: Panama
country: Panama
facility: Instituto de Investigaciones Científicas y Servicios de Alta Tecnología Asociación de Interés Panama
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center
Study officials:
References: